PEB - Pacific Edge Ltd

[Minerbarejet]

1. CMS possible windfall on completed tests once fully signed up- late 2014 early 2015
2. Kaiser HMO possible sign up with a further link to Johns Hopkins in Baltimore - Feb
3. ARHQ Draft cxbladder contribution based on one measly test #52.O'Sullivan 2012. Expect better from full report. - Feb
4. Colorectal ready for market possibly into Japan as a joint venture
5. CxBladder triage for release late 2014 in NZ
6. Developing Melanoma and Gastric probably with Callaghan Grants for 4.5 mil over 3 years plus 2 years further grants possible
7. Online sales
8. 20 mil in the bank
9. Expanding sales force
10. CFO hired

11. Have a nice day

[Balance]

I would have to agree because there wouldn't be a lot of investors apart from a few on this thread who actually undertstand the intricacies of PEB's market development situation, and the actual figures will be largely meaningless to a lot of people. This is still a speculative stock and hardly ready for analysis using normal methods. A couple of articles in the ODT and Herald and the explanatory comments of DD and Swann (i.e. commentary) will probably have more impact than the release of figures that have to be explained in detail to the uninitiated. Even then, PEB will remain speculative and its SP will remain largely subjective. I've placed my bet and am sticking. Some of the cynics will drop out, the believers will remain in. The evidence seems to suggest that FY 2015 will give the analysts a much better steer. Yes, that means waiting another year.


PEB is now an index stock - means it is covered by analysts.

Means they will be ignoring what DD and Swan is hyping - they will be assessing PEB's progress against their expectations. Have a look at Forbar report for a steer of what is expected.

[MAC]

Hi Kild,

Large professional investors and the market generally understand how molecular biotech business models work, the strategic plan for the commercialisation of their products, and they know that early sales are relatively meaningless within such a plan.

Early random sales achieved, whilst engaging and training sales staff, and establishing a contact base for much more lucrative user programme roll overs, are certainly not an indicator of progress, nor are they at all indicative of a stock’s valuation.

A read of these links may serve you well, there is a methodology applied by analysts in valuing biotech stocks,

https://www.deloitte.com/view/en_us/us/insights/b6115312b90fb110VgnVCM100000ba42f00aRCRD.htm

http://www.investopedia.com/articles...hvaluation.asp (http://www.investopedia.com/articles/stocks/06/biotechvaluation.asp)

Genuinely hope this assists you

kind regards, Mac

[klid]

I've already read that second link, maybe you or someone posted it before. Agree with it all, but don't see how it's relevant to what's going to happen to the share price on results release.

Thanks for the commentary there Miner, hasn't convinced me to buy. Maybe if I hear it from Chris soon though, but really I will be looking for that sales figure with my finger on the trigger - expect others will too. Inital 10%+ gain/drop on the cards I'd say.

[BFG]

I'm guessing 127 tests in the US that have been paid for.

And I thought I was being bearish!!!

[BFG]

It pays to take history into account as well in cases like these. I remember the incredible hype surrounding the obesity pill market in the USA in 2011 & 2012. Arena Pharmaceuticals shot up after FDA approval with Belviq, then promptly tanked and has NEVER recovered as sales have since then been much less than expected. Vivus was next with Qysimia, which again shot up on FDA approval... then tanked... and never recovered. These companies are still yet to be profitable, even with a massive potential market, being US based and despite HUGE marketting schemes for their products.

Point is, the hype and excitement phase was great, but it never lasts. PEB needs to start delivering, and delivering WELL ABOVE ITS WEIGHT. If it cannot, this company will be another VVUS or ARNA, no matter what MAC says and not matter how many DCF models he makes.

ARNA chart: https://nz.finance.yahoo.com/q/bc?s=ARNA&t=5y&l=on&z=l&q=l&c=

VVUS chart: https://nz.finance.yahoo.com/q/bc?s=VVUS&t=5y

Read carefully:

IT IS NOT DIFFERENT THIS TIME!!!!

[winner69]

It pays to take history into account as well in cases like these. I remember the incredible hype surrounding the obesity pill market in the USA in 2011 & 2012. Arena Pharmaceuticals shot up after FDA approval with Belviq, then promptly tanked and has NEVER recovered as sales have since then been much less than expected. Vivus was next with Qysimia, which again shot up on FDA approval... then tanked... and never recovered. These companies are still yet to be profitable, even with a massive potential market, being US based and despite HUGE marketting schemes for their products.

Point is, the hype and excitement phase was great, but it never lasts. PEB needs to start delivering, and delivering WELL ABOVE ITS WEIGHT. If it cannot, this company will be another VVUS or ARNA, no matter what MAC says and not matter how many DCF models he makes.

ARNA chart: https://nz.finance.yahoo.com/q/bc?s=ARNA&t=5y&l=on&z=l&q=l&c=

VVUS chart: https://nz.finance.yahoo.com/q/bc?s=VVUS&t=5y

Read carefully:

IT IS NOT DIFFERENT THIS TIME!!!!

But BFG ...it's the commentary that matters

[psychic]

Gosh, are there any success stories at all?

[psychic]

Of course, there are loads of Pharma success stories, and plenty of disappointments,

I just don't see much relevance, but thanks for the warning BFG

[MAC]

Pacific Edge have provided a commercialisation plan Kild, and quite a comprehensive plan. Investors look for progress against that plan, sales at this point are not entirely irrelevant, but nor are they at this stage, really meaningful as an indicator of how the company is doing.

Molecular biotech stocks are not like IT stocks where a steady increase in revenues is required over years to achieve profitability based on scales of economy.

Molecular biotech stocks like pacific edge can and often do go from preliminary sales levels as at present to being a profitable company within a single reporting period. That’s because they tend to have low volume high margin business models. Once they get to a point on the plan with one or more commercial agreements in place they then become profitable companies.

Analyst estimates are for profitability to occur between HY16 and FY17.

At reporting time most shareholders just wish to assess progress toward that point based on the commentary provided, affirmation of the five year goal, progress on specific CMS and HMO negotiations, and an outlook for the coming year.

Pacific Edge are on track IMO, like most shareholders, I’m looking for a confirmation of progress within this report as a six monthly check.

No one is trying to convince you to invest, do as you may choose, many like Miner and myself are just here to share analysis and research. However, if you are just look for a quick buck off the back of a half year report, well then, good luck to you.

[Ginger_steps_]

It pays to take history into account as well in cases like these. I remember the incredible hype surrounding the obesity pill market in the USA in 2011 & 2012. Arena Pharmaceuticals shot up after FDA approval with Belviq, then promptly tanked and has NEVER recovered as sales have since then been much less than expected. Vivus was next with Qysimia, which again shot up on FDA approval... then tanked... and never recovered. These companies are still yet to be profitable, even with a massive potential market, being US based and despite HUGE marketting schemes for their products.

Point is, the hype and excitement phase was great, but it never lasts. PEB needs to start delivering, and delivering WELL ABOVE ITS WEIGHT. If it cannot, this company will be another VVUS or ARNA, no matter what MAC says and not matter how many DCF models he makes.

ARNA chart: https://nz.finance.yahoo.com/q/bc?s=ARNA&t=5y&l=on&z=l&q=l&c=

VVUS chart: https://nz.finance.yahoo.com/q/bc?s=VVUS&t=5y

Read carefully:

IT IS NOT DIFFERENT THIS TIME!!!!

Ummmm...... your basing your argument on stocks that rose on FDA approval against a company that doesn't require FDA approval? Weight loss drugs against cancer detection tests? Talk about comparing apples with monkeys!!! Starting to sound like a 15 year old that thinks he has the world figured out there BFG. My guess is that you googled biotech stocks that crashed and kindly shared your search results with us. Why not type in biotech stocks that boomed and offer some objectivity in your argument? Or for a little relevance in your argument - biotech cancer detection stocks.

[Minerbarejet]

I'm guessing 127 tests in the US that have been paid for.
Roflmao:lol: gee dentie you sure know how to hurt a guy. Less tests than the previous 6 months, hahahah:)

[Dentie]

Roflmao:lol: gee dentie you sure know how to hurt a guy. Less tests than the previous 6 months, hahahah:)

I just allowed myself to be influenced by Snapiti .... :eek2:

[winner69]

When is the big day anyway

If commentary really fantastic will need to be quick off the mark.

If not so good no rush as a few days or so to go sub 60 again before another trade?

[skid]

Ummmm...... your basing your argument on stocks that rose on FDA approval against a company that doesn't require FDA approval? Weight loss drugs against cancer detection tests? Talk about comparing apples with monkeys!!! Starting to sound like a 15 year old that thinks he has the world figured out there BFG. My guess is that you googled biotech stocks that crashed and kindly shared your search results with us. Why not type in biotech stocks that boomed and offer some objectivity in your argument? Or for a little relevance in your argument - biotech cancer detection stocks.

I think Snaps has mentioned a few that have boomed--how does PEB compare to them. I guess comparing PEB to a hep c cure drug and an Aids control drug is not really compareing Apples with Apples (but I think that was his point)

[couta1]

NMP22 FDA approved or not compared to Peb is still the B game, cheers

[skid]

Hi Kild,

Large professional investors and the market generally understand how molecular biotech business models work, the strategic plan for the commercialisation of their products, and they know that early sales are relatively meaningless within such a plan.

Early random sales achieved, whilst engaging and training sales staff, and establishing a contact base for much more lucrative user programme roll overs, are certainly not an indicator of progress, nor are they at all indicative of a stock’s valuation.

A read of these links may serve you well, there is a methodology applied by analysts in valuing biotech stocks,

https://www.deloitte.com/view/en_us/us/insights/b6115312b90fb110VgnVCM100000ba42f00aRCRD.htm

http://www.investopedia.com/articles...hvaluation.asp (http://www.investopedia.com/articles/stocks/06/biotechvaluation.asp)

Genuinely hope this assists you

kind regards, Mac

Then why are you ,along with all the others, sitting on the edge of your seat waiting for the sales figures to come out?

No matter how you fell about a company you cannot disregard the PRICE it costs to become a part owner--someone who buys at .65 is just as much a part owner as someone who bought at 1.75 (maybe more because they would have more shares for the same money.)

You just cant dismiss it--lets face it ,everyone is waiting for them,and those that have a memory of the last report are not going to dismiss as unimportant the result(whichever way it goes)

Im a bit surprised that even the most avid supporters seem to be preparing for low sales figures though(??)

2 weeks to go(probably) and look at the number of posts....Lets be realistic folks--It may be about Miners posts later--but its about sales now.

[MAC]

Nope, I’m looking forward to hearing about much more important things from Pacific Edge and some progress as to how they are going.

Goal affirmation, timeline for raising the sales force from 8 to 19, launch of the new products, timeline for entry into Asia and the strategy for that, any updates on discussion with prospective partners in Japan and the US for the colorectal and melanoma tests, etc.

Just the important wee things.

[Minerbarejet]

A few figures to mull over.
Snaps figure of lets say 520 over 6 months for ease of management
Gives you an average of 4 tests per day (520/(52*5)= 260 pa / 2 = 130 days *4 = 520
4 tests per day = 20 per week, WORLDWIDE . 40 hour week = 2 hrs per test. Spread over two labs its 4hrs per test

Hershey Lab capacity 200,000pa at 10% of market on a per diem is 770 tests
Thats 37.4 seconds per test
Its also $385,000 per day

4 tests per day, thats one each per day from Multiplan, Americas Choice, Fedmed and Stratose all with huge networks.

At 2 hrs per test there shouldnt be any mistakes.

There is plenty of capacity, cant wait to see them run out.:)

[Dentie]

Then why are you ,along with all the others, sitting on the edge of your seat waiting for the sales figures to come out?

No matter how you fell about a company you cannot disregard the PRICE it costs to become a part owner--someone who buys at .65 is just as much a part owner as someone who bought at 1.75 (maybe more because they would have more shares for the same money.)

You just cant dismiss it--lets face it ,everyone is waiting for them,and those that have a memory of the last report are not going to dismiss as unimportant the result(whichever way it goes)

Im a bit surprised that even the most avid supporters seem to be preparing for low sales figures though(??)

2 weeks to go(probably) and look at the number of posts....Lets be realistic folks--It may be about Miners posts later--but its about sales now.

I don't agree with your generalisations here Skid. Not everyone is sitting on the edge of their seats.

I reckon the only ones who are sitting that way are the ones who have the sole intention of trying to make some quick dosh. They are otherwise known as speculators (or traders) and are not at all interested in the good work the company is doing. Most of these participants would be equally happy on the racecourse, or in Sky City or just plain old lotto. I certainly don’t see them as “part owners” of the business and, in my view, don’t deserve to be on the balance sheet.


To be totally honest, I couldn’t care less what the sales figures are in a couple of weeks’ time and I dare say most of the REAL “part owners” of the company probably feel the same way – hence the long term stability at the top end of the shareholders list.


As a REAL part owner of PEB – from a business perspective, I am more than happy with where things are currently at and, if the gamblers start unloading – I’ll be happy to help the others absorb those shares.


However, if the “science” or “intellectual property” starts falling apart – or if there is some crazy decision making by those that matter…then that will be another story.

[Ginger_steps_]

You should do some more homework.....
Many insurance companies in the US have a written policy of not funding new products that are not FDA approvel...... that is why the developers of the nmp22 test choose to get FDA approved.
Just another thing PEB management are not telling you but the slows sales will.
Have you ever wondered why 2 of the biggest competitors to cx bladder are both FDA approved.

Instead of generalising, why dont you give us some examples, more importantly - specific to this type of biotech product? You seem very bent on disproving their model, so do it, factually.
Insurance companies are out to make money in any way they can, if they find a product which legally does not need FDA approval, can save them millions, and is proven better than incumbents - i think they will quickly find a way to incorporate it.

