PEB - Pacific Edge Ltd

[calledone]

Looks like a pennant flag on the weekly. Hopefully March newsletter will have something good.

[Tsuba]

No it doesn't it looks like a Kandinsky.

[Greekwatchdog]

Info from NZ Herald. Paywall. Cancer diagnostic firm Pacific Edge and Skellerup Holdings will soon be added to the FTSE Global Small Cap Index. Skellerup surged 35c or 8.33 per cent to $4.55, and Pacific Edge climbed 7c or 6.93 per cent to $1.08.

https://www.nzherald.co.nz/business/market-close-strong-nz-dollar-and-mixed-results-weigh-down-sharemarket/6YB3WZHOGZVLBX35WFTW4Z4LQ4/

[thegreatestben]

Thanks for posting GWD, I did a little search and didn't come up with anything.

[Greekwatchdog]

No problems TGB, I only discovered it reading the column apart from that I was sort of scratching my head for todays increase.

[Maxtrade]

Info from NZ Herald. Paywall. Cancer diagnostic firm Pacific Edge and Skellerup Holdings will soon be added to the FTSE Global Small Cap Index. Skellerup surged 35c or 8.33 per cent to $4.55, and Pacific Edge climbed 7c or 6.93 per cent to $1.08.

https://www.nzherald.co.nz/business/market-close-strong-nz-dollar-and-mixed-results-weigh-down-sharemarket/6YB3WZHOGZVLBX35WFTW4Z4LQ4/

Hi 'Balance' and those in the know with PEB,

Any ideas why whenever there seems to be a little push up higher with the share price for PEB currently there seems to be a lot of resistance which then reverts the surge. Wouldn't those invested in PEB want to raise their sell orders at least into the 1.2-1.3 range to allow the share price to climb back up to where it was sitting for a while, and could comfortably retain at.

With continued growth and positive outlook for the company I don't see why some people seem to hinder the stock progressing moving forward. Or is it mainly just new retail traders just trying to make a bit of a quick buck, rather than looking at the bigger picture and letting the share price climb naturally higher. I don't see why there are so many sellers in the 1.1 range. If only they would just cancel there sell orders and allow the share price to push back up. Personally I feel these shares will soon be looked back on as a bargain at todays price.

Disclosure.
1- I am quite a large long term holder as I believe PEB are now on course to see some real growth with CX bladder, and believe it is a solid investment.
2- I am not soliciting a Reddit style push higher on the share price. I am just questioning why investors would be undercutting themselves for where the share price would otherwise be heading, if the ~850,000 sell orders for shares at 1.07 /1.1 were not sitting there restricting the market ever time it starts to push higher again. The chances that those sellers even read this is probably extremely unlikely anyway.

Thanks

[calledone]

Hi 'Balance' and those in the know with PEB,

Any ideas why whenever there seems to be a little push up higher with the share price for PEB currently there seems to be a lot of resistance which then reverts the surge. Wouldn't those invested in PEB want to raise their sell orders at least into the 1.2-1.3 range to allow the share price to climb back up to where it was sitting for a while, and could comfortably retain at.

With continued growth and positive outlook for the company I don't see why some people seem to hinder the stock progressing moving forward. Or is it mainly just new retail traders just trying to make a bit of a quick buck, rather than looking at the bigger picture and letting the share price climb naturally higher. I don't see why there are so many sellers in the 1.1 range. If only they would just cancel there sell orders and allow the share price to push back up. Personally I feel these shares will soon be looked back on as a bargain at todays price.

Disclosure.
1- I am quite a large long term holder as I believe PEB are now on course to see some real growth with CX bladder, and believe it is a solid investment.
2- I am not soliciting a Reddit style push higher on the share price. I am just questioning why investors would be undercutting themselves for where the share price would otherwise be heading, if the ~850,000 sell orders for shares at 1.07 /1.1 were not sitting there restricting the market ever time it starts to push higher again. The chances that those sellers even read this is probably extremely unlikely anyway.

Thanks

I don't think it's just investors or traders moving the price here(up or down). I think there is a lot of bot trading going on and who knows how these algorithms work(maybe someone more experienced here might be able to see this clearly). Recently on PEB I noticed the trade volume seems to increase after the southeast asians markets open around 2pm NZ time onwards. In saying that I doubt the share price will move up to previous highs until we see something good maybe in the upcoming newsletter.

[Minerbarejet]

[QUOTE=Maxtrade;874093]


"With continued growth and positive outlook for the company I don't see why some people seem to hinder the stock progressing moving forward".

You might ask the same question of the 100 buyers sitting within 4 cents not prepared to advance their bids and in doing so hindering the stock progress upwards.

You might also consider that they are in fact hindering any progress downwards which after a long and agonizing plunge to around 7 cents and back to 1.26 is encouraging.

[Balance]

Hi 'Balance' and those in the know with PEB,

Any ideas why whenever there seems to be a little push up higher with the share price for PEB currently there seems to be a lot of resistance which then reverts the surge. Wouldn't those invested in PEB want to raise their sell orders at least into the 1.2-1.3 range to allow the share price to climb back up to where it was sitting for a while, and could comfortably retain at.

With continued growth and positive outlook for the company I don't see why some people seem to hinder the stock progressing moving forward. Or is it mainly just new retail traders just trying to make a bit of a quick buck, rather than looking at the bigger picture and letting the share price climb naturally higher. I don't see why there are so many sellers in the 1.1 range. If only they would just cancel there sell orders and allow the share price to push back up. Personally I feel these shares will soon be looked back on as a bargain at todays price.

Disclosure.
1- I am quite a large long term holder as I believe PEB are now on course to see some real growth with CX bladder, and believe it is a solid investment.
2- I am not soliciting a Reddit style push higher on the share price. I am just questioning why investors would be undercutting themselves for where the share price would otherwise be heading, if the ~850,000 sell orders for shares at 1.07 /1.1 were not sitting there restricting the market ever time it starts to push higher again. The chances that those sellers even read this is probably extremely unlikely anyway.

Thanks

Two points to note :

1. PEB has been and is still an excellent trading stock for some of the players out there - so we will continue to see traders play with the stock for the 5% to 10% they can make. If they buy at $1.00, out they go at $1.05 to $1.10 - theirs is not a long term game and they also have to watch out for one another to see who gets in and out faster than the other!

The traders who missed out on the index-induced announcement surge on 22 Feb to $1.08 are lining up presumably today to get taken out.

Recall the NZX50 inclusion in October 2020 which saw the stock surged from 65c to 78c, then retracing down !0% back to 69c post index inclusion?

2. PEB is still very much an event driven stock - until such time as the cash starts pouring in from sales, this will continue to be the case.

[t.rexjr]

Hi 'Balance' and those in the know with PEB,

Any ideas why whenever there seems to be a little push up higher with the share price for PEB currently there seems to be a lot of resistance which then reverts the surge. Wouldn't those invested in PEB want to raise their sell orders at least into the 1.2-1.3 range to allow the share price to climb back up to where it was sitting for a while, and could comfortably retain at.

With continued growth and positive outlook for the company I don't see why some people seem to hinder the stock progressing moving forward. Or is it mainly just new retail traders just trying to make a bit of a quick buck, rather than looking at the bigger picture and letting the share price climb naturally higher. I don't see why there are so many sellers in the 1.1 range. If only they would just cancel there sell orders and allow the share price to push back up. Personally I feel these shares will soon be looked back on as a bargain at todays price.

Disclosure.
1- I am quite a large long term holder as I believe PEB are now on course to see some real growth with CX bladder, and believe it is a solid investment.
2- I am not soliciting a Reddit style push higher on the share price. I am just questioning why investors would be undercutting themselves for where the share price would otherwise be heading, if the ~850,000 sell orders for shares at 1.07 /1.1 were not sitting there restricting the market ever time it starts to push higher again. The chances that those sellers even read this is probably extremely unlikely anyway.

Thanks

No one needs to buy, but there are always those that need to sell...

[Balance]

No one needs to buy, but there are always those that need to sell...

As has been said, there’s really only one reason why people buy a stock but many many reasons why people sell.

[ecuttel]

https://www.odt.co.nz/business/global-domination-dunedin

"For us going forward, we have to get some serious capital and start doing more of what we’ve done."

[baaantom]

The business update newsletter due out in the next few weeks (as confirmed with investor relations) should be telling.

Wouldn't be surprised if there was a capital raise this year, assuming CMS doesn't reimburse for past tests. However it shouldn't be all that dilutive given the current share price.

[850man]

The business update newsletter due out in the next few weeks (as confirmed with investor relations) should be telling.