[winner69]

However, if the “science” or “intellectual property” starts falling apart – or if there is some crazy decision making by those that matter…then that will be another story.

So not really a REAL part owner then Dentie

Bail if not going to plan .... sounds like speculation \trading to me

I would contend that shareholders aren't owners anyway. They are just another supplier - the supplier of capital

[Dentie]

So not really a REAL part owner then Dentie

Bail if not going to plan .... sounds like speculation \trading to me

I would contend that shareholders aren't owners anyway. They are just another supplier - the supplier of capital

No Winner – IMVHO, the science and intellectual property is what forms the basis of their actual business. So long as they are intact – they still have a worthwhile business. The “plan” is how they go about marketing & selling that business to its market.

The shareholders are the REAL owners of the business – because they supply the “equity” based capital and thus get to gain the benefits of ownership (eg - Dividends). The other suppliers of capital are “debt” based and get the benefits of interest.
Of course – PEB don’t currently have any debt….which is another reason why I’m attracted to them!

[Minerbarejet]

No Winner – IMVHO, the science and intellectual property is what forms the basis of their actual business. So long as they are intact – they still have a worthwhile business. The “plan” is how they go about marketing & selling that business to its market.

The shareholders are the REAL owners of the business – because they supply the “equity” based capital and thus get to gain the benefits of ownership (eg - Dividends). The other suppliers of capital are “debt” based and get the benefits of interest.
Of course – PEB don’t currently have any debt….which is another reason why I’m attracted to them!I like that word "dividend " in there, Dentie. At full steam ahead and 385,000 a day at full capacity one would assume a distinct possibility of one being paid.
At XL that might not be too bad at all. Tax paid of course.:)

[winner69]

No Winner – IMVHO, the science and intellectual property is what forms the basis of their actual business. So long as they are intact – they still have a worthwhile business. The “plan” is how they go about marketing & selling that business to its market.

The shareholders are the REAL owners of the business – because they supply the “equity” based capital and thus get to gain the benefits of ownership (eg - Dividends). The other suppliers of capital are “debt” based and get the benefits of interest.
Of course – PEB don’t currently have any debt….which is another reason why I’m attracted to them!

So where the employees, especially the scientists, fit in - as suppliers of as the intelligence as well as the labour.

[Minerbarejet]

lol....... the more research I do the better investor I become so happy to have sold my PEB investment for an average of $1.31:t_up:
never fall in love with an investment it tends to give you a distorted, prejudiced opinion.

It's probably best to let the sales do all the talking.
I gotta go as my inflated ego has a date with some crayfish and paua very early tomorrow.I trust you are leaving the scuba tanks behind if you want both.
Cheers
B Careful

[robbo24]

Snaps, it is very magnanimous and generous of you to contribute to this thread; however, it would be much more beneficial if it wasn’t such a sceptical critique delivered by your hyper inflated ego and all based on your intolerant, prejudiced, petty and distorted opinion; or in other words ‘gob-$#!TE’ me thinks eh?

:D :D :D :D :D :D :D :D

This^

:D :D :D :D:D:D:D:D:D:D :D:D

[Minerbarejet]

This^

:D :D :D :D:D:D:D:D:D:D :D:D
An amazing piece of artwork , note the minor gaps between items 1-2, 2-3, 3-4, followed by a smooth brushstroke across until we get a reminder at 10 - 11. An astute piece of work fulfilling the needs of a desperate community clamouring for something other than facebook.

[BFG]

I certainly don’t see them as “part owners” of the business and, in my view, don’t deserve to be on the balance sheet.

To be totally honest, I couldn’t care less what the sales figures are in a couple of weeks’ time and I dare say most of the REAL “part owners” of the company probably feel the same way

Hahaha, THIS GUY!

“All animals are equal, but some animals are more equal than others.”

Sums up the PEB bulls beautifully.

Enjoy Friday, 28 November boys ;)

[Schrodinger]

Hahaha, THIS GUY!

“All animals are equal, but some animals are more equal than others.”

Sums up the PEB bulls beautifully.

Enjoy Friday, 28 November boys ;)

100 "paid"

[Minerbarejet]

100 "paid"You mean they are going backwards?????????

[Casino]

You mean they are going backwards?????????

I wouldn't argue with a pro.

[Casino]

You should do some more homework.....
Many insurance companies in the US have a written policy of not funding new products that are not FDA approvel...... that is why the developers of the nmp22 test choose to get FDA approved.
Just another thing PEB management are not telling you but the slows sales will.
Have you ever wondered why 2 of the biggest competitors to cx bladder are both FDA approved.

FDA approval does not determine product reimbursement, which is solely determined by CMS
http://www.hudson.org/research/7264-fda-approval-does-not-mean-what-you-think-it-does-

For PEB to take the LDT route makes sense. Yes there is a stigma but it comes down to clinical utility. I think that's what people should focus on instead of operational results, which are meaningless at this stage.

[Dentie]

lol....... the more research I do the better investor I become so happy to have sold my PEB investment for an average of $1.31:t_up:
never fall in love with an investment it tends to give you a distorted, prejudiced opinion.

It's probably best to let the sales do all the talking.
I gotta go as my inflated ego has a date with some crayfish and paua very early tomorrow.

$1.31 is meaningless - without the average buy price as well.

[Dentie]

So where the employees, especially the scientists, fit in - as suppliers of as the intelligence as well as the labour.

No different than any other employee of any other business. No doubt they are being paid a healthy salary package - hopefully including something that gives them the opportunity of ownership as well - if they want it. Just because someone has intelligence - doesn't mean they have plenty of dosh. Brains and money don't necessarily reside together.

[winner69]

For what's it worth my working DCF has sales of $2m for FY15 .....heading to $100m in 2020

Valuation is 75cents/85cents so must be a load of rubbish eh.

Anyway real revenues (sales only and not counting interest income and grants etc) around $1m for H1 would be tracking my assumptions .....but it the commentary that's paramount.

[skid]

I don't agree with your generalisations here Skid. Not everyone is sitting on the edge of their seats.

I reckon the only ones who are sitting that way are the ones who have the sole intention of trying to make some quick dosh. They are otherwise known as speculators (or traders) and are not at all interested in the good work the company is doing. Most of these participants would be equally happy on the racecourse, or in Sky City or just plain old lotto. I certainly don’t see them as “part owners” of the business and, in my view, don’t deserve to be on the balance sheet.


To be totally honest, I couldn’t care less what the sales figures are in a couple of weeks’ time and I dare say most of the REAL “part owners” of the company probably feel the same way – hence the long term stability at the top end of the shareholders list.


As a REAL part owner of PEB – from a business perspective, I am more than happy with where things are currently at and, if the gamblers start unloading – I’ll be happy to help the others absorb those shares.


However, if the “science” or “intellectual property” starts falling apart – or if there is some crazy decision making by those that matter…then that will be another story.


OK,maybe that was a bit dramtic,but
ATM the sales figures are the only way to gauge how PEB is selling its product Dents--I find it hard to believe you are not waiting to see an indication of how they are doing--Maybe I should correct my statement--there are those who are anxiously waiting the sales announcement-and those who respond to those who are waiting for the sales announcement.

Now lets talk about your generalizations--alot of those who are interested in the sales are not wanting to lose money rather than make a quick buck (like you should be if you have really mortgaged your house)
Those that have shares are just as much REAL part owners as you are(plain and simple) and Im sure most care how the company is doing.
I cared how the company was doing and got burned so I believe it is safer to wait till they have a bit more of a track record with selling their product to get back in(unless it falls to a point that it seems cheap enough to give them the benefit of the doubt.
You dont get a gold badge for being on board with your investing strategy.Your statement about some investors not deserving to be on the balance sheet is irrelevant--the ARE on the balance sheet--hence the SP.
Do I need to get into the racecourse and sky city scenario, in terms of your decision to mortgage the house?
i think your fooling yourself if you think you dont care about the sales (a gauge of how the co. is doing ) but if its true,then fair enough ,each to his own(I dont expect to be hearing from you in the frenzy of posts when this comes out then)
""science and intellectual property''doesnt sell itself--It could be a while before they really get on their feet--theres alot of dosh that COULD be lost in the meantime (good to know you'll be around to buy it up-2nd mortgage?)
we all know that some are in the game purely for speculation ,but not all are in that group that have expressed reservations--(there are alot of prudent investors in that group who want more of a sign that alls well before throwing their dosh at this (sounds like the opposite of gambling to me)
If you go back and read my posts you will see that I am just bringing up things for thinking about -not slagging .
Im open to the very real possibility things will be good in terms of sales and the SP will reflect that-or the opposite and the SP will also reflect that (and the value of your shares will either increase or drop) But the sales ARE going to influence the value of the shares so mayby you should be keeping an eye on them.
Maybe I have generalized and some just dont think the sales coming up are important,but I find that hard to believe--Maybe in a year or two it wont make much difference but we are NOW.
PEB will still be around in the future(I think)--dont criticize those who decide to wait for a confirmation that they are going to sell their product before joining up.

[skid]

Nope, I’m looking forward to hearing about much more important things from Pacific Edge and some progress as to how they are going.

Goal affirmation, timeline for raising the sales force from 8 to 19, launch of the new products, timeline for entry into Asia and the strategy for that, any updates on discussion with prospective partners in Japan and the US for the colorectal and melanoma tests, etc.

Just the important wee things.

Fair enough....But are you interested in the Share price?

[BFG]

Fair enough....But are you interested in the Share price?

Of course not. Even if sales don't eventuate the company will get bought up for a massive premium because they're BIG TIME with the BIG BOYS now. Even if that doesn't happen they're worth squillions because of the R&D.

Haven't you heard Skid?

IT'S DIFFERENT THIS TIME :D

[winner69]

Of course not. Even if sales don't eventuate the company will get bought up for a massive premium because they're BIG TIME with the BIG BOYS now. Even if that doesn't happen they're worth squillions because of the R&D.

Haven't you heard Skid?

IT'S DIFFERENT THIS TIME :D

Just like that vodka company. Best vodka (a gold standard) in the world and even though had glamorous sales channels couldn't make a buck .....but worth a lot to somebody.


So what is PEB worth to somebody else? That is the key question seeing profitability is a word that s not in PEBs dictionary.

I reckon a buck is a nice round number, sometime

[klid]

Cor blimey, now I can buy for $0.80! She's getting cheaper by the day, let them keep rolling :)

[skid]

To some outfit that had a stable of products and a well oiled marketing machine--It would be a fabulous addition--How well they are doing in the meantime would probably establish the price, but we are getting ahead of ourselves ..

[skid]

Can't expect to hear anything overly intelligent until the results come out, so come back in 2 weeks :)

you wont need to do that Klid--the sales are of no importance:):):)

[winner69]

To some outfit that had a stable of products and a well oiled marketing machine--It would be a fabulous addition--How well they are doing in the meantime would probably establish the price, but we are getting ahead of ourselves ..

Are we getting ahead of ourselves though? Maybe been the plan the whole time.

[skid]

Cant see that happening ,but if it was the plan,there would some who would need years of therapy from seeing THEIR co. being sold:)

[couta1]

No wonder I have mostly stopped posting on this thread and website. its just the same endless drivel from the same bunch of self-congratulatory keyboard warriors. Seriously underwhelming stuff, guys.
Yep more manure on here than your average dairy farm just noise for all those long termers.

[Dentie]

I cared how the company was doing and got burned so I believe it is safer to wait till they have a bit more of a track record with selling their product to get back in(unless it falls to a point that it seems cheap enough to give them the benefit of the doubt.

Do I need to get into the racecourse and sky city scenario, in terms of your decision to mortgage the house?
i think your fooling yourself if you think you dont care about the sales
""science and intellectual property''doesnt sell itself--It could be a while before they really get on their feet--theres alot of dosh that COULD be lost in the meantime
But the sales ARE going to influence the value of the shares so mayby you should be keeping an eye on them.


Skid, you only lose money (or get burned) if you choose to get out of the game by selling. If you believe in the company and there is an intention to come back in, why bother selling? Although PEB have been building for over a decade, the actual selling side of the business is still very much in its embryonic stage and there is still a long way to go. I have been in PEB for years and had the SP bumping along at sub .20 for ages so this is why I couldn't care less what the next lot of sales figures are. In the big scheme of things...it means sod all.

As for the mortgage thing ...well, along with the other bits - I thought the "tongue in cheek" thing was obvious. Wasn't trying to mislead...

[skid]

Yep more manure on here than your average dairy farm just noise for all those long termers.

then just ignore it Couts--no need to post...

[skid]

Skid, you only lose money (or get burned) if you choose to get out of the game by selling. If you believe in the company and there is an intention to come back in, why bother selling? Although PEB have been building for over a decade, the actual selling side of the business is still very much in its embryonic stage and there is still a long way to go. I have been in PEB for years and had the SP bumping along at sub .20 for ages so this is why I couldn't care less what the next lot of sales figures are. In the big scheme of things...it means sod all.

As for the mortgage thing ...well, along with the other bits - I thought the "tongue in cheek" thing was obvious. Wasn't trying to mislead...

Well,thats not quite true dents.
Have a look at Klids situation a while back--He felt the SP was a bit overcooked at the time so he sold in the hopes he could buy back in a little later.--In the end he bought (with approx the same money) More Shares ----and to boot,when he got the paperwork they said he was a REAL holder.
From what I could gather he still liked the company through the whole process.(it was a price issue)

So while you dont lose shares by not selling -you do lose value (which in his case resulted in more shares to purchase than he had before)

If that doesnt make sense ,then I could easily get my hands on a parcel to do an off market transfer to you at the ''undervalued by Mac'' share price of $1.70

Its not a marriage...