Wouldn't be surprised if there was a capital raise this year, assuming CMS doesn't reimburse for past tests. However it shouldn't be all that dilutive given the current share price.

Hoping the good news continues with reimbursements from CMS - time will tell

[Balance]

Hoping the good news continues with reimbursements from CMS - time will tell

If CMS comes through, there should be no need for capital raising - US$40m (NBR source) waiting to be collected.

[calledone]

“ In the future, it was likely another hub lab would be set up in Singapore for logistical reasons.”.

Was that an analysis from the reporter or DD’s confidence from increasing uptake in that region? I don’t remember this mentioned in previous meetings or it’s just inevitable if numbers are increasing.

[Greekwatchdog]

Singapore is another area they have been working on. Natural to have this as a hub as not far from next large market China.

[barney]

When David Darling is talking about " serious capital " I doubt he's referring to going back to existing shareholders via the NZX to raise funds. I think " serious capital " would more likely be a listing on an offshore exchange or partnering up with a larger existing market player. I think the days of raising 30 or 40 million locally are probably over.

[calledone]

Sounds about right since he is talking about global domination 😂 - “ We have global domination from Dunedin, that’s our plan and we love being here.”

[Sideshow Bob]

342036.pdf (nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com) (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/368846/342036.pdf)

Salt taking some profits off the table.

[LEMON]

...... Mistake

[LEMON]

https://www.nzx.com/announcements/368849

[LEMON]

https://www.nzx.com/announcements/368849

Like what she has to say in regards to positive outlook on future growths

[BigBob]

342036.pdf (nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com) (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/368846/342036.pdf)

Salt taking some profits off the table.

Errr... No... They have just over 22 mill more than at last disclosure (although percentage is lower)....

[iamaskier]

Errr... No... They have just over 22 mill more than at last disclosure (although percentage is lower)....

True but the date of the relevant event and the table at the top of page 2 makes it look like it was a recent sell that triggered the disclosure? Whole notice kinda confusing tbf...

[BigBob]

True but the date of the relevant event and the table at the top of page 2 makes it look like it was a recent sell that triggered the disclosure? Whole notice kinda confusing tbf...

Those SSH noticed are often totally confusing... You'd think someone could come up with a simple, standardised way of reporting movements...

[Greekwatchdog]

This part also appeals "Glaxo Smith Kline". Nice timing by the company being International Woman Week. Good PR

[LEMON]

My thoughts also, has that sentiment of women leading.
Sounds like she knows what's she doing anyway and has the experience and contacts to help pacific edge move further in the growth stages.
All the best to her.

[BigBob]

Those SSH noticed are often totally confusing... You'd think someone could come up with a simple, standardised way of reporting movements...

And according to the amendment (http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/368850/342040.pdf) they have actually reduced their holdings recently... I think....

As you were everyone...

[LEMON]

Morning all.
Rookie question, is it common for independent directors to buy shares in a company?
If our new independent director buys shares in PEB would that be perceived as a great outlook for the future or is it normal behaviour, similar to the boards buying behaviour?
Thanks

[Balance]

Morning all.
Rookie question, is it common for independent directors to buy shares in a company?
If our new independent director buys shares in PEB would that be perceived as a great outlook for the future or is it normal behaviour, similar to the boards buying behaviour?
Thanks

Depends on how many they buy and at what prices.

There is tokenism and there is real commitment.

I must admit this is one I missed :

https://simplywall.st/stocks/nz/pharmaceuticals-biotech/nzx-peb/pacific-edge-shares/news/read-this-before-selling-pacific-edge-limited-nzsepeb-shares

[LEMON]

https://www.nzx.com/announcements/369177

[calledone]

https://www.nzx.com/announcements/369177

Looks like a welcome token for her. Must be FOC?

[LEMON]

https://www.nzx.com/announcements/369435

[trader_jackson]

is David building another deck?

[calledone]

Maybe his kid going to university overseas. Looks like the sell lot was under one of his family members name.

[850man]

is David building another deck?
Last time David pulled this stunt to "build a deck" the SP dropped 20%

[hei]

Could this have anything to do with the March newsletter and its potential positive or negative effects on the SP??

[Minerbarejet]

Last time David pulled this stunt to "build a deck" the SP dropped 20%The last time DD "pulled this stunt" if I recall the SP was up in the 120 range and there was a rights issue going on at 40c.
Pretty obvious that DD hadnt expected the market reaction of taking off like a rocket after announcing a few providers signing up , all ably assisted by Balance giving 5.00 as a possible SP and something to look forward to.

I kid you not.

[Balance]

The last time DD "pulled this stunt" if I recall the SP was up in the 120 range and there was a rights issue going on at 40c.
Pretty obvious that DD hadnt expected the market reaction of taking off like a rocket after announcing a few providers signing up , all ably assisted by Balance giving 5.00 as a possible SP and something to look forward to.

I kid you not.

You are wrong of course.

$5.00? That was only the first stop towards $10.00 at least imo at that time.

That is until the failure to clarify & substantiate the 'several tens of thousands of tests' comment by the then Chairman Swann & the selling of shares by DD (twice) & the chairman after the very bullish comments, remember?

And the Huljichs & Masfens took the same opportunity to sell heaps of their shares as well on the back of the spike in the sp following the Chairman's extremely bullish comments?

One of the most disgraceful episodes in NZ's corporate history imo.

[calledone]

You are wrong of course.

$5.00? That was only the first stop towards $10.00 at least imo at that time.

That is until the failure to clarify & substantiate the 'several tens of thousands of tests' comment by the then Chairman Swann & the selling of shares by DD (twice) & the chairman after the very bullish comments, remember?

And the Huljichs & Masfens took the same opportunity to sell heaps of their shares as well on the back of the spike in the sp following the Chairman's extremely bullish comments?

One of the most disgraceful episodes in NZ's corporate history imo.

Is this something that happened in 2015?

[Balance]

Is this something that happened in 2015?

Dec 2013 when Swann made the comments & share sales by insiders took place in early 2014.

https://www.odt.co.nz/business/pacific-edge-business

“ ..... several tens of thousands of tests” in 2014 & US$100m revenues in 5 years.

Fast forward to 2020:

16,861 tests done in FY2020

Revenues NZ$4.4m

[calledone]

Dec 2013 when Swann made the comments & share sales by insiders took place in early 2014.

https://www.odt.co.nz/business/pacific-edge-business

“ ..... several tens of thousands of tests” in 2014 & US$100m revenues in 5 years.

Fast forward to 2020:

16,861 tests done in FY2020

Revenues NZ$4.4m

Looks like they were off by about 10 years haha! 100m might be possible by 2025 if new markets open up and US market is tracking according to plan without any major headwinds.

I noticed their cxbladder tests can now be bought online by anyone locally. Thought that was an interesting development. https://order.cxbladder.com/index.php?route=product/product&product_id=50

[Balance]

Looks like they were off by about 10 years haha! 100m might be possible by 2025 if new markets open up and US market is tracking according to plan without any major headwinds.

I noticed their cxbladder tests can now be bought online by anyone locally. Thought that was an interesting development. https://order.cxbladder.com/index.php?route=product/product&product_id=50

That's all in the past of course - what's important is how PEB is going to fare going forward with 2020 being the year of the reset imo.

2 things which will drive the sp in the next results = reimbursement of the US$40m tests done but not paid & how many tests done since the LCD was obtained.

Comfortable to hold until then.

[shwatch]

PEB NZX Spotlight video this month
https://www.youtube.com/watch?v=NEwC4n8CWWc

[jridler]

That's all in the past of course - what's important is how PEB is going to fare going forward with 2020 being the year of the reset imo.

2 things which will drive the sp in the next results = reimbursement of the US$40m tests done but not paid & how many tests done since the LCD was obtained.

Comfortable to hold until then.

Sorry Balance, could you remind me where this $40m figure is coming from for the potential CMS reimbursement? There are 22,000+ tests which they are negotiating reimbursement for, and the agreed price per test from 1 July 2020 is US$760 per test. I can't quite tie up the $40m figure that seems to be bouncing around.

[Balance]

Sorry Balance, could you remind me where this $40m figure is coming from for the potential CMS reimbursement? There are 22,000+ tests which they are negotiating reimbursement for, and the agreed price per test from 1 July 2020 is US$760 per test. I can't quite tie up the $40m figure that seems to be bouncing around.

https://businessdesk.co.nz/article/coronavirus/pacific-edge-seeks-us40m-backpay-from-us-administrator

Pacific Edge is chasing 22,000 outstanding invoices dating back to 2015 as it seeks up to US$40 million in backpay from US medical aid administrator Novitas.