My mistake---Glad to hear you didnt really mortgage the house:)

[Dentie]

Well,thats not quite true dents.
Have a look at Klids situation a while back--He felt the SP was a bit overcooked at the time so he sold in the hopes he could buy back in a little later.--In the end he bought (with approx the same money) More Shares ----and to boot,when he got the paperwork they said he was a REAL holder.
From what I could gather he still liked the company through the whole process.(it was a price issue)

So while you dont lose shares by not selling -you do lose value (which in his case resulted in more shares to purchase than he had before)

:)

I don't like being too cute in that respect. I am always constantly very wary of the "other" market participant who slithers around in the background very quietly monitoring things - who says nothing. Get it wrong and I bet it will end in tears ... ignore this participant at your peril!

[Tsuba]

No wonder I have mostly stopped posting on this thread and website. its just the same endless drivel from the same bunch of self-congratulatory keyboard warriors. Seriously underwhelming stuff, guys.

I agree totaly with you on this. You tend to lose the will to live after reading a lot of that crap.I honestly think some of these people are completely lacking in a life beyond their keyboard and google surfing. :bored: Off to do something constructive like working in the garden. Getting ones hands dirty is probably beyond some of the keyboard pushing dicks here.

[skid]

I don't like being too cute in that respect. I am always constantly very wary of the "other" market participant who slithers around in the background very quietly monitoring things - who says nothing. Get it wrong and I bet it will end in tears ... ignore this participant at your peril!

Get it wrong and you have to pay more for getting back in-(but hopefully in an established uptrend)-Its just two sides to the coin..personally,dont really think there is any need to waste your time envisioning evil Gollum like creatures waiting in the background,but each to their own.

[skid]

I agree totaly with you on this. You tend to lose the will to live after reading a lot of that crap.I honestly think some of these people are completely lacking in a life beyond their keyboard and google surfing. :bored: Off to do something constructive like working in the garden. Getting ones hands dirty is probably beyond some of the keyboard pushing dicks here.

Good on ya Tsuba (unfortunately in my case it would be mud instead of dirt:) (glad I got the lawns out of the way yesterday!)

I do agree with you thats its definetely thereputic to get into some good ole honest down to earth garden work :)

[winner69]

Skid - even selling out at a buck would be a fantastic return on REAL investors money.

Nearly a 400% return on the $66m capital put in, fantastic. Even more fantastic for the early investors.

Probably has been the plan all along.

[klid]

Far out. Getting tempted now.

[ddrone]

Far out. Getting tempted now.

Not much to stop it crashing to 70 or so, watching waiting.

[Minerbarejet]

And all on no news. Amazing

[Balance]

And all on no news. Amazing

Don't assume 'no' news - the results are being collated and prepared for presentation next week.

[klid]

Next minute announcement Chris wants to do some home improvements.

sorry bad joke

[Dentie]

And all on no news. Amazing

No, no Miner...it will be these ones who have been taking notice of Snapiti's down-ramping while he's gone underwater looking for crays and paua.

Did you mention he was using scuba gear?

[Balance]

No, no Miner...it will be these ones who have been taking notice of Snapiti's down-ramping while he's gone underwater looking for crays and paua.

Did you mention he was using scuba gear?

Are you suggesting that the two big sellers who are jumping ahead of one another are reading this website?

Scary!

[klid]

I sold at 90/89/88. I would buy back in if it were greater than 1m, which it may well be, can we get some guesses going? :P
I will probably buy in before they announce sales, hoping for good news.

Bought at $0.77. Might add more to it depending on price/results.

[skid]

Are you suggesting that the two big sellers who are jumping ahead of one another are reading this website?

Scary!

Just had a look at depth and didnt see anything really big in the way of sales volume-(1 at 40,000)-Seems a bit early for insiders jumping ship so im finding the whole thing a bit weird--Its almost as if the news has already happened.--I guess stranger things have happened though.
Never a dull moment with PEB.

Bids a bit on the light side though

Guess you must be talking about the big sellers @ 84-85

[Minerbarejet]

No, no Miner...it will be these ones who have been taking notice of Snapiti's down-ramping while he's gone underwater looking for crays and paua.

Did you mention he was using scuba gear?
No, didnt say he was, just suggested he should leave his tanks behind if he wanted both crays and paua.:)

Personally Im all in favour of leaving these critters in peace for a while and let them recover.

(You can read that 2 ways)

CDY much more interesting at the moment

[skid]

The rally off the bottom (reversal -end of bear cycle??) paused for breath around the long term resistance (EMA200) which is common..

However..the 91c resistance wasn't broken convincingly as it had the EMA200 just above it forming a double barrier and now Mr Market is saying the pause is being seen as too long, and the technicals are weakening, triggering sell signals.

PEB going below 85c now sees another technical double barrier above the price,, the short term resistance line and the EMA50 resistance line both at 85c..Any short term positive movements (very risky) would be PEB closing above 87c and any positive long term (preferred risk option) action would be PEB price closing above 95c.. Indicating the pause (bull market correction) is over...

Going the other way there is strong support at the bull/bear line (78c)..If this line is broken the bear cycle resumes and the bottom (65c) becomes the focus of attention..

Short to Medium term TA investors won't be worried or be wasting time analysing the fundamental "ifs and buts" as they would be out of PEB by now..awaiting buy signals

http://i458.photobucket.com/albums/qq306/Hoop_1/PEB13112014.png (http://s458.photobucket.com/user/Hoop_1/media/PEB13112014.png.html)

Looks like Hoops downside theory about to be tested--seems a long way down to .65 but what do i know. (my logical mind tells me that this couldnt be the time for this sort of drop with no announcement yet)
still...all part of the education

[NT001]

Are you suggesting that the two big sellers who are jumping ahead of one another are reading this website? Scary!

Not only scary but unlikely, I would have thought. Any big investor would hardly want to waste time fighting through the jungle of conflicting and inane posts on this site. They'd consult their broker. It would be nice if we could be more civil to each other, even if we couldn't think of anything to say that's relevant to PEB.

[BFG]

Not only scary but unlikely, I would have thought. Any big investor would hardly want to waste time fighting through the jungle of conflicting and inane posts on this site. They'd consult their broker. It would be nice if we could be more civil to each other, even if we couldn't think of anything to say that's relevant to PEB.

Fair enough. I'm sure Snapiti would be willing to sacrifice a cattle beast for dinner. I'll bring the pumpkin pie. Miner is just up the road with the moonshine and I'm sure NBT could make a special trip in his lighter than air vehicular device to drop in.

Sound good guys? Shall we meet at mine? :D :D :D

[NT001]

This won’t affect the upcoming results, but may be of tangential interest to those who DTOR.

There’s been relatively heavy trading today and a slight SP rise in Aussie biotech company Cellmid, with which PEB has a close relationship, following an agreement by the world’s biggest animal health company Zoetis to buy an option to evaluate and licence Cellmid’s proprietary biomarker Midkine, which PEB uses in CxBladder. Midkine is a growth factor that modulates cell growth and is often found very early in disease onset, including cancer, even before any apparent physical symptoms.

PEB last year issued 1,084,622 milestone shares to Cellmid based on a license agreement signed in 2010 for the use of Midkine as one of the biomarkers in CxBladder. Milestone fee royalties will also be paid to Cellmid on Cxbladder revenues.

[skid]

In response to NTs post--I find It always helps to look at the bigger picture--family-freinds-living in an awesome country(while the majority of the world lives in poverty) we are the fortunate ones that for some reason got born into this lucky life.
Its a paradox that what we have ,sometimes leads to the stuff we are dealing with here.
If your thinking about the share market--you've most likely got enough food for your family.(seen the poverty first hand) --- nuff said

[Dentie]

what's has the average buy price got to do with it.

But for the record I thought PEB was a good risk versus reward investment when I bought the shares a 53 cps.


lol....... the more research I do the better investor I become so happy to have sold my PEB investment for an average of $1.31:t_up:

Well, your statement appeared to involve a bit of subtlety - but didn't have the buy price so it could be put into better perspective. I honestly congratulate you for your .78c gross return but presumably this is a taxable gain (given the hold time, the taxman may see you as a trader) plus you no longer hold the shares.

Given everyone's philosophy is different, I often wonder why some post what their gains (or losses) are on these threads.

[blackcap]

this is a taxable gain (given the hold time, the taxman may see you as a trader) .

I was under the impression that this is a commonly held misnomer and that hold time is not the vital factor when deciding if one is to be taxed on gains but rather intent at time of purchase?

[skid]

Is the tax an issue big enough to determine whether you hold or sell?(if so then those holding big paper losses should sell so they can write off the tax loss) the other side of paying tax on the profit.
Also one could argue that they bought to hold but sold only because things got scarey--ie-it was not the intention to speculate for profit.(it was simply self preservation)
In terms of no longer holding shares--he can buy any amount he wishes tomorrow(for a better or worse price) the shares will still be there.

So basically it comes down to price and value

We have had all sorts of debate on the value, and the price has been all over the place today-(which means that investors PERCEPTION of the value has been all over the place)-There just aint no easy answers at this point in time.

[klid]

I still have almost $7,000 to recoup on PEB.. maybe I could claim it as a loss :P

[couta1]

I still have almost $7,000 to recoup on PEB.. maybe I could claim it as a loss :P
You could but remember once a trader always a trader so you need to decide if all those years of scrutiny to come are worth 7k?(Actually only 2.33k in reality if your on the top tax rate)

[Whipmoney]

You could but remember once a trader always a trader so you need to decide if all those years of scrutiny to come are worth 7k?(Actually only 2.33k in reality if your on the top tax rate)

Actually that's not 100% correct.

When it comes to taxation share investing is rather different to property, I.e unlike property trading there isn't the associated 'taint' from trading.

One can ring fence part of their share portfolio for 'buy and hold' investing (generally non-taxable from a capital perspective) and another part for trading (which is a taxable activity).

[couta1]

Actually that's not 100% correct.

When it comes to taxation share investing is rather different to property, I.e unlike property trading there isn't the associated 'taint' from trading.

One can ring fence part of their share portfolio for 'buy and hold' investing (generally non-taxable from a capital perspective) and another part for trading (which is a taxable activity).
I'm not going to clutter the thread on this topic and I'm well aware of portfolio separation should one so choose that option but that wasn't the crux of my reply to Klid, cheers

[Minerbarejet]

I was under the impression that this is a commonly held misnomer and that hold time is not the vital factor when deciding if one is to be taxed on gains but rather intent at time of purchase?The intent should be clearly set out by placing the number of shares desired into a separate account as a long term hold for the express purposes of obtaining dividends eventually which would probably be tax paid at source. The declaration of a dividend from PEB seems a rather will o' the wisp thing at the moment. But if one arrived then all the shares held under those separate accounts would have their intent verified and currently not be subject to tax regardless of how much the share price may have improved. Any other shares would be in the trading account, subject to tax on realised gains and allowable for any claims for tax losses.

Thats how I'm handling mine and the accountant says its ok.:)

[klid]

Seems legit. Really all that on this page makes sense. Shares are a lot more transient than property and still can produce income.

But the answer is no I cannot claim it as a loss because the loss is being recuperated right now and will continue to do so since I bought today!:t_up:

[couta1]

Seems legit. Really all that on this page makes sense. Shares are a lot more transient than property and still can produce income.

But the answer is no I cannot claim it as a loss because the loss is being recuperated right now and will continue to do so since I bought today!:t_up:
Your onto it Klid and thats why it pays to think outside of the square, any losses claimed only return a max of 33% of your capital you forfeit the other 67% but if you do what you are doing you can gain back 100% of your loss completely legitimately.

[nextbigthing]

I wouldn't argue with a pro.

Yeah it certainly didn't do that ACDC drummer any good

[Dentie]

I was under the impression that this is a commonly held misnomer and that hold time is not the vital factor when deciding if one is to be taxed on gains but rather intent at time of purchase?

I'm not sure Blackcap - but it sounds like you may be correct. How does one prove intent? I think the way Miner is doing it looks sound enough. But then, if your "intent" is to invest (or hold long term) - why would you sell after what appears to be a short time - especially if the price started dropping? It must only be to lock in profits - and profit is taxable...as opposed to capital gain.

If you didn't then re-enter when the SP starts to rise again - then you could probably argue you were simply cashing in your long term capital gain. But, if you did re-enter, then the taxman could possibly argue you were trading afterall - trying to make ongoing short term gains.

Conversely, what if you were selling because you were making losses and wanted to limit those losses (as opposed to the above)?

What I do know, is that if your paperwork is not done properly and you can't prove your "intent" - or explain the difference between your paperwork and your actual historic share trades....then good luck with the taxman.

[robbo24]

So couta1 is snapiti, right?

[couta1]

So couta1 is snapiti, right?
Right about?

[BFG]

So couta1 is snapiti, right?

I thought he was Moose?

[Jay]

I'm not sure Blackcap - but it sounds like you may be correct. How does one prove intent? I think the way Miner is doing it looks sound enough. But then, if your "intent" is to invest (or hold long term) - why would you sell after what appears to be a short time - especially if the price started dropping? It must only be to lock in profits - and profit is taxable...as opposed to capital gain.

If you didn't then re-enter when the SP starts to rise again - then you could probably argue you were simply cashing in your long term capital gain. But, if you did re-enter, then the taxman could possibly argue you were trading afterall - trying to make ongoing short term gains.


In this context, Profit/Capital Gain - same thing as far as the Taxman is concerned
If you sold when the price dropped to preserve your capital, maybe an argument.
As you say comes down to intent.

There is another thread that discusses this issue - have a read of that

[skid]

You could but remember once a trader always a trader so you need to decide if all those years of scrutiny to come are worth 7k?(Actually only 2.33k in reality if your on the top tax rate)

I dont agree either on the ''once a trader'' statement--its intent

So by your statement ,i can only see 2 options--either hold long term -dont buy or sell (and accept the sometimes astronomical losses attached)
or hide from IRD...Neither of these options seem logical to me

[skid]

I still have almost $7,000 to recoup on PEB.. maybe I could claim it as a loss :P

Whoops--guess I shouldnt have used you as an example(must have been on previous trades)--but the point is still the same --I would venture to say you would be farther in the hole if you would have done nothing?

[skid]

I know TA is a dirty word to some ,but its interesting how the SP did bounce off Hoops bottom resistance yesterday(of 77)

[Leftfield]

Thank Hancocks, me thinks this a very useful attempt to help evaluate progress for PEB. Much appreciated.

[winner69]

Hancocks - question

Why do you add the Trade Receivables figure of $352k to the reported sales figure of $145k to get your notional total sales figure of $498k

Normally to be recognised as a Receivable the amounts involved are also recognised as / recorded as Revenues.

Just curious

[nextbigthing]

Please leave these posts up Hancock's :)

[psychic]

So Winner. you are good with ratting through these things. 31/3/14 Trade Receivables @ $353k inconsistent with Sales. Can "grants" etc be considered a trade receivable in PEB's case? thanks for help

[winner69]

So Winner. you are good with ratting through these things. 31/3/14 Trade Receivables @ $353k inconsistent with Sales. Can "grants" etc be considered a trade receivable in PEB's case? thanks for help

I would say so ... and so it appears otherwise things don't make sense.

That Aust thing snaps pointed out is only recognised on a 'Cash' basis so wouldn't appear in Receivables

[psychic]

Cheers. No creative way of thinking it might be CMS sales then?

[winner69]

Cheers. No creative way of thinking it might be CMS sales then?

They may have decided not to recognise these sales at all (like saying no certainty about getting paid or something)

But generally if recognised they go against revenues / offset is trade receivables. Trade receivables reduced when cash actually received.

But then again some company do tricky things but PEB don't appear to

[skid]

im not a whiz at accounting ,but in terms of assessing their performance-what is the bottom line (without grants) and what % would it work out to compared to their cap raising -For Barr etc. predictions?
(I would kind of consider grants a freebie in terms of performance)(good for potential but not as a gauge at how they are selling the product)

I stand to be corrected if Im wrong--cheers

[psychic]

They may have decided not to recognise these sales at all (like saying no certainty about getting paid or something)

But generally if recognised they go against revenues / offset is trade receivables. Trade receivables reduced when cash actually received.

But then again some company do tricky things but PEB don't appear to

Thanks. Just wondering if they might say, not include CMS sales in Revenue, but perhaps include as Trade Receivable - as a future offset against Development costs once collected (ie costs incurred establishing the CMS relationship)

Long shot but...

[winner69]

Just for you psychic - how PEB recognise revenue

(l) Revenue Recognition

Revenue is measured at the fair value of the consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts collected on behalf of third parties.

The Group recognises revenue when the amount of revenue can be reliably measured, it is probable that future economic benefits will flow to the entity and specific criteria have been met for each of the Group’s activities as described below.

Operating revenues represent the revenue from the sale of goods that is recognised when a group entity sells a product to the customer.

Consultancy fees are recognised in the accounting period in which the services are rendered. For fixed- price contracts, revenue is recognised under the percentage of completion method, based on the actual service provided as a proportion of the total services to be provided.

Grants from the government are recognised at their fair value where there is a reasonable assurance that the grant will be received and the Group will comply with all attached conditions. Government grants relating to costs are deferred and recognised in the profit or loss over the period necessary to match them with the costs that they are intended to compensate. Grants are for reimbursement of laboratory costs.

Cxbladder research rebate is recognised at its fair value where there is a reasonable assurance that the rebate will be received and the Group will comply with all attached conditions. Due to the time taken between submission of the rebate claim and the receipt of funds, this revenue is recognised on a cash basis in accordance with NZ IAS 18. The Cxbladder research rebate is for the research programme administered by Pacific Edge PTY Limited.

Interest income is recognised using the effective interest method. When a receivable is impaired, the Group reduces the carrying amount to its recoverable amount, being the estimated future cash flow dis- counted at the original effective interest rate of the instrument, and continues unwinding the discount as interest income. Interest income on impaired loans is recognised using the original effective interest rate.

[psychic]

I should have found this, thanks.
Oh well. Back to guessing re CMS then..

[Minerbarejet]

Given the figure 3 for last years hy and 236 as an average of Hancocks figures for the full year 14 , if that rate of climb has continued
It projects to 4456 to end of Sept this Hy and you guessed it " several tens of thousands", like 8, ​by march FY 15

[psychic]

Given the figure 3 for last years hy and 236 as an average of Hancocks figures for the full year 14 , if that rate of climb has continued
It projects to 4456 to end of Sept this Hy and you guessed it " several tens of thousands", like 8, ​by march FY 15

Lol - yes , not that they said tens of thousands though, emphatically denied, but if they had, they were meaning (but not saying) several tens of thousands of tests - not just sales, Must have been a lot of tests run under the user prog's that will not be included..

[klid]

Whoops--guess I shouldnt have used you as an example(must have been on previous trades)--but the point is still the same --I would venture to say you would be farther in the hole if you would have done nothing?

Actually $6,100 down now at $0.79. If I did nothing I would have 25,000 @ $1.20 ($30,000) currently worth $19,750 so would be down $10,250. So the couple of trades and the waiting for the last month helped a bit.

Umm, so now I am holding I am pleased to see it not close below 78 although volume wise it traded under 78 (just - about 0.777) all day today AND yesterday.

But there are signs now I think that it's not going to blatantly drop more on no news. Hard to decide such things, so many factors and all.

Has anyone else noticed that for the first time in... a long time, the numbers of shares on the buy and sell side have started to even up. And there's a big chunk there for sale at $0.85.


Now... on the topic of sales! I don't care about anything other than the cxbadder sales, which will be amongst trading revenue, but they'll be reported separately and will be my #1 focus of the report.
For the year ended March 2012 they had $9,615 worth of sales. A handful of sold tests.
2013 - $15,022, again, a handful.
2014 - $145,195 worth of tests sold - MORE than a handful. And almost 10x on the last year (don't pay much attention to that as they were so miniscule last year).

There are some facts, so what would you expect so see in the way of trading revenue, or actually, just cxbladder sales, for this half year.
One thing I can tell you, is that if it is UNDER $150,000, which is what 250-300 tests -- that is really bad, and I would be selling quick smart.

[klid]

Actually, I am not so sure that they will release amount of cxbladder sales in the half, does anyone know?

I can't find last years report. NZX are so useless compared to ASX. Go to their website and you can find the quarterly report for a run down company from back in 2007 in a matter of seconds. God they piss me off. Would never buy NZX.

https://nzx.com/companies/PEB/announcements/244534
Yeah would be nice if there was the report attached to it.

[Minerbarejet]

PEB website should have it.

[skid]

Actually $6,100 down now at $0.79. If I did nothing I would have 25,000 @ $1.20 ($30,000) currently worth $19,750 so would be down $10,250. So the couple of trades and the waiting for the last month helped a bit.

Umm, so now I am holding I am pleased to see it not close below 78 although volume wise it traded under 78 (just - about 0.777) all day today AND yesterday.

But there are signs now I think that it's not going to blatantly drop more on no news. Hard to decide such things, so many factors and all.

Has anyone else noticed that for the first time in... a long time, the numbers of shares on the buy and sell side have started to even up. And there's a big chunk there for sale at $0.85.


Now... on the topic of sales! I don't care about anything other than the cxbadder sales, which will be amongst trading revenue, but they'll be reported separately and will be my #1 focus of the report.
For the year ended March 2012 they had $9,615 worth of sales. A handful of sold tests.
2013 - $15,022, again, a handful.
2014 - $145,195 worth of tests sold - MORE than a handful. And almost 10x on the last year (don't pay much attention to that as they were so miniscule last year).

There are some facts, so what would you expect so see in the way of trading revenue, or actually, just cxbladder sales, for this half year.
One thing I can tell you, is that if it is UNDER $150,000, which is what 250-300 tests -- that is really bad, and I would be selling quick smart.

Im still trying to figure out how it dropped to where it is now on no news--I would have thought it would have been in a holding pattern till sales release.

that chunk @ 85 was sitting there yesterday as well--not sure when it started.

In terms of trading below 77-78 its looking like the resistance is holding (you may want to ask hoop for more experienced details in that arena.

[skid]

Given the figure 3 for last years hy and 236 as an average of Hancocks figures for the full year 14 , if that rate of climb has continued
It projects to 4456 to end of Sept this Hy and you guessed it " several tens of thousands", like 8, ​by march FY 15

Thats a bit of a scarey scenario.
Given posters guesses,does any one think thats achievable?

[BFG]

Actually, I am not so sure that they will release amount of cxbladder sales in the half, does anyone know?

I can't find last years report. NZX are so useless compared to ASX. Go to their website and you can find the quarterly report for a run down company from back in 2007 in a matter of seconds. God they piss me off. Would never buy NZX.

https://nzx.com/companies/PEB/announcements/244534
Yeah would be nice if there was the report attached to it.

Klid, you can easily extrapolate the number of tests sold by digging a bit deeper into the audited numbers (yes, they like hiding the number of paid tests and you have to do it yourself by assuming rough numbers! Red flag much?). A lot of companies like to just state botoom lines and try to flash them up in the hope the majority of people won't dig any deeper.

Be good to compare how many tests they have freebied/paid for themselves vs how many they have actually sold. I doubt this will be possible though (see above). My thought are the former will be multiples higher than the latter.

Looks like a ship is sailing out of Harbour these days...

[twotic]

Quick question: Did Edison provide the update required to fix their balz up in their PEB analysis? I've not been keeping a close eye on that one, but noticed quite a few people mentioning their indicative SP range. Maybe they fixed things up?

[MAC]

Quick question: Did Edison provide the update required to fix their balz up in their PEB analysis? I've not been keeping a close eye on that one, but noticed quite a few people mentioning their indicative SP range. Maybe they fixed things up?

Looks like they have Twotic, http://www.edisoninvestmentresearch.com/research/company/pacific-edge

Makes, their valuation range now $0.42 to $3.57

From present SP that’s, -47.5% to +346%, just a little more upside than not.

[winner69]

Looks like they have Twotic, http://www.edisoninvestmentresearch.com/research/company/pacific-edge

Makes, their valuation range now $0.42 to $3.57

From present SP that’s, -47.5% to +346%, just a little more upside than not.

What a hoot ....even half way isv$2.00

Mines even more of a hoot ......range 65 cents to 95 cents

[twotic]

Looks like they have Twotic, http://www.edisoninvestmentresearch.com/research/company/pacific-edge

Makes, their valuation range now $0.42 to $3.57

From present SP that’s, -47.5% to +346%, just a little more upside than not.

Cool thanks!

As a largely irrelevant aside, when I contacted one of Edinson's analysts to ask for the source of some of their info, the analyst very confidently replied they came from conversations with CEO Donald Darlington (or something similar) ;) I had a quiet chuckle.

[MAC]

Of course the interesting thing about that Edison valuation range, $0.42 to $3.57, is the two key sensitivity analysis variables giving rise to it, “price point”, and, “market penetration”.

Want to know how Pacific Edge are doing, and where to place them in that range from the pending report ?

1. Then look for an indication of present price point beyond the $550 per test proposed by Pacific Edge in 2011, noting that both Forbar and Edison expect it to rise over the next few years, and,

2. Assess progress against plan for market penetration in 2019, and a reaffirmation of the five year goal.

And no, for the cynical and FA challenged, very early sales at FY15 do not tell you anything about the ultimate market penetration potential. The pending sales figure matters bugger all.

“Our sensitivity analysis suggests a value range of NZ$0.42-3.57/share depending on price and penetration in the US; in our base case we assume pricing of US$650 and 10% market penetration for Cxbladderdetect. Pacific Edge is at the start of the commercial roll-out and, as such, there is still considerable uncertainty as to the full sales potential in the coming years. We consider the chief variables are the level of market penetration that can be achieved, particularly in the US, and average pricing. Our base case is on the conservative side in both regards, therefore we expect significant upside potential on our forecasts if Pacific Edge’s performance exceeds our cautious expectations”

[skid]

Of course the interesting thing about that Edison valuation range, $0.42 to $3.57, is the two key sensitivity analysis variables giving rise to it, “price point”, and, “market penetration”.

Want to know how Pacific Edge are doing, and where to place them in that range from the pending report ?

1. Then look for an indication of present price point beyond the $550 per test proposed by Pacific Edge in 2011, noting that both Forbar and Edison expect it to rise over the next few years, and,

2. Assess progress against plan for market penetration in 2019, and a reaffirmation of the five year goal.

And no, for the cynical and FA challenged, very early sales at FY15 do not tell you anything about the ultimate market penetration potential. The pending sales figure matters bugger all.