[Balance]

Sorry Balance, could you remind me where this $40m figure is coming from for the potential CMS reimbursement? There are 22,000+ tests which they are negotiating reimbursement for, and the agreed price per test from 1 July 2020 is US$760 per test. I can't quite tie up the $40m figure that seems to be bouncing around.

https://businessdesk.co.nz/article/coronavirus/pacific-edge-seeks-us40m-backpay-from-us-administrator

Pacific Edge is chasing 22,000 outstanding invoices dating back to 2015 as it seeks up to US$40 million in backpay from US medical aid administrator Novitas.

[Sgt Pepper]

"Hello is that Novias? its PEB here could you pay us $40miilion?
Novitas: "do we have to?"
PEB: "no"
Novitas: "Goodbye"

[Minerbarejet]

So the conclusion we can come to with all that is that any competitor looking to enter the field would be obliged to stump up some 20,000 odd tests free of charge to get recognised.Would be a big ask, that one.Might look at the NZ US exchange rate as an indicator as to the amounts but it does seem that 40mill is a bit high.

[850man]

https://businessdesk.co.nz/article/coronavirus/pacific-edge-seeks-us40m-backpay-from-us-administrator

Pacific Edge is chasing 22,000 outstanding invoices dating back to 2015 as it seeks up to US$40 million in backpay from US medical aid administrator Novitas.

Isn't that article from back in August 2020? About time they reported on how that's going.

A more recent article here https://businessdesk.co.nz/index.php/article/listed-companies/pacific-edge-poised-for-us12-billion-opportunity?bibblio=true with a more positive note.

Interesting - massive volume traded on Friday, 12 million shares, almost all at 5:00pm close

[Balance]

Isn't that article from back in August 2020? About time they reported on how that's going.

A more recent article here https://businessdesk.co.nz/index.php/article/listed-companies/pacific-edge-poised-for-us12-billion-opportunity?bibblio=true with a more positive note.

Interesting - massive volume traded on Friday, 12 million shares, almost all at 5:00pm close

Indexing

https://www.nzx.com/announcements/369387

[kiwidollabill]

FYI still trying to find a COO

[calledone]

FYI still trying to find a COO

Hope there will be a bit more than that in the newsletter haha!

[850man]

Hope there will be a bit more than that in the newsletter haha!

Anyone know when we can expect the next meaningful update from PEB?

[calledone]

Anyone know when we can expect the next meaningful update from PEB?

The newsletter should be the next update supposed to be in March but they are usually late going by the last two newsletter cycles. So maybe 1st or 2nd week of April.
https://www.pacificedgedx.com/investors/key-dates/

[LEMON]

It's say tomorrow on the Reap site.

[calledone]

It's say tomorrow on the Reap site.

Can you post the link please.

[LEMON]

Not sure how to share screenshots.
If you download the app REAP.
It's got all the NZ companies and the latest information.
A nice cleaner version of the NZX announcement board, you can find it there.

[Baa_Baa]

Can you post the link please.

Reap is an App for your phone.

[LEMON]

You can also include only your companies of who you are concerned. So cut out the noise.
Gets reliable fast notifications of announcements without checking the NZX board.

[850man]

Reap is an App for your phone.
Thanks Baa Baa

[calledone]

Reap is an App for your phone.

Oh yes, thanks but couldn't find anything other than financial year end date which is tomorrow (Didn't think there will any announcement on that till May.)

[LEMON]

Add the company and check events section

[LEMON]

Sorry guys, not sure its an announcement maybe only notice of half year end.
Still a good app

[Rawz]

Yes- Reap app is great. And free!

[Greekwatchdog]

New Agreement https://www.nzx.com/announcements/370004

[Habits]

New Agreement https://www.nzx.com/announcements/370004

What are the likely sales and margins ... 170k patients

[Alpha]

How is this not price sensitive?

[artemis]

What are the likely sales and margins ... 170k patients

The company says not huge, but more important is that it was the urologists that asked for it. And that others in the group will now be more likely to join up as well. Potential snowball effect.

[calledone]

The company says not huge, but more important is that it was the urologists that asked for it. And that others in the group will now be more likely to join up as well. Potential snowball effect.

Yeah very good indication they are gaining good traction in the US. Very good news IMHO.

[Getty]

Announcement made just in time to stop the SP dropping below the 100 day MA

[Watchful]

Facey website lists 4 urologists on staff.
If we make a few assumptions, we can get an extremely rough ballpark figure.

1) Assume all four include cxbladder in their processes.
2) Assume each urologist refers a single patient for one of the cxbladder tests once per day. (Biggest assumption, I have no basis for this one, someone with knowledge please chip in..)
3) Assume Facey are paying the same CMS-agreed rate of US$760 per test.
4) Assume 48 clinic weeks a year, gotta let them rest sometime.

4 Urologists x 5 tests a week x 48 weeks x $760 = $729,600 USD potential contribution to revenue.

As above.. all assumptions. Final figure could be a 10% of this number, could be double, or something else entirely. Would dearly love to hear from someone experienced who could zero in on how many patients a Urologist may have cause to refer for testing in any given week.

Overall, I feel this is more a potential foot in the door to another large payer, and consider it an extremely good sign that they sought out PEB themselves after using the tests and finding them beneficial.

[Rawz]

The company says not huge, but more important is that it was the urologists that asked for it. And that others in the group will now be more likely to join up as well. Potential snowball effect.

You hit the nail on the head!

[Minerbarejet]

This is important but seems to be missed:

Facey Medical Group is a multi-specialty medical group with over 180 physicians providing care to more than 170,000 patients in the North & East regions of Los Angeles & Ventura Counties in California. This makes it similar in size to the Mid-Central District Health Board in New Zealand. Facey Medical Group is also one of six California physician groups affiliated with, or owned by Providence Health & Services, one of the largest health systems in the Western United States.

Also it is not just about urologists as some physicians will be involved as well. So a bit hard to put any kind of figure on it.

[Leftfield]

I’m heavily invested in both PEB and IKE and great to see them both making steady progress in USA. Both featuring on the leaderboard today. Onwards and upwards.

[Maxtrade]

I’m heavily invested in both PEB and IKE and great to see them both making steady progress in USA. Both featuring on the leaderboard today. Onwards and upwards.

Very positive news. We have family members who are doctors/ urologists US based and apparently CX is starting to be heard of and abuzz. Integration is likely to follow more mainstream public health sectors as positive reviews flow. This is a good stepping stone, and the recognition here is wonderful for PEB. Great news. We will secure some more shares while the SP is still low at 1.02. This will seem like a bargain price within a short period of time. Looks like the analysts targets of 1.4 within the year is well on the cards :)

[850man]

probably seen this before as it's from early Feb https://www.urologytimes.com/view/bladder-cancer-biomarker-test-accurately-adjudicates-atypical-cytology (https://www.urologytimes.com/view/bladder-cancer-biomarker-test-accurately-adjudicates-atypical-cytology)
Some good, positive publicity for CXBladder's effectiveness.

[Retired Doc]

Very positive news. We have family members who are doctors/ urologists US based and apparently CX is starting to be heard of and abuzz. Integration is likely to follow more mainstream public health sectors as positive reviews flow. This is a good stepping stone, and the recognition here is wonderful for PEB. Great news. We will secure some more shares while the SP is still low at 1.02. This will seem like a bargain price within a short period of time. Looks like the analysts targets of 1.4 within the year is well on the cards :)

I recently spoke with a young NZ Urologist who’s opinion was that PEB was a definite “hold”. I was prompted to make another modest accumulation. When do we expect the March announcement? ��

[Greekwatchdog]

Full Year result 28th May. As for Investor Update - any day..

[Sideshow Bob]

Trading halt....

Pacific Edge Limited (“PEB”) - Trading Halt of Securities - NZX, New Zealand’s Exchange (https://www.nzx.com/announcements/370431)

[BigBob]

Trading halt....

Pacific Edge Limited (“PEB”) - Trading Halt of Securities - NZX, New Zealand’s Exchange (https://www.nzx.com/announcements/370431)

The halt has been put in place while PEB drafts a response to information in public domain.

Any ideas...?

[McPussPuss]

Any idea what "information" is "in public domain."?

[stoploss]

Any idea what "information" is "in public domain."?
https://www.odt.co.nz/business/pacific-edge-praised

Did they announce anything to the NZX yesterday ????

[jonu]

https://www.odt.co.nz/business/pacific-edge-praised

Did they announce anything to the NZX yesterday ????

Check the date stoploss

[BigBob]

https://www.odt.co.nz/business/pacific-edge-praised

Did they announce anything to the NZX yesterday ????

That's from 2014...


Any idea what "information" is "in public domain."?

It sure isn't their Newsletter....! Why state that you will release a newsletter in March and then not do it...?

[stoploss]

Check the date stoploss
Sorry thats an Epic fail, mmmm saw the 9 April at the top of the page .......

[Watchful]

That article is dated 2014, so don’t think it’s that.

[McPussPuss]

My guess is something was published in the states to their surprise that is material and they need to halt trading to catch up and comply.

[LEMON]

I think it's good news. With new acting directors and facey medical now on board. A new team for growth its got to be something big, maybe another country or another organisation using Cx Bladder?
Pure speculation but I would rather remain positive

[trader_jackson]

Usually when a company needs to halt trading in their shares due to something in the public domain (what ever that is) it isn't good news...

[LEMON]

Yes but not always. Is there a correction possibly? Been no recent announcement apart from Facey medical

[Minerbarejet]

Perhaps the long awaited payout from CMS for services rendered or conversely confirmation its not coming.
Hope its the former.

[Balance]

The halt has been put in place while PEB drafts a response to information in public domain.

Any ideas...?

Direction of sp in last few days can provide a clue but in this case, nothing conclusive - sp directionless on light volumes since indexing pushed sp up to $1.04 on 19 March.

Sounds to me like there's information being shared in the market which has been brought to PEB's attention for comment and it's material & significant enough to warrant a trading halt.

Could be very positive or very negative - not in-between, I would say! :scared:

[trader_jackson]

Usually when a company needs to halt trading in their shares due to something in the public domain (what ever that is) it isn't good news...

https://www.nzx.com/announcements/370436
Sounds like very good news!

[LEMON]

It's very good news.
This will make CX bladder more accessible and allow for more room to move through the medical world I would hope.

[stoploss]

Bit of a worry they took a week to release the announcement .......

[pierre]

Fantastic news for PEB - onwards and upwards from here.

I was a bit worried the Trading Halt might have signified a T/O bid - until I read it. Much too soon for one of those for current shareholders but I wouldn't mind betting there will be a number of US companies with eyes on PEB over the next year or so.

[Leftfield]

https://www.nzx.com/announcements/370436
Sounds like very good news!

Great news!

"Effective from 1 April 2021, Cxbladder is now being covered as a ‘medically necessary bladder tumor marker test’, under United Healthcare’s Molecular Pathology/Molecular Diagnostics/Genetic Testing (Medicare Advantage) - Medical Policy.

United Healthcare has over 50 million members with more than 5.7 million Medicare Advantage members. In 2019, UnitedHealth Group had a 14.1 percent share of the U.S. health insurance market, with direct premiums written amounting to approximately US$107 billion . The organisation partners with 6,500 hospitals and care facilities nationwide, and more than 1.3 million physicians and other providers."

[kerryo]

Sharemarket likes it.

[LEMON]

Agree, it seemed to early for a T/O.
With all the new board members and latest new of facey, it signed to me that the company is now aggressively pushing in the US for growth. Just seemed right to be good news.

[Snow Leopard]

It appears that UHC added it to their policy on 10th March: [ link (https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/m/molecular-pathology-diagnostics-genetic-testing.pdf&ved=2ahUKEwiZkPvF4O_vAhVlyzgGHXZoAuMQFjAAegQIBhAC&usg=AOvVaw0jXj8lLzlmgrAVEcIEmHxX) ]

Just need the approval to turn into usage.

[Cyclical]

Sold mine a month ago of course. Oh well, back in again ;-)

[Minerbarejet]

"Medically necessary" might make the AUA sit up and take notice.

[Balance]

Bit of a worry they took a week to release the announcement .......

In violation of their Continuous Disclosure obligation (again)?

[Watchful]

Reading closely, they may not have been aware! Nothing mentioned about an agreement or similar, simply noting that UHC has updated their policy coverage to support it, probably under the CMS framework.

[thegreatestben]

Yowzer what a great start to Friday.

[calledone]

Wow! Just came back to see this news. Well done to all those patient holders. I think analysts might increase their target soon too. Like I said earlier, hope there won’t be a takeover too soon. I really hope PEB will be the 2nd or 3rd NZ entity to list in the US market. Still hoping to hear a positive news on this side of the world (Singapore) which will be a door wide open to China. Cheers to all holders!

[Minerbarejet]

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=58529&ver=3&lcdid=35396&keyword=Cxbladder&keywordType=sta

Look to the comments section for additional insight.

[Bjauck]

"Medically necessary" might make the AUA sit up and take notice. It may be on the radar of American Investors now. At least the SP is now higher than I paid in 2014!

[pierre]

The initial euphoria has subsided - as it inevitably does.

Never mind - still plenty more good news to come from PEB over the next few years. I'm still expecting the SP to reach $5.00 ...one day.:)

Bonne chance to holders.

[Minerbarejet]

The initial euphoria has subsided - as it inevitably does.

Never mind - still plenty more good news to come from PEB over the next few years. I'm still expecting the SP to reach $5.00 ...one day.:)

Bonne chance to holders.
Thought they were going to bring out the traffic cones and Hi viz gear there for a while this morning
Only 3.75 to go Pierre.
Piece of cake

[Maxtrade]

It may be on the radar of American Investors now. At least the SP is now higher than I paid in 2014!

Have heard through associates in the medical field in Singapore that the viability and introduction of CX is definitely abuzz topic of conversation. Lets hope it all comes together for PEB and they are able to crack the Asian market too. Then the $5/share price might go much higher. Great returns for long term holders. But most importantly great news for the potential of another internationally recognised New Zealand company to climb up the stock market and finally get the rewards they deserve.

[850man]

"Medically necessary" might make the AUA sit up and take notice.

Not just the AUA but also other medical insurers in the USA might find themselves under pressure to adopt CXbladder in the same way as United Healthcare. Keep up the good work PEB!

[Minerbarejet]

As this has come out of left field so to speak this might be an opportune time to refresh a few memories on some expected events in the near future.

This may only be a partial list.

An expected payment of CMS tests completed prior to inclusion by CMS, or part thereof.

Confirmation of the Johns Hopkins Commercial assessment and what their findings are.

A Clinical study from Kaiser published.

A Clinical study from Singapore published.

A Definitive end of year result published in May that will show the rate of acceptance and payment across the board for the last 6 months.

[peetter]

I guess sometimes taking financial advice from internet forums pays off, just bought some on Tuesday because I liked what you guys are saying and see the potential of the product. Thanks ;)

[Maxtrade]

I guess sometimes taking financial advice from internet forums pays off, just bought some on Tuesday because I liked what you guys are saying and see the potential of the product. Thanks ;)

Beats me why on earth the SP hasn't held at 1.3 today and has subsequently dropped back down to 1.2 now. I think there are some PEB traders that don't quite understand (or care less) that the growth potential for PEB as it stands at 1.20 is still at least 15-20% less than what analysts feel the share price should be sitting at. Now with todays news and more good news on the horizon, it is very likely in the coming days there will be analysts increasing their indicative targets.

Those that have been selling down today from 1.3 to 1.2 should probably consider buying back in again now before this happens and we see the second spike up which will surpass todays high. Previous Analysts SP 1.4-1.5 realistically will be hit shortly (once these profit takers get out the way selling down from todays high). Shareholders who see the fundamental value will likely take the opportunity to secure more shares at todays low SP of 1.20, knowing the direction the company is heading forward now.

[Minerbarejet]

Beats me why on earth the SP hasn't held at 1.3 today and has subsequently dropped back down to 1.2 now. I think there are some PEB traders that don't quite understand (or care less) that the growth potential for PEB as it stands at 1.20 is still at least 15-20% less than what analysts feel the share price should be sitting at. Now with todays news and more good news on the horizon, it is very likely in the coming days there will be analysts increasing their indicative targets.

Those that have been selling down today from 1.3 to 1.2 should probably consider buying back in again now before this happens and we see the second spike up which will surpass todays high. Previous Analysts SP 1.4-1.5 realistically will be hit shortly (once these profit takers get out the way selling down from todays high). Shareholders who see the fundamental value will likely take the opportunity to secure more shares at todays low SP of 1.20, knowing the direction the company is heading forward now.
Given the numbers of sellers and the amounts involved I would suggest a fair few Sharesies at work.

[Leftfield]

Beats me why on earth the SP hasn't held at 1.3 today and has subsequently dropped back down to 1.2 now. I think there are some PEB traders that don't quite understand (or care less) that the growth potential for PEB as it stands at 1.20 is still at least 15-20% less than what analysts feel the share price should be sitting at. Now with todays news and more good news on the horizon, it is very likely in the coming days there will be analysts increasing their indicative targets.