“Our sensitivity analysis suggests a value range of NZ$0.42-3.57/share depending on price and penetration in the US; in our base case we assume pricing of US$650 and 10% market penetration for Cxbladderdetect. Pacific Edge is at the start of the commercial roll-out and, as such, there is still considerable uncertainty as to the full sales potential in the coming years. We consider the chief variables are the level of market penetration that can be achieved, particularly in the US, and average pricing. Our base case is on the conservative side in both regards, therefore we expect significant upside potential on our forecasts if Pacific Edge’s performance exceeds our cautious expectations”

Your actually placing your faith in an outfit that has rated a co. at somewhere between .42-3.57 which they established by talking to the CEO of that co??(and got important facts wrong to boot?)--They might as well said --They are going to do better or worse(or maybe stay the same)

Why would the price rise?(If it happens that they are not making enough sales-then perhaps the price should drop)

Market penetration--Thats gauged by the sales (that you say are unimportant)--I would venture to say the market will disagree with you if thats the case.

[skid]

One week out from sales report--I challenge anyone to dispute the fact that the sales will not have a noticeable impact on the SP one way or the other--just for the record.

[MAC]

Not at all, I do my own analysis, thanks very much, although I don't disagree with Edison's findings as I've replicated them to my satisfaction.

All pre-profitable companies have market parameters yet to be confirmed, nothing new about that, sensitivity analysis is not new either as an investor’s tool for measuring valuation ranges.

What one must note about the Edison $0.42 to $3.57 valuation range is thus;

“Based on progress to date in the US market, Pacific Edge management’s target of Pacific Edge NZ$100m in sales by FY19 for the group looks attainable. However, we err on the side of caution and model revenue of NZ$100m two years later in FY21”

The goal of Pacific Edge is $100M in revenues by 2019. The Edison valuation range is based on a later 2021 outturn.

Also of note is that they have not yet included the value of the melanoma and colorectal products.

“We do not include additional pipeline products in our forecasts. We forecast sales into the US, New Zealand and Australia only and do not include added value for the technology of the company”

[twotic]

Your actually placing your faith in an outfit that has rated a co. at somewhere between .42-3.57 which they established by talking to the CEO of that co??(and got important facts wrong to boot?)--They might as well said --They are going to do better or worse(or maybe stay the same)

Why would the price rise?(If it happens that they are not making enough sales-then perhaps the price should drop)

Market penetration--Thats gauged by the sales (that you say are unimportant)--I would venture to say the market will disagree with you if thats the case.

Botch ups aside the remainder of their empirical analysis looks pretty sound.

The indicative range is probably fair given the uncertainty that exists - you just have to put some of it in context.

One thing I feel that would have been prudent is extending the sensitivity analysis to include lower values of the test price. IF KP entertain the idea of CxBladder I suspect they will negotiate a reduced price.

Other than that the Edison report looks reasonable - IMO the key is to be aware of the risk, determine the probability of those risks for yourself, revise the likelihood of the SPs within the indicative range and possibly the range itself, and of course understand Edison is being paid to write the report and put their SP target and all else in context.

[winner69]

not so sure about the range being fair......given the risk and uncertainty and sales performance to date me thinks 0-$3.57 is a better indication

Started reading that and thought you were going to $0 to $1

[BFG]

One week out from sales report--I challenge anyone to dispute the fact that the sales will not have a noticeable impact on the SP one way or the other--just for the record.

*Wonders if MAC is willing to take up the challenge...*

[Balance]

One week out from sales report--I challenge anyone to dispute the fact that the sales will not have a noticeable impact on the SP one way or the other--just for the record.

How is it possible to tell?

Unless the sales numbers are released first day, and then progress commentary next day?

[klid]

:) Balance Yes true, how to differentiate... How would you know the balance of the two as far as impact to SP.
But if the commentary is what Miner posted before... repeating the same old stuff without too much new info - which I entirely expect it will be, then you can make some educated conclusions/guesses I think.

In reply to KP... If KP wanted a reduced price I would tell them to go jump in a lake, hopefully so would the major shareholders and board. I really don't think they would try anything stupid like that. Not worried.

[twotic]

:) Balance Yes true, how to differentiate... How would you know the balance of the two as far as impact to SP.
But if the commentary is what Miner posted before... repeating the same old stuff without too much new info - which I entirely expect it will be, then you can make some educated conclusions/guesses I think.

In reply to KP... If KP wanted a reduced price I would tell them to go jump in a lake, hopefully so would the major shareholders and board. I really don't think they would try anything stupid like that. Not worried.

Are you serious? Given the circumstances, KP would be stupid not to negotiate a cheaper price. Would you mind explaining why you think it would be stupid for KP to attempt to contract a cheaper price? I'm struggling to think of any reasonable rationale.

[skid]

Botch ups aside the remainder of their empirical analysis looks pretty sound.


The indicative range is probably fair given the uncertainty that exists - you just have to put some of it in context.

One thing I feel that would have been prudent is extending the sensitivity analysis to include lower values of the test price. IF KP entertain the idea of CxBladder I suspect they will negotiate a reduced price.

Other than that the Edison report looks reasonable - IMO the key is to be aware of the risk, determine the probability of those risks for yourself, revise the likelihood of the SPs within the indicative range and possibly the range itself, and of course understand Edison is being paid to write the report and put their SP target and all else in context.

Id imagine anyone negotiating a so called bulk order would do so at a reduced rate--bigger quantity-reduced rate per test--its one of the basic laws of economy--but thats not so much the issue--Its getting that bulk order in the first place that is more the issue.(and when)
If sales are up to scratch this time--then no worries.--If not ,then we are left wondering when they will pick up--I dont want to put the cart before the horse because they may be good--but as we know ,the market is not fond of uncertainty so IMO sales is an issue.
It was an issue last time ,and will always be an issue--Thats not to say if they are not so good,the company is going to fold up and cease to exist--just means more volatility.

So edison has revised their prediction of 100mil to 2021(to be on the safe side?) Soon we will find out where we are on that rd. to 100mil.

[skid]

The point in Pacific edge agreeing to a separate pricing agreement could be that KP MAY be the first or only outfit to agree to a bulk order.

[MAC]

It works like this, per diagram below, the NPN agreements set the market price, probably reviewed annually, Pacific Edge already have four NPN’s on board so far, FedMed, ACPN, Stratose, and Multiplan, together providing a standing price agreement for 68M Americans who are covered by insurance companies associated with those NPN’s.

It’s just my speculation too, but in the case of some HMO’s like KP who have a very high proportion of in-house medical facilities, 109 urologists, 700 oncologists and 38 or their own hospitals, it is possible that a separate price agreement may be struck.

However, there would be no point in Pacific Edge agreeing to a separate pricing agreement with KP unless a it is for an exclusive agreement.

Even then Pacific Edge may retain price point floor at NPN level, and/or link it under review annually, Cxbladder after all is the best clinically performing test in the market place, and urologists will want it, supply and demand and all that.

The Cxbladder value propositions also offer substantial commercial savings more so than competing products can, and a company like KP will be doing very well indeed just in securing an agreement with Pacific Edge and in realising those savings.

This may be particularly so within an in-house clinical setting where scales of economy based around a Cxbladder policy would also be probably quite attractive.

6490

[twotic]

It works like this, per diagram below, the NPN agreements set the market price, probably reviewed annually, Pacific Edge already have four NPN’s on board so far, FedMed, ACPN, Stratose, and Multiplan, together providing a standing price agreement for 68M Americans who are covered by insurance companies associated with those NPN’s.

It’s just my speculation too, but in the case of some HMO’s like KP who have a very high proportion of in-house medical facilities, 109 urologists, 700 oncologists and 38 or their own hospitals, it is possible that a separate price agreement may be struck.

However, there would be no point in Pacific Edge agreeing to a separate pricing agreement with KP unless a it is for an exclusive agreement.

Even then Pacific Edge may retain price point floor at NPN level, and/or link it under review annually, Cxbladder after all is the best clinically performing test in the market place, and urologists will want it, supply and demand and all that.

The Cxbladder value propositions also offer substantial commercial savings more so than competing products can, and a company like KP will be doing very well indeed just in securing an agreement with Pacific Edge and in realising those savings.

This may be particularly so within an in-house clinical setting where scales of economy based around a Cxbladder policy would also be probably quite attractive.

6490
Cheers Mac, has there been confirmation on what those agreed prices are?

[psychic]

Wouldn't stress about the bulk deal discounting concept, the trial with KP is a win/ win situation, and certainly not some last ditch desperate attempt by PEB to flog off tests.

www.mayoclinicproceedings.org/pb/assets/raw/Health%20Advance/journals/jmcp/jmcp_pr88_1.pdf

Rochester, MN, January 9, 2013 – Microscopic amounts of blood in urine have been considered a risk
factor for urinary tract malignant tumors. However, only a small proportion of patients referred for
investigation are subsequently found to have cancer. A new Kaiser Permanente Southern California study
published in the February Mayo Clinic Proceedings reports on the development and testing of a
Hematuria Risk Index to predict cancer risk. This could potentially lead to significant reductions in the
number of unnecessary evaluations.

So where the Urologists may be slow to adapt (let's face it, there is money to be made in unnecessary evaluations right?), KP with it's extensive resources can drive change, and will do if to save cost and lives.

[klid]

Are you serious? Given the circumstances, KP would be stupid not to negotiate a cheaper price. Would you mind explaining why you think it would be stupid for KP to attempt to contract a cheaper price? I'm struggling to think of any reasonable rationale.

I'd be disappointed. The test is already cheap. If anything the price should go up. Don't want them to set precedents. I don't like pussy lawyers and I sure don't like pussy companies! They always fail.
They can have the tests cheaper if they lump sum give us say $2m.

[robbo24]

I'd be disappointed. The test is already cheap. If anything the price should go up. Don't want them to set precedents. I don't like pussy, lawyers and I sure don't like pussy companies! They always fail.
They can have the tests cheaper if they lump sum give us say $2m.

Improve your grammar, please.

[MAC]

I think Twotic those NPN price points would undoubtedly be confidential I’m sure, wouldn’t you agree.

Edison though are using $650 per sale for 2014 and 2015 within their analysis, given they prepare their reports independently, and then run them by their clients for comment on data accuracy, that may well be a fair representation.

Note though, that’s probably what Pacific Edge are receiving per test, either all or some of that may come from the insurer under an NPN agreement, any balance may come directly from the patient as co-pay. So, the NPN price point(s) may also be $650 or they may be a small percentage lower.

The same may well apply to a prospective exclusive KP agreement.

Pacific Edge may agree a price point with KP, however KM members may still have to contribute a co-pay to make up the difference to the $650 that Pacific edge ultimately receive for each test.

The Cxbladder billing policy is here: http://www.cxbladder.com/for-patients/billing-policy/

“Pacific Edge will bill the patient’s insurance for Cxbladder. Patient financial responsibility will be determined by the patient’s health plan coverage of Cxbladder to include appropriate co-pay, deductable, and/or co-insurance. As required by law, patients are responsible for all copays and deductibles as defined by their insurance company”

Edison report (http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799): http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799 (http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799)

[klid]

Improve your grammar, please.

LOL, I was about to say, what grammar, but I get your joke :) Good one.

[psychic]

https://www.nzx.com/companies/PEB/announcements/257934

Pacific Edge advises that it intends to release its 2015 interim financial results for the six months ending 30 September 2014, on Friday 28 November 2014 prior to 10am.

:)

[Minerbarejet]

Good old NZX.
PEB to announce FY 2015 results on 28th Nov 2014.
That could be interesting six months ahead.:)
Future must be looking really good!:)

In the interim they have found interim. Thats better:)

[skid]

Well we have a firm D day(as many expected -28th)--Is anyone going to bother having a look? (wouldnt want to be seen to be on the edge of our seats now would we?:):)

[couta1]

TE=skid;517865]Well we have a firm D day(as many expected -28th)--Is anyone going to bother having a look? (wouldnt want to be seen to be on the edge of our seats now would we?:):)[/QUOTE]
Dont worry a quick glance at this thread shortly after 10am and we will know by the presense or absense of droves of Trolls and Knockers:cool:

[skid]

TE=skid;517865]Well we have a firm D day(as many expected -28th)--Is anyone going to bother having a look? (wouldnt want to be seen to be on the edge of our seats now would we?:):)
Dont worry a quick glance at this thread shortly after 10am and we will know by the presense or absense of droves of Trolls and Knockers:cool:[/QUOTE]

And how about you Couts -will you be here?

Just for fun consider this---A long term holder generally holds long term and maybe checks in once in a great while as daily movements are not really relevant --He/she are in for the long haul

A trader doesnt bother with chat as he /she determines their investment decisions based on the charts--therefore the chat is irrelevant

So where does that leave Us??

[skid]

TE=skid;517865]Well we have a firm D day(as many expected -28th)--Is anyone going to bother having a look? (wouldnt want to be seen to be on the edge of our seats now would we?:):)
Dont worry a quick glance at this thread shortly after 10am and we will know by the presense or absense of droves of Trolls and Knockers:cool:[/QUOTE]

And just to be clear-i certainly hav'nt ruled out that the announcement might be positive and the SP will follow--But at the same time Im realistic enough to know that whatever the result--it will have an affect on the SP and we are clearly still in very speculative territory-regardless of any opinions that pretend to believe otherwise

[klid]

We're a cent up. Some high roller took 500 @ $0.83. $0.82 has some on it's side now :)
For the first time in ages I can see $1.00 10th place on the sell side!

[craic]

Trolls and Knockers? - I just come here for a laugh sometimes. But it's more fun on the other channel where the Labour Party faithfully continue to convince us that pigs can fly.

[skid]

Trolls and Knockers? - I just come here for a laugh sometimes. But it's more fun on the other channel where the Labour Party faithfully continue to convince us that pigs can fly.

Quote of the week has to have come from John Key though--When asked about trading with China with their human rights abuses and ONE PARTY SYSTEM
he replied ''Ill leave that to the Chinese people,they can decide for themselves'' :confused:

[klid]

Bought at $0.77. Might add more to it depending on price/results.