Those that have been selling down today from 1.3 to 1.2 should probably consider buying back in again now before this happens and we see the second spike up which will surpass todays high. Previous Analysts SP 1.4-1.5 realistically will be hit shortly (once these profit takers get out the way selling down from todays high). Shareholders who see the fundamental value will likely take the opportunity to secure more shares at todays low SP of 1.20, knowing the direction the company is heading forward now.

I agree..... and couldn't resist buying more today. My DCA still a paltry 61c so a nice safety margin and PEB now 27% of my portfolio. Feeling 'well positioned'. Onwards and upwards.

GLH.

[Zeitgeist]

Have heard through associates in the medical field in Singapore that the viability and introduction of CX is definitely abuzz topic of conversation. Lets hope it all comes together for PEB and they are able to crack the Asian market too. Then the $5/share price might go much higher. Great returns for long term holders. But most importantly great news for the potential of another internationally recognised New Zealand company to climb up the stock market and finally get the rewards they deserve.

I'm inclined to agree with your comment and a lot of hard work has gone into getting PEB to where it is today. This has gone sideways since I first purchased nearly 10 years ago. Just wanted to query 2 things:

1. $5/share is based on what exactly?
2. "The rewards they deserve" - the company is currently priced well above what its actual financial results suggest is reasonable. The valuation gap is based on hot air, yes there are very positive signs in that hot air, but delivery on targets and results is what will see PEB's share price climb. Until delivery happens, PEB deserves to be priced based on their past which is underdelivering on overly ambitious targets.

[whatsup]

One would have to say that PEB's dark and scarry days are behind it, there should be many more of announcements such as were released today coming in the future months and years.

[pierre]

I'm inclined to agree with your comment and a lot of hard work has gone into getting PEB to where it is today. This has gone sideways since I first purchased nearly 10 years ago. Just wanted to query 2 things:

1. $5/share is based on what exactly?
2. "The rewards they deserve" - the company is currently priced well above what its actual financial results suggest is reasonable. The valuation gap is based on hot air, yes there are very positive signs in that hot air, but delivery on targets and results is what will see PEB's share price climb. Until delivery happens, PEB deserves to be priced based on their past which is underdelivering on overly ambitious targets.

Haha. Your question #1 is very wise and proves that nobody should necessarily believe everything they read on ST.

A $5.00 SP is my just reward for backing the company through thick and thin for the past nine years, including supporting numerous cash raises and coping with all the angst and BS on this site! There's no science at all attached to the number - it's simply plucked out of the air and I have no idea at all if or when it might be achieved - but we are all allowed to dream. :D

As for Q2 - it's all about the potential and everyone will have their own view on where this company is headed. I don't know where the SP will land - but I'm certain the overall trajectory is "up". However, I'm equally sure that the roller coaster experience will occur every time there's a good (or bad) news announcement. I'm simply staying buckled in for the ride.

[Mel]

As this has come out of left field so to speak this might be an opportune time to refresh a few memories on some expected events in the near future.

This may only be a partial list.

An expected payment of CMS tests completed prior to inclusion by CMS, or part thereof.

Confirmation of the Johns Hopkins Commercial assessment and what their findings are.

A Clinical study from Kaiser published.

A Clinical study from Singapore published.

A Definitive end of year result published in May that will show the rate of acceptance and payment across the board for the last 6 months.

This should create some additional momentum, I've held on for many years and starting to see some great returns now - my only regret is that I sold a small parcel of shares for a very small profit a couple of years ago. The succession of good news bodes well in the event of an eventual takeover.

[Minerbarejet]

This should create some additional momentum, I've held on for many years and starting to see some great returns now - my only regret is that I sold a small parcel of shares for a very small profit a couple of years ago. The succession of good news bodes well in the event of an eventual takeover.
There is also a medium to long term list some of which hinges on the success of cxBladder.

I feel that a certain amount of some of the following is already accounted for in the SP as it appears to be out of whack with results

An announcement regarding the 4th Resolve test launching in the USA

Achieving a continuous profit.

Accumulating sufficient profits in order to speed up the advance of the substantial pipeline of other tests under development.

Payment of a dividend.

Building of further laboratories.

Any takeover may require divestment of the cxbladder division alone as a separate entity leaving the pipeline in Pacific Edge's hands.


More to this than immediately meets the eye.

Opinion only and not financial advice.

[calledone]

After digesting the significance of this announcement I feel this is much bigger than I initially thought. Someone please correct me if I’m wrong.

United healthcare is 4+ times larger than kaiser permanente with 5.7million medicare advantage patients. So if we say they take the cxBladder test once a year(since its “medically necessary”) thats around nz$6 Billion in revenue(taking US$760 per test).

United healthcare has partnership with 1.3 million physicians whereas KP only had 23k so even if not all 5.7million patients take the test, the chance of utilising this test is significantly greater. Even if only a 3rd took the test that would be nz$2 Billion in revenue.

Is this a reasonable assumption?

Success breeds more success and I think David Darling’s aspirations of global domination might have has taken a giant leap forward! now that more insurers and physicians around the world are going to take notice.

[Mel]

After digesting the significance of this announcement I feel this is much bigger than I initially thought. Someone please correct me if I’m wrong.

United healthcare is 4+ times larger than kaiser permanente with 5.7million medicare advantage patients. So if we say they take the cxBladder test once a year(since its “medically necessary”) thats around nz$6 Billion in revenue(taking US$760 per test).

United healthcare has partnership with 1.3 million physicians whereas KP only had 23k so even if not all 5.7million patients take the test, the chance of utilising this test is significantly greater. Even if only a 3rd took the test that would be nz$2 Billion in revenue.

Is this a reasonable assumption?
Success breeds more success and I think David Darling’s aspirations of global domination might have has taken a giant leap forward! now that more insurers and physicians around the world are going to take notice.

I expect that 'medically necessary' is in context of those at risk or those who are currently symptomatic, so your revenue forecasts are rather optimistic - your relative assessment of Kaiser vs United patients is valid. Ultimately, we are looking for the revenue that we should be seeing from the reimbursements, so that needs to be the next material update IMHO - I've been waiting for this for a while!

[Minerbarejet]

After digesting the significance of this announcement I feel this is much bigger than I initially thought. Someone please correct me if I’m wrong.

United healthcare is 4+ times larger than kaiser permanente with 5.7million medicare advantage patients. So if we say they take the cxBladder test once a year(since its “medically necessary”) thats around nz$6 Billion in revenue(taking US$760 per test).

United healthcare has partnership with 1.3 million physicians whereas KP only had 23k so even if not all 5.7million patients take the test, the chance of utilising this test is significantly greater. Even if only a 3rd took the test that would be nz$2 Billion in revenue.

Is this a reasonable assumption?

Success breeds more success and I think David Darling’s aspirations of global domination might have has taken a giant leap forward! now that more insurers and physicians around the world are going to take notice.
Whew! Some parts are right, mate.
You are about right with the total that United is 4 times bigger than Kaiser (and thus nearly equivalent to CMS)

Doubtful there is any intention to test patients for bladder cancer as a screening process generally overall.
cxBladder Triage will be useful for persons presenting with haematuria to rule out bladder cancer.
So therefore there would have to be some possible symptoms appearing first.
Apparently there are some 2,000,000 presentations for that in the entire US medical scene annually.
There are also some 800,000 patients requiring ongoing monitoring for recurrence following a bladder cancer operation.
These are in some cases carried out 2 or 3 times a year over 5 years
If PEB was lucky enough to get 5% of the total cases (100,000 + (40,000 x 2)) 180,000 tests @ 750.00US makes for USD135,000,000
By the way things are going there would be a requirement for additional lab space if this played out.
Interesting times but I wouldnt hang my hat on getting 5.7 million patients in a hurry.

This also raises the question as to what the other 95% are using for tests
Cheers
Miner

[calledone]

Thanks guys for the clarifications. The “medically necessary” term threw me off my expectations I had prior to this news lol. But very significant news nonetheless!

[Leftfield]

Whew! Some parts are right, mate.
You are about right with the total that United is 4 times bigger than Kaiser (and thus nearly equivalent to CMS)

Doubtful there is any intention to test patients for bladder cancer as a screening process generally overall.
cxBladder Triage will be useful for persons presenting with haematuria to rule out bladder cancer.
So therefore there would have to be some possible symptoms appearing first.
Apparently there are some 2,000,000 presentations for that in the entire US medical scene annually.
There are also some 800,000 patients requiring ongoing monitoring for recurrence following a bladder cancer operation.
These are in some cases carried out 2 or 3 times a year over 5 years
If PEB was lucky enough to get 5% of the total cases (100,000 + (40,000 x 2)) 180,000 tests @ 750.00US makes for USD135,000,000
By the way things are going there would be a requirement for additional lab space if this played out.
Interesting times but I wouldnt hang my hat on getting 5.7 million patients in a hurry.

This also raises the question as to what the other 95% are using for tests
Cheers
Miner

Miner, just wanted to say that over many years you have shared a lot of useful info' on PEB (not without some acrimony from some quarters at times.) Many of us are 'well positioned' thanks to your efforts. My sincere thanks.

ps can't help thinking 10% market share is possible/achievable for PEB, but it won't happen overnight. Exciting times.

[Minerbarejet]

Possibly interpret it as " was it medically necessary" (paying out on a test already done) rather than "is it medically necessary" for a test about to be utilized.

[Leftfield]

This should create some additional momentum, I've held on for many years and starting to see some great returns now - my only regret is that I sold a small parcel of shares for a very small profit a couple of years ago. The succession of good news bodes well in the event of an eventual takeover.

Regrets are a good learning opportunity IMHO. If your DCA SP is now looking sound, it may be a good strategy to add more. Ride your winners and keep a 'safety margin' with a lower DCA.

Disc - Holding at a DCA of 61c and adding on any good news.

[sunnysleeper11]

Also remember men and women are affected differently with bladder cancer
In 2019 men had 61,700 cases of bladder cancer, compared to only 18,770 in women (Cxbladder info)
United Healthcare - 5.7m people able to have the test.
2.8 men v 2.8 women approx.

[Minerbarejet]

Miner, just wanted to say that over many years you have shared a lot of useful info' on PEB (not without some acrimony from some quarters at times.) Many of us are 'well positioned' thanks to your efforts. My sincere thanks.

ps can't help thinking 10% market share is possible/achievable for PEB, but it won't happen overnight. Exciting times.

Thank you but I was fortunate to establish an ongoing email relationship with the founder of this thread (no not Gryffn) who has been the guiding light on the published information coming forth from PEB over the years.
Consequently most of the kudos should be directed there. I know he does keep up to date with ST.

[Moneyman]

The upside in PEL from here is unrivalled on the NZX and the downside risk is reducing with each announcement. PEL has significantly more upside than PPH yet it’s market cap is c 1/3 of PPH.

Largest holding and continuing to accumulate with each announcement.

[psychic]

More smoke and mirrors from Pacific Edge I say.

United has its own healthcare plans AND a Medicare plan - it jockeys the CMS Medicare coverage and CMS are the primary Payer.
The inclusion of the Cxbladder CPT codes seem to me to be under the Medicare plan, not United's own plans. Inclusion of the CPT code does not imply coverage, but obviously their medicare policy needs to be updated to reflect the inclusion by CMS.

Cxbladder is covered by Medicare when "medically necessary". But until such time as the American Urological Assn review it's determination on the use of Urinary Biomarkers, the use of Cxbladder is not recommended (last review effective Jan 2021), and unlikely "medically necessary".

[Minerbarejet]

Undoubtedly the rate of payments from CMS in the coming few weeks will be of great interest to the AUA as well and give guidance to them that they are not the only ones who can assess whether something is medically necessary or not.

Not recommended by them does not mean that various medical centres cant use CXBladder and cannot assess for themselves if it is of value.

This might help

https://www.cxbladder.com/nz/news/2019/us-clinical-review-reinforces-need-for-cxbladder-in-hematuria-guidelines/

Contained within this is the following statement regarding AUA guidelines.

The AUA guidelines generated 5.3-times more radiation induced cancers than the KP guidelines. (575 vs 108).

I would deem this not medically necessary wouldnt you?

[psychic]

Undoubtedly the rate of payments from CMS in the coming few weeks will be of great interest to the AUA as well and give guidance to them that they are not the only ones who can assess whether something is medically necessary or not.

Not recommended by them does not mean that various medical centres cant use CXBladder and cannot assess for themselves if it is of value.

This might help

https://www.cxbladder.com/nz/news/2019/us-clinical-review-reinforces-need-for-cxbladder-in-hematuria-guidelines/

Contained within this is the following statement regarding AUA guidelines.

The AUA guidelines generated 5.3-times more radiation induced cancers than the KP guidelines. (575 vs 108).

I would deem this not medically necessary wouldnt you?

This review seems to be based on 2012/2013 clinical guidelines, Cxbladder unlikely to have been a contributor to the KP score?
But regardless, clearly the goal is to work toward a better, cheaper, faster and less invasive method of diagnosis - no arguments there. You will note that the AUA guidelines missed detection of the fewest number of cancers, a fairly important consideration also no?

The rate of payments from CMS might be of interest to the AUA but I think will be of greater interest to Shareholders here if they are not as forthcoming as you assume. We have zero actual evidence of significant clinical use or payment by either KP or CMS yet, we will both see in May I guess.

But my post was more about United, and whether US Insurers were starting to cover Cxbladder. I say they are not. This latest announcement only modifies United's Medicare Policy in tune with the Medicare cover.

[Minerbarejet]

I assumed nothing.
I said it will be interesting to see what the rate of uptake was in the last six months.

Perhaps there is something more to this sudden revelation by United that cxBladder usage in their Medicare Advantage plan will be honoured with payment.
I would consider the possibility that this was not the case until Mid March.
Now all United patients over 65 using cxBladder will have their claim honoured whereas they weren't before.

Some further input just became available

"I will let these PhDs and MD’s: and their publication from July 2019 speak for itself, their affiliations are identified too.

Mihaela V. Georgieva, PhD1 (https://jamanetwork.com/searchresults?author=Mihaela+V.+Georgieva&q=Mihaela+V.+Georgieva); Stephanie B. Wheeler, PhD, MPH1,2 (https://jamanetwork.com/searchresults?author=Stephanie+B.+Wheeler&q=Stephanie+B.+Wheeler); Daniel Erim, MD, PhD, MSc3 (https://jamanetwork.com/searchresults?author=Daniel+Erim&q=Daniel+Erim); Rebecca Smith-Bindman, MD, MPH4 (https://jamanetwork.com/searchresults?author=Rebecca+Smith-Bindman&q=Rebecca+Smith-Bindman); Ronald Loo, MD5 (https://jamanetwork.com/searchresults?author=Ronald+Loo&q=Ronald+Loo); Casey Ng, MD5 (https://jamanetwork.com/searchresults?author=Casey+Ng&q=Casey+Ng); Tullika Garg, MD, MPH6 (https://jamanetwork.com/searchresults?author=Tullika+Garg&q=Tullika+Garg); Mathew Raynor, MD7 (https://jamanetwork.com/searchresults?author=Mathew+Raynor&q=Mathew+Raynor); Matthew E. Nielsen, MD, MS1,2,7,8,9 (https://jamanetwork.com/searchresults?author=Matthew+E.+Nielsen&q=Matthew+E.+Nielsen)

Author Affiliations
· 1Department of Health Policy and Management, University of North Carolina Gillings School of Global Public Health, Chapel Hill
· 2University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill
· 3Division of eHealth, Quality and Analytics, Social Policy, Health and Economics Research Unit, RTI International, Research Triangle Park, North Carolina
· 4Departments of Radiology, Epidemiology and Biostatistics, University of California at San Francisco, San, Francisco
· 5Department of Urology, Kaiser Permanente Southern California, Los Angeles, California
· 6Department of Urology, Geisinger Health, Danville, Pennsylvania
· 7Department of Urology, University of North Carolina School of Medicine, Chapel Hill
· 8Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill
· 9Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon

And their article referred to on the CxBladder site : US Clinical Review Reinforces Need for Cxbladder in Hematuria Guidelines.


HyperLink: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2739056"

[psychic]

I assumed nothing.
I said it will be interesting to see what the rate of uptake was in the last six months.

Perhaps there is something more to this sudden revelation by United that cxBladder usage in their Medicare Advantage plan will be honoured with payment.
I would consider the possibility that this was not the case until Mid March.
Now all United patients over 65 using cxBladder will have their claim honoured whereas they weren't before.

Yes, Medicare tests covered if those tests are "medically necessary" .

I see the NCCN clinical practice guidelines have been reviewed also, effective April 1st. Nothing in there to direct Urologists toward the use of Cxbladder or tumour markers at all. So in using a Cxbladder test, Urologists are not following the recommendations of the AUA or NCCN.