Sold at ~$0.82. Remainders at $0.80 dropping the price to that.
Pretty 50/50 decision. Dunno whether it was the good one, might buy again soon.

[steve06]

was doing some catch up reading last night, came across this http://effectivehealthcare.ahrq.gov/ehc/products/571/1941/bladder-cancer-non-muscle-invasive-protocol-140721.pdf

looks like Cxbladder has a few more competitors than I thought (There are five diagnostic biomarker tests approved by the FDA for diagnosis or surveillance of bladder cancer: BTAstat® (BTA), Alere NMP22®, BladderChek® (NMP22), UroVysion® (FISH) and ImmunoCyt™), does anyone know how extensive these tests are used in the US, or how well performance wise these tests are?

[steve06]

Been hectic with work and other commitments so haven't had the time to do more in-depth research...

[psychic]

was doing some catch up reading last night, came across this http://effectivehealthcare.ahrq.gov/ehc/products/571/1941/bladder-cancer-non-muscle-invasive-protocol-140721.pdf

looks like Cxbladder has a few more competitors than I thought (There are five diagnostic biomarker tests approved by the FDA for diagnosis or surveillance of bladder cancer: BTAstat® (BTA), Alere NMP22®, BladderChek® (NMP22), UroVysion® (FISH) and ImmunoCyt™), does anyone know how extensive these tests are used in the US, or how well performance wise these tests are?


The Edison report provides an overview:

http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799

[Crystal Ball]

was doing some catch up reading last night, came across this http://effectivehealthcare.ahrq.gov/ehc/products/571/1941/bladder-cancer-non-muscle-invasive-protocol-140721.pdf

looks like Cxbladder has a few more competitors than I thought (There are five diagnostic biomarker tests approved by the FDA for diagnosis or surveillance of bladder cancer: BTAstat® (BTA), Alere NMP22®, BladderChek® (NMP22), UroVysion® (FISH) and ImmunoCyt™), does anyone know how extensive these tests are used in the US, or how well performance wise these tests are?
Hi steve06, according to the Edison report, yes there are several other companies in the melting pot however Pacific Edge in their words have a leg up on the opposition in that they are far more ahead and advanced than their competitors....

[Crystal Ball]

was doing some catch up reading last night, came across this http://effectivehealthcare.ahrq.gov/ehc/products/571/1941/bladder-cancer-non-muscle-invasive-protocol-140721.pdf

looks like Cxbladder has a few more competitors than I thought (There are five diagnostic biomarker tests approved by the FDA for diagnosis or surveillance of bladder cancer: BTAstat® (BTA), Alere NMP22®, BladderChek® (NMP22), UroVysion® (FISH) and ImmunoCyt™), does anyone know how extensive these tests are used in the US, or how well performance wise these tests are?
Hi steve06, according to the Edison report, yes there are several other companies in the melting pot however Pacific Edge in their words have a leg up on the opposition in that they are far more ahead and advanced than their competitors....

[steve06]

I've come across these two (mid to small sized) studies previously, carried out in Australiasia?, have they recently completed studies of regional US populations or representative US populations? As gene variances are found across populations, different races of people, regions etc, one test which proves useful in one population might not be so useful in another...

[skid]

Another question may be -have any of the tests that have been around for a while been successful?(if one product has been successful-then it stands to reason that another better one, would be MORE successful--But if none have been successful,then it is an unproven market.

[skid]

Sold at ~$0.82. Remainders at $0.80 dropping the price to that.
Pretty 50/50 decision. Dunno whether it was the good one, might buy again soon.

You are being very prudent Klid which is commendable(a bird in the hand,and all that)

Here's a quote from a pretty clued in poster(IMO)

Buying stocks is easy. Its the selling of them thats hard! The toughest lesson to learn is when to sell a share (goes on to explain how dangerous it is when a share's 50day moving average is below the 200 day ma---all about uptrends and downtrends)

[psychic]

I've come across these two (mid to small sized) studies previously, carried out in Australiasia?, have they recently completed studies of regional US populations or representative US populations? As gene variances are found across populations, different races of people, regions etc, one test which proves useful in one population might not be so useful in another...

It's a good question Steve06 and I don't know if it has been discussed here. My understanding is that CxBladder identifies changes in gene expression (5 markers) and so useful across the board. Is it the genetic propensity to develop Bladder Cancer that may vary? Hopefully Hancocks or someone better informed will let us know.


cheers

[psychic]

Another question may be -have any of the tests that have been around for a while been successful?(if one product has been successful-then it stands to reason that another better one, would be MORE successful--But if none have been successful,then it is an unproven market.

Yes they are, and big money is involved.They have been adopted in practice but fall short on performance

[steve06]

It would all come down to how successful results from US studies are as to the adoption or not of the product, due to regional, population differences, etc mentioned above. Hadn't been closely following PEB since I sold out to go on my OE last year. Just been recently doing some catch-up, have they completed any US studies recently? Will have to dig deeper in the weekend and hopefully find something.

[psychic]

Yes, it would certainly put a dent in the works if US studies did not confirm the results...:eek2:

Edit: I'd hope that an oversight by PEB of the proportions you suggest is highly unlikely..) :)

Understand they are awaiting data from two US and two Aus studies. These will be combined with the NZ results and blinded DHB results and published soon.

[steve06]

Any indication on when the results of these studies will be published? Will await the results of these studies with interest.

[Minerbarejet]

Why the announcement for an announcement? Its even posted on the website. My guess is it is to prevent endless speculation as to whether it may be a couple of days early like last time. Even so, they have never done it before and have possibly set a precedent for themselves.

[skid]

Why the announcement for an announcement? Its even posted on the website. My guess is it is to prevent endless speculation as to whether it may be a couple of days early like last time. Even so, they have never done it before and have possibly set a precedent for themselves.

They probably learned their lesson last time as some would have been aggravated by not having sufficient warning--Most reputable companies have a firm reporting date which is standard practice.
A bit more info would also be appreciated.No ones is expecting sensitive information,but a bit more of a clue on keeping shareholders up to date is good practice(with the exception of Chris:))

[twotic]

Yes, it would certainly put a dent in the works if US studies did not confirm the results...:eek2:

Edit: I'd hope that an oversight by PEB of the proportions you suggest is highly unlikely..) :)

Understand they are awaiting data from two US and two Aus studies. These will be combined with the NZ results and blinded DHB results and published soon.

This multi-centre publication is very good news for PEB, and seriously needed (as per the AHRQ report).

Psychic, do you know specific details about the 2 OZ studies and the 2 US ones? Where they are being conducted, time frames etc. My only concern with the above is publications take a long time. They need these results sooner rather than later. If these overseas based studies are not complete yet, I'm conceded that this single publication might not be out for a couple years.... If that is the case, surely more frequent publications would be better. You can always cite and quote results from proviso studies.

Any thoughts or additional info you can provide?

Mac, Miner, maybe you can add to the above?

[psychic]

Hey Twotic/ Steve. No, "soon " is all I have sorry.

[MAC]

More studies are definitely a good thing, and that can be read from the AHRQ draft report also.

It’s the 400 patient 24 month Mid Central Health DHB study initiated in June 2013 that will be of interest to the HIH, as it is intended to be more of a commercial evaluation.

“Beginning in June, Mid Central DHB will begin evaluating 400 patients over a 24-month period to determine the clinical utility of Cxbladder to prioritise at-risk patients, and establish the level of savings that can be achieved from screening out patients who do not need a full and expensive urological work up for bladder cancer” https://nzx.com/files/attachments/176047.pdf

Then there was the Queensland user Program to evaluate replacement of ultrasound in a clinical setting with Cxbladder, as far as I’m aware the results have not been published.

And of course there will be a Cxbladder(triage ) study associated with it's product release this year or early next year.

So Psychic, in addition to the above three studies due, it sounds like there may also be a second Australian study underway, and in addition to that two further studies within the US target market also ?

Should find out some more from the HY update I guess, all good.

[MAC]

And here it is, the new website sponsored by Pacific Edge for cancer patients;

“An online community where people affected by bladder cancer can connect with one another, share experiences and support each other in a safe, secure environment”

http://www.bladdercancer.me/
http://www.bladdercancer.me/about_us

[AndyLP]

And here it is, the new website sponsored by Pacific Edge for cancer patients;

“An online community where people affected by bladder cancer can connect with one another, share experiences and support each other in a safe, secure environment”

http://www.bladdercancer.me/
http://www.bladdercancer.me/about_us


Really smart. Big fan

[klid]

And here it is, the new website sponsored by Pacific Edge for cancer patients;

“An online community where people affected by bladder cancer can connect with one another, share experiences and support each other in a safe, secure environment”

http://www.bladdercancer.me/
http://www.bladdercancer.me/about_us

It's cool! How did you find this though, why no announcement. They made two announcements about that other website for direct marketing to NZ (one to tell about it and one on launch).

[okane]

Nice website, but looks like it is not quite finished at the moment. Contact form doesn't work and the Terms & Conditions page still has dummy text. http://www.bladdercancer.me/terms

[Minerbarejet]

Good chance to brushup on some Latin.:)

Not in full swing yet obviously, but a great way to get the message out there.

People in dire straits often turn to the net for help in finding solutions. Having the ability to consult directly online looks like being a very astute, worthwhile and caring approach.

[steve06]

More studies are definitely a good thing, and that can be read from the AHRQ draft report also.

It’s the 400 patient 24 month Mid Central Health DHB study initiated in June 2013 that will be of interest to the HIH, as it is intended to be more of a commercial evaluation.

“Beginning in June, Mid Central DHB will begin evaluating 400 patients over a 24-month period to determine the clinical utility of Cxbladder to prioritise at-risk patients, and establish the level of savings that can be achieved from screening out patients who do not need a full and expensive urological work up for bladder cancer” https://nzx.com/files/attachments/176047.pdf

Then there was the Queensland user Program to evaluate replacement of ultrasound in a clinical setting with Cxbladder, as far as I’m aware the results have not been published.

And of course there will be a Cxbladder(triage ) study associated with it's product release this year or early next year.

So Psychic, in addition to the above three studies due, it sounds like there may also be a second Australian study underway, and in addition to that two further studies within the US target market also ?

Should find out some more from the HY update I guess, all good.


These studies will definitely help in the adoption of CxBladder as it has yet to obtain FDA approval.

[MAC]

These studies will definitely help in the adoption of CxBladder as it has yet to obtain FDA approval.

FDA approval is not presently necessary, US clinicians understand their own health system quite intimately and understand with that knowledge what credentials are and are not required, unlike perhaps those of us in NZ who are not so familiar.

Edison perhaps summarises best everything one needs to know about Cxbladder and FDA.

Edison report (http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799): http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799 (http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799)

“The Cxbladder range is being developed as laboratory-developed tests (LDTs). LDTs are a class of in vitro diagnostic test manufactured, developed and validated for use in a single laboratory.

The CMS (Centers for Medicare and Medicaid Services) regulates clinical laboratories that carry out diagnostic testing through the authority of CLIA (Clinical Laboratory Improvement Amendments), which establishes quality standards for clinical lab testing and a certification programme for labs that perform testing using IVD devices. Under CLIA requirements, the analytical validity of the LDT is evaluated, whereas the FDA’s PMA requirements assess the clinical validity of a test.

The distinction is that analytical validity defines the ability of the test to detect or measure the analytes in question, whereas clinical validity is the ability to accurately diagnose or predict the risk of a particular clinical outcome.

In 2013 Pacific Edge received CLIA regulatory approval for its Hershey, PA laboratory as well as its lab in Dunedin, New Zealand. The company has also received the CAP (College of American Pathologists) signification approval in the US.

Pacific Edge management is currently exploring the pathway to full FDA approval for the Cxbladder portfolio, which would enable the company to directly market to consumers. At this stage CLIA certification is sufficient for direct selling to physicians given the tests are processed in the company’s own lab.

Pacific Edge also faces the potential threat of a new regulatory hurdle in the US. On 31 July 2014 the FDA provided notice of its intent to issue draft guidance providing a risk-based framework for new regulatory requirements of LDTs such as Cxbladderdetect.

In practice the enactment could take time. According to the framework, the new requirements for LDTs are to be phased in over several years. ‘High-risk’ LDTs would be targeted first. We expect Pacific Edge diagnostic tests, such as Cxbladderdetect, would be categorised as Class II (moderate risk). As such, review requirements for Cxbladder tests would begin after the high-risk (Class III) LDTs are completed, which is expected to take five years after the FDA finalises the guidance.

The Class II LDTs would then be reviewed sequentially over a subsequent four-year phase in period. Once reviewed, a product would likely be judged on its safety and would then be required to either follow a formal pre-market approval (PMA) registration process or an optional registration. Given the long notice period, we expect Pacific Edge will have adequate time and resources to prepare for this”

[steve06]

Without FDA approval physicians are unlikely to adopt any test without clinician validation, its good to see PE management seeking FDA approval for the Cxbladder portfolio.

[MAC]

Without FDA approval physicians are unlikely to adopt any test without clinician validation, its good to see PE management seeking FDA approval for the Cxbladder portfolio.

Ummm well no, incorrect, US clinicians are smart very well educated folk who know the difference between FDA and LDT, it's as routine for them as grits and baggles. The only confusion is here in NZ, it would seem, where we struggle a bit sometimes to understand a system we are neither immersed within or familiar with.

Pacific Edge are pursing FDA approval not because they need to, but because their is concurrently a realignment of regulations that may require them to have FDA approval sometime in the future, they have plenty of time to do so, and really don't have a reason to rush into it.