I wonder, how do Urologists demonstrate that the use of a Cxbladder test is "medically necessary" if not recommended by clinical guidelines and National bodies. If they cannot, then is the test then merely investigational and not covered? A bit like all those thousands of CMS tests completed over the years that Pacific Edge pretend they will now be reimbursed for?

Again, I do not think this is a change that United have instigated. They are simply updating their medicare policy so that it reflects what is covered by CMS.

[psychic]

Does this study recommend Cxbladder somehow Miner?

[Minerbarejet]

Does this study recommend Cxbladder somehow Miner?
Its about risk stratification from do nothing to Full blown AUA Cystoscopy and Imaging.
It would appear that cxbladder would fit rather well into a cost/benefit ratio based on these findings.

[winner69]

Haha. Your question #1 is very wise and proves that nobody should necessarily believe everything they read on ST.

A $5.00 SP is my just reward for backing the company through thick and thin for the past nine years, including supporting numerous cash raises and coping with all the angst and BS on this site!

.

Jeez Pierre, only nine years ..I have a mate whose held through thick and thin etc for 17 years

He deserves more than 5 bucks eh

I’ve had a few adventures with PEB over the years .....best was seling in the 150s

[psychic]

Its about risk stratification from do nothing to Full blown AUA Cystoscopy and Imaging.
It would appear that cxbladder would fit rather well into a cost/benefit ratio based on these findings.

You might think it would "appear" Cxbladder would fit in, but the study does not suggest that and misleading to suggest the Authors do.

[psychic]

Jeez Pierre, only nine years ..I have a mate whose held through thick and thin etc for 17 years

He deserves more than 5 bucks eh

I’ve had a few adventures with PEB over the years .....best was seling in the 150s

A lot less shares on issue back in those days though eh Winner. Still, heady days..


Crazy how the market says Fridays announcement worth $175m change in mcap . Had to be brought to PE attention 9 days after the event and then it seems it really was not as material as Dave made out..

[Minerbarejet]

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=58529&ver=3&lcdid=35396&keyword=Cxbladder&keywordType=sta

Read the response to the cx bladder topic

It comes under necessary in the Social Security Act which would probably have more clout than the AUA

[psychic]

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=58529&ver=3&lcdid=35396&keyword=Cxbladder&keywordType=sta

Read the response to the cx bladder topic

It comes under necessary in the Social Security Act which would probably have more clout than the AUA

Oh, I did! But I'm not sure I really understood it! The response says:

Thank you for your comments, the CxBladder test is now covered utilizing the reasonable and necessary guidelines as outlined in Title XVIII of the Social Security Act, Section 1862(a)(1)(A) which states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Therefore, CxBladder is not addressed in the LCD or billing and coding article.

It makes sense that the 1862 Act would prevent Medicare from paying for any services that are not reasonable and necessary.
If it is reasonable and necessary then it is covered, but the Act does not decide this. And "therefor cxbladder is not addressed in the LCD?
What is your interpretation of that?

[psychic]

The following I copied from the CMS site, it is the proposed LCD I think being discussed
Proposed Local Coverage Determination (LCD):
Biomarkers for Oncology (DL35396)

Consistent with the NCCN rating and literature review, the following Biomarker Panel will continue to be considered not medically reasonable and necessary:

CXBLADDER
NCCN Guidelines 4.201988 Bladder Cancer, for cTa high grade, cT1, and Tis, follow-up is recommended with a urinary cytology and cystoscopy at 3 to 6 month intervals for the first 2 years, and at longer intervals as appropriate thereafter. Imaging of the upper tract should be considered every 1 to 2 years for high-grade tumors (see Follow-up algorithm). Urine molecular tests for urothelial tumor markers are now available.88(p68)
Follow-up urine cytology every 3 months and consider urinary urothelial tumor markers (category 2B) for high risk, non-muscle-invasive bladder cancer at year one and annually up to 10 years and then as clinically indicated. Molecular/genomic testing should include analysis by RT-PCR for FGFR3 or FGFR2, and for FGFR, RGQ.88(p79)

As one can see when molecular/genomic testing mentioned in the NCCN Guidelines Version 4.2019 Bladder cancer, there is no shared commonality in the CXBLADDER test and the genetic alterations that should be included by NCCN guidelines, and even those mentioned in NCCN guidelines, are a 2B level of recommendation.

Davidson PJ, et al. (2019),89 is an observational cohort study conducted in New Zealand. The addition of CxBT to the routine investigation of hematuria was carried out following consensus between local clinicians. No other change to clinical practice was made and there was no randomization or control group. The review did not require ethical approval, as it constituted monitoring and improvement of usual patient care carried out by the Canterbury DHB.163 No blinding with diagnosis based on histology and cystoscopy. The results were the development of theoretical pathway. The patients were coached in the test and what it meant. This was carried out within one health board district in New Zealand with little follow-up. The limitation is a mandatory protocol pathway and no documented clinical utility, but healthcare insurer utility. The generalizability to the Medicare population was not specified. Seven year mean difference in patients not referred and referred patients with the older group referred to urologist. Nine year medial age difference. Proposed pathway for less than one year of data is not enough data to support a change of decision.
Konety B, et al. (2019),90 is a retrospective study of pooled data from three prospective clinical trials and one real world clinical study in which 1784 patients with hematuria or previously diagnosed UC provided 852 samples. According to the authors, CXBLADDER ruled out 35% of patients and NPV of 97% compared to 93% for cytology. CXBLADDER correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy and outperformed cytology for accurately identifying patients who do not have UC.162 The limitation is this was open access and not peer reviewed with a significant conflict of interest by the authors. Clinical utility is not part of this study and was only theorized. The generalizability to the Medicare population was not specified in the original article. However, in the supplemental table 3, the age in each study was given but not in relationship to the findings. The clinical utility was not documented.

[psychic]

Consistent with the NCCN rating and literature review, the following Biomarker Panel will continue to be considered not medically reasonable and necessary:

CXBLADDER

[psychic]

and this:

CXBLADDER

The literature submitted for the requested addition of the CXBLADDER panel was carefully reviewed. After consideration of the literature, NCCN rating, and relevance to the Medicare population, the CXBLADDER panel will continue to be non-covered at this time. The molecular/genomic testing mentioned in the NCCN Guidelines for Bladder cancer shared no commonality in the CXBLADDER test and the genetic alterations that should be included by NCCN guidelines. Additionally, those genomic/molecular tests mentioned in the NCCN guidelines only achieved a 2B level of recommendation. Further, the clinical utility and clinical validity was not supported in the literature and was not generalizable to the Medicare population.

[Minerbarejet]

Oh, I did! But I'm not sure I really understood it! The response says:

Thank you for your comments, the CxBladder test is now covered utilizing the reasonable and necessary guidelines as outlined in Title XVIII of the Social Security Act, Section 1862(a)(1)(A) which states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Therefore, CxBladder is not addressed in the LCD or billing and coding article.

It makes sense that the 1862 Act would prevent Medicare from paying for any services that are not reasonable and necessary.
If it is reasonable and necessary then it is covered, but the Act does not decide this. And "therefor cxbladder is not addressed in the LCD?
What is your interpretation of that?

Therefore in order for CMS to be making payments (which we are led to believe they are) the test must have been confirmed as reasonable and necessary otherwise they wouldn't be paying out, being bound by the Social Security Act

It is not addressed in the article because it was already in place and had been accepted is how I would interpret that.

[Moneyman]

When a test is done in the US the urologist is required to declare that the test is “medically necessary” this form is then provided with the reimbursement application.

[Snow Leopard]

I think I am confused:

So was the 2020 CMS LCD for a MAC (Novitas in Jurisdiction L, for Parts A & B only [ obviously :) ]) or nationally (which is what it appears to say)?

If the latter why does the UHC thing make a difference such that the ANN (announcement) was marked price sensitive?
& if the former was that ANN TBS?
and if it was TBS is this new ANN TBS also?

Do I not understand it?
Does PEB not understand it?
Where is the wine bottle?

Is this post both reasonable and necessary?

Disc: happy holder + healthy (HH+H)

[calledone]

I think I am confused:

So was the 2020 CMS LCD for a MAC (Novitas in Jurisdiction L, for Parts A & B only [ obviously :) ]) or nationally (which is what it appears to say)?

If the latter why does the UHC thing make a difference such that the ANN (announcement) was marked price sensitive?
& if the former was that ANN TBS?
and if it was TBS is this new ANN TBS also?

Do I not understand it?
Does PEB not understand it?
Where is the wine bottle?

Is this post both reasonable and necessary?