[steve06]

you misunderstood, yes without FDA approval, a CLIA test can still be marketed, to physicians not direct to consumers, however, CLIA approved tests or any other tests are unlikely to be adopted by physicians without clinical validations (user programmes, studies, etc...). FDA approval is a more rigorous, extensive, gold standard to the adoption of any tests or products/drugs, in which clinical validations are a part of.

[MAC]

I don't think you've quite got it yet, FDA approval would be required if Pacific Edge had two or more laboratories within two different states as it is a federal process. FDA approval is not a gold standard, a gold standard is a colloquial term used by urologists, in this context, to describe the mutually adopted policy driven procedures for the detection of bladder cancer, the gold standard is presently cystoscopy.

FDA approval would not be difficult for Pacific Edge to obtain, they have the clinical validations they would need already and have had them for some time now. It can take a couple of years to obtain for some companies if they do not already have completed clinical trials and associated validations, Pacific Edge already have these.

Pacific Edge may pursue direct selling to patients in the US at some point, but for now there seems to be a recognition that it would not be the best use of staff and resources. The big revenues will come from establishing and rolling over user programmes with HMO's, and this is where they are, appropriately allocating resources at present.

[steve06]

I am unfamiliar with the requirements for obtaining FDA approval, however, what does state lines have anything to do with FDA approval? FDA approval is currently is the gold standard (in the US anyway) in the acceptance of tests and drugs.

I am uncertain how far along Pacific Edge is completing its clinical trials and obtaining the necessary validations, but here is a quick overview of the FDA approval process. http://www.fiercebiotech.com/topics/fda_approval_process.asp

[psychic]

Hey Miner, MAC needs the wall. Is it free atm?

[MAC]

PEB completed clinical trials for Cxbladder nearly two years ago now Steve.

Once again the gold standard is cystoscopy, although if you are referring more generically to an all encompassing type of regulatory requirement, then you must note that there are several paths a company can take.

FDA approval is one such path a company like Pacific Edge could take as a molecular diagnostic test provider, another such path is achieving CLIA approval as an LDT. There are many diagnostic test companies in the US that achieve CLIA approvals for their diagnostic test products, it is not unique to Pacific Edge.

Some of Pacific Edge's competitors do require FDA approval as they have one of the following attributes, they either have laboratories in more than one state, sell directly to patients, or they offer a self home test such as NMP22 bladdercheck.

Pacific Edge do not fall into any such category requiring FDA approval, I guess it may even be that the FDA might even turn them away if they did apply simply because the FDA have better things to do then expend effort and cost on approvals that are not necessary.

Hope this helps.

[steve06]

Hi Hancocks and MAC, yes I understand clinical trials/validations such as the DHB studies currently being carried out by MidCentral DHB and user programmes are sufficient for CLIA approved tests. FDA approval would certainly be a big plus.

Will await the the results of these studies with great interest. Cheers.

[klid]

Dave says he's all about "adding meat on the bone" and I see FDA approval as doing just that, so I hope it's something they're seriously pursuing.
And the FDA were trying to extend their jurisdiction to LDTs and such a while ago if I remember correctly, so it's just another thing that could go wrong.

Get get get.

Oh I just read MACs quote of PEB referring to it (good that they did I guess):


Pacific Edge also faces the potential threat of a new regulatory hurdle in the US. On 31 July 2014 the FDA provided notice of its intent to issue draft guidance providing a risk-based framework for new regulatory requirements of LDTs such as Cxbladderdetect.

[steve06]

Haha nice one!

"the only part of the test that needs FDA approval is the collection container and instructions if it is to be used at home."

[Minerbarejet]

Hey Miner, MAC needs the wall. Is it free atm?Sorry, havent finished repairing it. Got a headache.

[skid]

Sorry to say,the more you guys talk about this CLIA vs FDA-the more doubts arise.
Clearly the CLIA is the poor cousin to FDA approval.
They are sending out kits to customers over here so why not in the States? You guessed it-no FDA approval(yet)
Just the fact they dont have it, shows that its a ''small time,one state operation''
The fact they are going after FDA approval shows this,and thats good,but lets not kid ourselves -theres a reason they are doing this--IMO those ''clued in clinicians'' still look for that badge of honor,if for no other reason than it shows this is an outfit that is going places--that means ''states'' ,not ''state''

[psychic]

OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?

[Minerbarejet]

Its called shifting the goalposts.

[MAC]

OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?

Yep, well that’s the plan, get an initial 10% market share from the big professional players without needing to peddle directly with FDA paper work and an army of cheesy foot in the door sales folk.

Might be something for several years from now though, maybe if they get absolutely so much market share they may just want to mop up the rest with direct sales, probably more likely due to regulatory consolidation though.

[skid]

OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?

They are thinking right--They are going after FDA approval----They are not fooling themselves that anything less is suffice--Its us that may have to adjust our thinking--but if it helps--YEA PEB!!!
Howzat:):) (only 4 more days and all will be richhhhhhhhh! )

[psychic]

They are thinking right--They are going after FDA approval----They are not fooling themselves that anything less is suffice--Its us that may have to adjust our thinking--but if it helps--YEA PEB!!!
Howzat:):) (only 4 more days and all will be richhhhhhhhh! )

Sorry, I was being sarcastic Skid. Never works. My point was that PEB actually have a pretty good grasp of the hurdles they need to cross. If it had been important to obtain FDA approval at this stage, they would have done something about it. Have a little faith. They have not gone to the US with the plan of flogging these tests off on ebay.

[steve06]

Here is an article and a site providing more insight into CLIA approved tests and reasons for FDA approval.

http://news.sciencemag.org/health/2014/09/fda-defends-plan-regulate-lab-developed-tests

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf

[psychic]

Here is an article and a site providing more insight into CLIA approved tests and reasons for FDA approval.

http://news.sciencemag.org/health/2014/09/fda-defends-plan-regulate-lab-developed-tests

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf

So you understand and agree with MAC now?

[skid]

FROM the 1st article....
. Although CLIA ensures that labs perform a test properly, it doesn’t address the clinical validity of the test itself—how accurately it measures a patient’s condition. “We have a responsibility to provide patients with greater certainty,” Shuren said.

And it goes on to talk about how the FDA may regulate some of the tests

CLIA test may be ok'd--but FDA approved they aint (not yet)

[psychic]

FROM the 1st article....
. Although CLIA ensures that labs perform a test properly, it doesn’t address the clinical validity of the test itself—how accurately it measures a patient’s condition. “We have a responsibility to provide patients with greater certainty,” Shuren said.

And it goes on to talk about how the FDA may regulate some of the tests

CLIA test may be ok'd--but FDA approved they aint (not yet)


Correct. And for the last time, they have not needed FDA approval thus far. It has not been an impediment. The US Urologists understand LDT's.
Yes, the FDA may regulate - may even take them 9 years...
MAC has gone over this. It will happen when needed but it is not something that need concern us now,

[MAC]

Well, because you know so much more than the experienced within market Pacific Edge CEO and executive sales staff, and because you know so much more than the internationally recognised Pacific Edge advisory board, then you probably actually think you might even be right.

An LTD process does place the emphasis on the company to demonstrate clinical validity. It offers a complementary approach to the Pacific Edge strategic plan in targeting large health organisations who must assess that validity for themselves as a routine adoption practice.

The customers and prospective customers of Pacific Edge are insurers, HMO’s, NPN’s, CMS, VA, and DHB’s.

Those customers are not lay people in the street, they are experienced health professional managers, and Pacific Edge retain independent clinical trials, studies and user programmes outcomes, with a lot more on the way, as a demonstration of that validity.

And what those mangers see is performance better than any other test in the market place.

[robbo24]

I've got a bet with BFG for a pack of Winnie Blue 20s depending on where PEB ends up at the end of the month.

Low to mid 80s and I win a pack of Winnie Blues.

I don't even smoke but still - Winnie Blues mate.

[steve06]

I am not claiming to be the top expert on all this, nor to know the clinical efficacy of Cxbladder. I am presenting what I know about LDTs and the limitations of CLIA approved tests, which some posters here do not fully understand (CLIA approval affirms test performance, but does not provide clinical validity). We will know with more certainty the clinical efficacy of Cxbladder with the completion of clinical trials and validations in the near future, or possibly in four days time...?

[skid]

Sorry, I was being sarcastic Skid. Never works. My point was that PEB actually have a pretty good grasp of the hurdles they need to cross. If it had been important to obtain FDA approval at this stage, they would have done something about it. Have a little faith. They have not gone to the US with the plan of flogging these tests off on ebay.

I got the sarcasm:)
I was just making the point that sometimes I think we misinterpret what PEB is up to--They are going after FDA approval so they must think its important,but I think it is a time consuming process.(If they were concerned about looking cheesy with foot in the door stuff--they would have not come up with the internet order test they have here)or maybe its ok to be cheesy in NZ but not the States :confused:
I believe that this is going to take more time than some are expecting--Thats not the end of the world,but alot are still looking at this with a gamblers point of view(like they got a taste of before) and I dont think this is the type of product that is going to suddenly fly off the shelves,like some new software that appeals to the wow factor.
Its a tiny minnow in a gigantic sea of medical heavy weights. It will take time and I think those that are expecting the fireworks of before may punish this lag-which,if Im right,will not fit in to this way of thinking.
I may be completely wrong and we will see fireworks,but it may be just a blip along the way.
In some ways I agree with Mac that its just a step in a long process(sales) What I disagree with him is the effect it will have on investors if they are still slow off the blocks.

(just thought I would fill some of the vacume between now and the report this fri:):)

[skid]

Well, because you know so much more than the experienced within market Pacific Edge CEO and executive sales staff, and because you know so much more than the internationally recognised Pacific Edge advisory board, then you probably actually think you might even be right.

An LTD process does place the emphasis on the company to demonstrate clinical validity. It offers a complementary approach to the Pacific Edge strategic plan in targeting large health organisations who must assess that validity for themselves as a routine adoption practice.

The customers and prospective customers of Pacific Edge are insurers, HMO’s, NPN’s, CMS, VA, and DHB’s.

Those customers are not lay people in the street, they are experienced health professional managers, and Pacific Edge retain independent clinical trials, studies and user programmes outcomes, with a lot more on the way, as a demonstration of that validity.

And what those mangers see is performance better than any other test in the market place.

If some of the customers are in this group -insurers,Hmo's,etc--then we should expect to see some results in sales--If they are still prospective--then lets hope they can bring some around..

[MAC]

I am not claiming to be the top expert on all this, nor to know the clinical efficacy of Cxbladder. I am presenting what I know about LDTs and the limitations of CLIA approved tests, which some posters here do not fully understand (CLIA approval affirms test performance, but does not provide clinical validity). We will know with more certainty the clinical efficacy of Cxbladder with the completion of clinical trials and validations in the near future, or possibly in four days time...?

I think you will find if you actually bother to check Steve that clinical trials really were completed nearly two years ago with absolutely exceptional results, and those trial results were independently peer reviewed in 2012 to the satisfaction of those clinicians involved.

What you may also like to consider is the very many successful LDT companies that are operating in the US and have been so for a long time, probably hundreds, routinely and professionally delivering diagnostic tests to the health sector across the entire range of medical disciplines.

But of course, perhaps you are right and all those companies and their professionals are wrong, I don't really think time needs to tell, or perhaps all those companies will now suddenly have to disappear in a puff of sharetrader forum logic.

[BFG]

Forbarr up grading PEB to $1.25 forecast from $1.10. Why they are doing this right before a critical HY report is beyond me. They're either goung to be very right or very wrong very soon!

You been chucking them your spreadsheets then MAC??? :D

[MAC]

Forbarr up grading PEB to $1.25 forecast from $1.10. Why they are doing this right before a critical HY report is beyond me. They're either goung to be very right or very wrong very soon!

You been chucking them your spreadsheets then MAC??? :D


Ha, would be interested in a link if you have one actually.

Given Forbar have taken such a conservative approach thus far with PEB, we should be watching for a series of upgrades over the coming year or two, and they did pretty much tell us that within their report in their own way, but yes I agree there is a risk they might be embarrassed at some point through discounting valuations too much, Morningstar are possibly the best at embarrassing themselves in that way.

[klid]

Forbarr up grading PEB to $1.25 forecast from $1.10. Why they are doing this right before a critical HY report is beyond me. They're either goung to be very right or very wrong very soon!

You been chucking them your spreadsheets then MAC??? :D
Yay inflate the price. :mad ;:

[BFG]

Yay inflate the price. :mad ;:

Haha, first accussed of down ramping/knocking now accussed of ramping it up! Fickle bunch you lot are!

[klid]

Downramp when not holding and ramp up when holding, isnt that how it works? Lol. Nah I want it to stay cheap so I can buy in cheaply.

[BFG]

Downramp when not holding and ramp up when holding, isnt that how it works? Lol. Nah I want it to stay cheap so I can buy in cheaply.

I haven't touched PEB since I last sold @ $1.68, so call me whatever ya like, I ain't it! Just calling it as I see it and trying to keep others informed!

[skid]

Ha, would be interested in a link if you have one actually.

Given Forbar have taken such a conservative approach thus far with PEB, we should be watching for a series of upgrades over the coming year or two, and they did pretty much tell us that within their report in their own way, but yes I agree there is a risk they might be embarrassed at some point through discounting valuations too much, Morningstar are possibly the best at embarrassing themselves in that way.

Would they be embarrassed if they upgraded to much?(as a sidebar to BFGs post about downramping and upramping:) )
They have certainly embarrassed themselves before.......at times. (Forbar)

[MAC]

The only ramping in either direction tends to come from short termers, long termers just don’t care much for sentiment at all really, it’s research and valuation that matters in the long run.

There is plenty of room though within the sensitivity analysis, within the valuation range of the Edison report (http://www.edisoninvestmentresearch.com/?ACT=18&ID=12799), $0.42 to $3.57, for a range of views.

However, when considering analysts valuations one must also consider the level of conservatism provided, Edison have this to say about that valuation range;

“We consider the chief variables are the level of market penetration that can be achieved, particularly in the US, and average pricing. Our base case is on the conservative side in both regards, therefore we expect significant upside potential on our forecasts if Pacific Edge’s performance exceeds our cautious expectations”

Forbar, and with no disrespect to Chelsea who has captured the essence and potential of Pacific Edge very well, tend also to be conservative.

They don’t cover a lot of pre-profitable stocks and they must feel a need to be very conservative in consideration of the interests of their cliental, many of whom do not have the time or FA ability to do their own analysis.

I forsee a lot of upgrades over the next one to two years as that conservatism relaxes. It may even be that Forbar intend to incrementally step-up the expectation of their cliental gradually rather than providing a valuation matched to the goals of Pacific Edge, perhaps that is even best as it assists in taking the volatility out, but for those who do their own work, the opportunity may be more apparent.

[klid]

I haven't touched PEB since I last sold @ $1.68, so call me whatever ya like, I ain't it! Just calling it as I see it and trying to keep others informed!
Sorry I wasnt clear enough. My first comment saying yay the price is getting inflated - with the angry face - was sarcastic... I want it to stay cheap as I do not hold but want to buy back

My second comment was referring to myself. I will be bouyant on this stock if I hold it and will be negative if I do not... because if I had negative sentiment on PEB I would sell and positive I would buy. ☺☺

[steve06]

I think you will find if you actually bother to check Steve that clinical trials really were completed nearly two years ago with absolutely exceptional results, and those trial results were independently peer reviewed in 2012 to the satisfaction of those clinicians involved.

What you may also like to consider is the very many successful LDT companies that are operating in the US and have been so for a long time, probably hundreds, routinely and professionally delivering diagnostic tests to the health sector across the entire range of medical disciplines.

But of course, perhaps you are right and all those companies and their professionals are wrong, I don't really think time needs to tell, or perhaps all those companies will now suddenly have to disappear in a puff of sharetrader forum logic.

You are referring to the 485 patient and 178 patient trials (Journal of Urology, Vol 188, 741-747). Yes they do show test performance much better than comparisons. However, they will not be used as clinical validations for test adoption. That is why DHB studies, user programmes, etc are currently being carried out as steps towards clinical validation and hopefully test adoption, due to a number of factors including differences between populations (gene variances, differences in population composition, social and other environmental factors), physician requirements, other regulatory requirements. Yes LDTs currently do not require FDA approval. However, with the appearances of thousands of LDTs in recent years and the increasing complexity and validity of tests, some of which directly competes with FDA approved diagnostic tests, brings about the question of why LDTs are not FDA regulated. The FDA has in fact recently released the LDT Regulatory Framework under review by congress calling for the regulation of moderate-risk (Cxbladder) and high-risk LDTs. Yes this has not yet been implemented, however, would that impede the uptake of Cxbladder in the US? Probably yes, reason why PE management are currently exploring the path to full FDA approval.

[Minerbarejet]

Current situation:
LDTs do not require FDA approval.
PEB operating within current LDT goalposts.
Advance notice given by FDA that rules will change once they get their FDA goalposts built and installed
PEB already taking steps to be ready when this change happens.

Future situation:
LDTs do require FDA approval.
PEB will move smoothly from LDT to FDA installed goalposts
PEB granted full FDA approval

:)

[skid]

Current situation:
LDTs do not require FDA approval.
PEB operating within current LDT goalposts.
Advance notice given by FDA that rules will change once they get their FDA goalposts built and installed
PEB already taking steps to be ready when this change happens.

Future situation:
LDTs do require FDA approval.
PEB will move smoothly from LDT to FDA installed goalposts
PEB granted full FDA approval

:)

IF ALL GOES TO PLAN--Meanwhile the bulls are carrying on as if the LDTs are just as good as FDA approval.(and that is just not a fact)
Future situation:
''PEB awaits confirmation from FDA to proceed with operations''--until FDA is on board this is not an impossibility

And how is a report that values PEB from $.42-$3.57 considered conservative??? Sounds to me like it is the full Monty from conservative to just plain Radical (@$3.57)

[steve06]

Just waiting on the half year report to see what study results are like, and their general progress to date.

[Minerbarejet]

Think you will find that operations such as PEB will be allowed to continue until the FDA have their rules and guidelines in place,
With this being some five years away LTDs will just have to do in the meantime.

Enough of this FDA, LTD, PEB. Im ready for an RTD.:)

[skid]

You got me on that one miner---RTD? (forgive me if im having a senior moment):)

[Minerbarejet]

Ready to drink, you know, lift your spirits. Nudge nudge

[Dentie]

Keep things in perspective. The FDA introducing regulation of LDT’s is a natural progression of a process that is now so complicated that the original intent is redundant.

FDA approval, is it achievable for CxBladder? Easy peasy, no drama, no sweat, it shouldn’t cause any undue stress to Pacific Edge shareholders.

I confirm this is the case...got directly from one of the horse's mouth about 3 months ago.

[pierre]

Enough of this FDA, LTD, PEB. Im ready for an RTD.:)

On Friday I'm hoping it will be time for a G'N T or, even better, an M O E T!

[Crystal Ball]

On Friday I'm hoping it will be time for a G'N T or, even better, an M O E T!
Hehe,
G' N T or even better an M O E T,
Heres hoping Fridays results earn us a tidy fee...
As they say "good things come to those that wait"
Glad I got my bundle o' peb shares cos after Fridays results, it might be too late!

[Minerbarejet]

If you could have a look in that crystal ball of yours and let us know what you see by Thursday, it would be really cool.

[Slam dunk]

Keep things in perspective. The FDA introducing regulation of LDT’s is a natural progression of a process that is now so complicated that the original intent is redundant.

Initially, LDTs were generally relatively simple, well-understood pathology tests that were intended to be used by physicians as part of patient care. But in recent years LDTs have become increasingly complex.

FDA approval, is it achievable for CxBladder? Easy peasy, no drama, no sweat, it shouldn’t cause any undue stress to Pacific Edge shareholders.

The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item’s planned use.

The FDA does not do its own testing of new drugs, medical devices, or other items. Instead, it reviews the results of clinical testing and studies performed by the item’s manufacturer.

The recent note from Forsyth Barr says they understand that the processes in the lab already comply with FDA regulations, in addition to the highest standards in the US so I don't think shareholders have much to worry about there.

[Crystal Ball]

If you could have a look in that crystal ball of yours and let us know what you see by Thursday, it would be really cool.

It's a wee bit hazy right now Minerbarejet however my intuition tells me that PEB is on track.....
I'm a patient long term holder like Mac n Hancocks so personally I am not watching the SP with bated breath like so many seem to be.....

[skid]

The recent note from Forsyth Barr says they understand that the processes in the lab already comply with FDA regulations, in addition to the highest standards in the US so I don't think shareholders have much to worry about there.

Im sure the product is capable of getting the approval--and they need to get it (IMO)if for no other reason than it is a ''good look''in terms of marketing the product.

[skid]

Hehe,
G' N T or even better an M O E T,
Heres hoping Fridays results earn us a tidy fee...
As they say "good things come to those that wait"
Glad I got my bundle o' peb shares cos after Fridays results, it might be too late!

That doesnt sound like a patient holder like Mac and Hancock who is not watching the SP with bated breath:):):)

[skid]

Hehe,
G' N T or even better an M O E T,
Heres hoping Fridays results earn us a tidy fee...
As they say "good things come to those that wait"
Glad I got my bundle o' peb shares cos after Fridays results, it might be too late!

Im a long term holder too-WHEN they show they are on track---Friday wont be too late--It just may cost more

a wise man once told me --Better to buy shares @$1.00 in an uptrend ,than at .80 on a downtrend

[klid]

Another patent granted for CxBladder, Europe.

[hilskin]

https://www.nzx.com/companies/PEB/announcements/258111

[MAC]

Yes, another very important string in the IP bow;

“The European Patent Office representing 38 countries in Europe has granted Pacific Edge patent protection for its Cxbladder technology that enables the accurate and non-invasive detection of urothelial carcinomas”

https://www.nzx.com/files/attachments/204465.pdf

[robbo24]

Another excellent announcement. However, I must be honest and admit that the timing worries me a bit. Hopefully this is not intended to mitigate the potential fall out from a poor results announcement at the end of the week (not that these results mean that much in the wider scheme of things)

PEB must have bribed the EU patent office to grant the patent just in time. Tinfoil hat plz :D:D:D:D:D:D:D:D:D:D:D:D:D

[robbo24]

The search for CxBladder in the European Patent Office doesn't seem to return anything yet, so I believe it has just been awarded and hence the announcement timing. Really good news for later down the track.

It's a material piece of information, if they didn't release it to the market then they would be in trouble.

I hear snapiti was banned, I might come back to the old PEB thread now.

[robbo24]

Trading halt...

:D

[hilskin]

Trading halt ???????

Please be gooooood news :-)

[Minerbarejet]

Another excellent announcement. However, I must be honest and admit that the timing worries me a bit. Hopefully this is not intended to mitigate the potential fall out from a poor results announcement at the end of the week (not that these results mean that much in the wider scheme of things) I hope not too. Out of left field again
Maybe have a think about what will happen if this combines with some good or reasonable HY results plus all the other positives we have had lately that have obviously been waiting for sales figures.


"Miner ducks for cover":):)

[robbo24]

PEB is going to announce its excitement at the banning of snapiti and the return to a normal rate-per-hour of postings to this thread and spelling-mistakes-per-post.

[klid]

Trading halt ???????

Please be gooooood news :-)

Ive missed out. GG

[winner69]

Trading halt ???????

Please be gooooood news :-)

Must be good news .....those in the know had a head start this morning

So what is the takeover / merger going to be for?

[psychic]

The search for CxBladder in the European Patent Office doesn't seem to return anything yet, so I believe it has just been awarded and hence the announcement timing. Really good news for later down the track.

https://register.epo.org/smartSearch?searchMode=smart&query=pacific+edge+biotechnology

Need to work through this

[QOH]

I hate trading halts, when one doesn't know if it's good or bad news. I have a horrible sense of Deja vu like just before last results.

[klid]

I hate trading halts, when one doesn't know if it's good or bad news. I have a horrible sense of Deja vu like just before last results.

I cant see how it could be bad... how???? Must be FANTASTIC And Im pissed. Lol

[klid]

Can you put orders on during the halt or nah?

[winner69]

I cant see how it could be bad... how???? Must be FANTASTIC And Im pissed. Lol

Be really pissed when $1.20 / $1.30 or maybe more tomorrow

[Baddarcy]

Can you put orders on during the halt or nah?

buy orders are still appearing, sell orders i can't see any movement.

[winner69]

They do anything to take the spotlight away from Orion first day of trading

[psychic]

Whoever it was that put the 250k lid in place at .85 to scare the herd on publishing of the draft must be dithering now..
Good job

[Minerbarejet]

Cant remember a trading halt before. Must be serious.

[psychic]

Perhaps Steve and Skid pointed out some problems?

[Minerbarejet]

Whoever it was that put the 250k lid in place at .85 to scare the herd on publishing of the draft must be dithering now..
Good jobAbsolutely right.

[twotic]

Perhaps Steve and Skid pointed out some problems?
Hah, maybe they actually did :)

Understand the TH is just to correct an error in the earlier announcement. Stand at ease...

[klid]

Be really pissed when $1.20 / $1.30 or maybe more tomorrow
Nah mate, I am getting on that bandwagon!


buy orders are still appearing, sell orders i can't see any movement.
Thanks.


Cant remember a trading halt before. Must be serious.
I am betting on CMS coverage.

[whatsup]

Understand the TH is just to correct an error in the earlier announcement. Stand at ease... and that would take 10 minutes not half an hour !

[winner69]

Maybe got told to quantify this statement ......Cxbladder technology that is already steadily gaining commercial traction in the USA as well as New Zealand and Australia.

Steadily gaining commercial traction = heaps of sales doesn't it

[pierre]

Understand the TH is just to correct an error in the earlier announcement. Stand at ease...

More likely a takeover offer I reckon. Who by and for how much? Start your guesses now!

[twotic]

Understand the TH is just to correct an error in the earlier announcement. Stand at ease...
Are you able to elaborate at all? Suspense is killing people. You hear that from a broker or the NZX or something?

[Harvey Specter]

Cant remember a trading halt before. Must be serious.Didn't tey do it when they signed the big deals?


Understand the TH is just to correct an error in the earlier announcement. Stand at ease...Damn. Must say it was weird to do two announcements so close together.

[whatsup]

More likely a takeover offer I reckon. Who by and for how much? Start your guesses now!

Rubbish, the management is there to "build " a company not sell it , and major overseas farma companies lets the "inventor " build it before they put their toe in the acquition water, that will happen on solid sales in 4-5 years time!

[slowbutsure]

Understand the TH is just to correct an error in the earlier announcement. Stand at ease...

That makes sense, this line:

Cxbladder Triage due to be released later this year.

is starting to sound pretty unlikely.

[couta1]

Where's Snapiti when you need him I see his name is not on the community list anymore either, most bans are temporal, the Snaps will be back.

[klid]

Rubbish, the management is there to "build " a company not sell it , and major overseas farma companies lets the "inventor " build it before they put their toe in the acquition water, that will happen on solid sales in 4-5 years time!

But that doesn't stop an offer from coming / being presented.

Suspense is killing me. If it's related to the initial one then I am pissed again :p