Disc: happy holder + healthy (HH+H)

Sorry what is TBS? Anyway good point and equally confused now lol. Maybe Balance can add some balance here!

[Snow Leopard]

Sorry what is TBS? Anyway good point and equally confused now lol. Maybe Balance can add some balance here!

Total Bull S...

[calledone]

I think I am confused:

So was the 2020 CMS LCD for a MAC (Novitas in Jurisdiction L, for Parts A & B only [ obviously :) ]) or nationally (which is what it appears to say)?

If the latter why does the UHC thing make a difference such that the ANN (announcement) was marked price sensitive?
& if the former was that ANN TBS?
and if it was TBS is this new ANN TBS also?

Do I not understand it?
Does PEB not understand it?
Where is the wine bottle?

Is this post both reasonable and necessary?

Disc: happy holder + healthy (HH+H)

Actually after going through the approval announcements, looks like the CMS announcement last year was a national approval while individual insurers will need to approve within their organisation for reimbursement to go through. If that is the case then both announcements are valid and positively significant.

[kiora]

IF I was a shareholder what would be significant would be the money.
PEB have not updated any financial results recently.

[Brain]

I am very positive about the prospects for PEB. They are making good progress


“more than 110 million Americans now have coverage of Cxbladder non-invasive, highly accurate tests for the detection and management of urothelial and bladder cancer.”

And from the last annual report

“Our tests can be used for the more than 3.4 million people in the USA who present to the physician with blood in their urine and are required to be evaluated for bladder cancer each year. There are also more than 800,000 who are living with the disease and who require regular monitoring for recurrence, up to 4x per year for up to five years, giving rise to an approximate 3.2 million further clinic visits. Approximately 4 million cystoscopies were performed in 2018, many of which have now been shown to be able to be safely replaced with Cxbladder.”


The technical hurdles seem to be over and now it’s reliant on a sales effort and if the insurers can save money then that has got to be a significant tail wind.

[winner69]

I think PEDUSA is a cool sounding name for a company.

[psychic]

I am very positive about the prospects for PEB. They are making good progress


“more than 110 million Americans now have coverage of Cxbladder non-invasive, highly accurate tests for the detection and management of urothelial and bladder cancer.”

And from the last annual report

“Our tests can be used for the more than 3.4 million people in the USA who present to the physician with blood in their urine and are required to be evaluated for bladder cancer each year. There are also more than 800,000 who are living with the disease and who require regular monitoring for recurrence, up to 4x per year for up to five years, giving rise to an approximate 3.2 million further clinic visits. Approximately 4 million cystoscopies were performed in 2018, many of which have now been shown to be able to be safely replaced with Cxbladder.”


The technical hurdles seem to be over and now itÂ’s reliant on a sales effort and if the insurers can save money then that has got to be a significant tail wind.




Can be used is not the same as will be used. It would be terrific to believe that Cxbladder could replace many of these 4000 cystoscopies each year but how many is the thing. This report considering adoption I think suggests not so many...

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656863/

The technical hurdles I think may be far from over and adoption still cautious and slow. Are the tests high rate of false positives and unecessary follow up the issue? Is it a question over validity and the tests usefulness being confined to a narrow band of cases?

[winner69]

I think I am confused:

So was the 2020 CMS LCD for a MAC (Novitas in Jurisdiction L, for Parts A & B only [ obviously :) ]) or nationally (which is what it appears to say)?

If the latter why does the UHC thing make a difference such that the ANN (announcement) was marked price sensitive?
& if the former was that ANN TBS?
and if it was TBS is this new ANN TBS also?

Do I not understand it?
Does PEB not understand it?
Where is the wine bottle?

Is this post both reasonable and necessary?

Disc: happy holder + healthy (HH+H)

Jeez snowy, if you seem a bit confused than things must be confusing

Experience over 17 years of following PEB I still think that the likes of Darling are still confused as well.

Seems a lot clutching at comforting falsehoods and as a consequence doing some motivated reasoning on this thread lately..... or more simply put 'wishful thinking'

I can say these things because I have given PEB a lot of cash over the years (capital raises) so feel more of an owner than many who have just bought shares of somebody else.

But as long as punters feel optimistic and pump the price up every now again who cares.

[pierre]

Can be used is not the same as will be used. It would be terrific to believe that Cxbladder could replace many of these 4000 cystoscopies each year but how many is the thing.
The report suggested 4m cytoscopies, NOT 4k, so quite different numbers. Just 5% of those 4m results in 200k tests and at USD750 each that produces revenue of USD150m. Doesn't seem like an impossible target to reach.
However, I understand your concerns, so I guess PEB should not be on your investment radar.

[Minerbarejet]

Can be used is not the same as will be used. It would be terrific to believe that Cxbladder could replace many of these 4000 cystoscopies each year but how many is the thing. This report considering adoption I think suggests not so many...

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656863/

The technical hurdles I think may be far from over and adoption still cautious and slow. Are the tests high rate of false positives and unecessary follow up the issue? Is it a question over validity and the tests usefulness being confined to a narrow band of cases?
Quite right Pierre.
Big difference.

[calledone]

"It adds further validation of Cxbladder and a point of inflexion for other healthcare insurers."

Does the above comment from DD mean that in the insurance business, smaller insurers will have to follow the big boys?

[Brain]

"It adds further validation of Cxbladder and a point of inflexion for other healthcare insurers."

Does the above comment from DD mean that in the insurance business, smaller insurers will have to follow the big boys?

The insurers will do what’s best for the insurers.

[pierre]

The insurers will do what’s best for the insurers.
In which case they should fund CxBladder - however they are highly unlikely to direct medical specialists as to which test they should use with their patients.

[psychic]

The report suggested 4m cytoscopies, NOT 4k, so quite different numbers. Just 5% of those 4m results in 200k tests and at USD750 each that produces revenue of USD150m. Doesn't seem like an impossible target to reach.
However, I understand your concerns, so I guess PEB should not be on your investment radar.

A typo error I'm sorry, but the overall number was not the point I was trying to make.

[Minerbarejet]

Which option would you take if you suddenly started peeing blood.

A. Take a cxBladder test?

B. Go for a camera up your whizzer plus imaging?

You are the patient and you have the choice available

[Brain]

Which option would you take if you suddenly started peeing blood.

A. Take a cxBladder test?

B. Go for a camera up your whizzer plus imaging?

You are the patient and you have the choice available

And you can take the test/sample at home which for most is a huge plus. It is hard for me not to be optimistic about the long term prospects for PEB.

[pierre]

And you can take the test/sample at home which for most is a huge plus. It is hard for me not to be optimistic about the long term prospects for PEB.
Me too. I don't think Psychic is quite living up to his name. 🤣

[Brain]

A typo error I'm sorry, but the overall number was not the point I was trying to make.

PEB only need about 30,000 tests to break even( very rough calc ) so PEB can make a good living on the crumbs that fall off the table. If they do better which I expect they will because of the points that miner has made then this will be a seriously profitable business.

[Minerbarejet]

Pertinent and informative.

https://www.washingtonpost.com/national/health-science/how-much-to-worry-about-the-radiation-from-ct-scans/2016/01/04/8dfb80cc-8a30-11e5-be39-0034bb576eee_story.html


Does "First, do no harm" apply here?

Cheers
Miner

[Retired Doc]

Pertinent and informative.

https://www.washingtonpost.com/national/health-science/how-much-to-worry-about-the-radiation-from-ct-scans/2016/01/04/8dfb80cc-8a30-11e5-be39-0034bb576eee_story.html


Does "First, do no harm" apply here?

Cheers
Miner

Very much “Primum non nocere” Miner

[psychic]

Which option would you take if you suddenly started peeing blood.

A. Take a cxBladder test?

B. Go for a camera up your whizzer plus imaging?

You are the patient and you have the choice available

Sadly simple personal choice won't be the making of Cxbladder Miner. Getting this across the line has been a little more complicated than that as you well know. BTW, Triage only looked great with imaging along side right?

[Minerbarejet]

Sadly simple personal choice won't be the making of Cxbladder Miner. Getting this across the line has been a little more complicated than that as you well know. BTW, Triage only looked great with imaging along side right?
In the context of Triage application there is a condition/symptom that requires investigation.

A cx bladder test can provide information on whether there is an indication of cancer or not.

If the result is positive or requiring investigation the imaging provides the information as to location and where to start looking.


However, in the Monitor situation the patient has had a bladder cancer operation already and is on the way to recovery.

After a couple of rounds of investigative cystoscopies and imaging with all clear results would it not seem appropriate to turn to a non invasive test such as cxBladder?

Why continue to bombard the poor sod with no symptoms with regular 3monthly painful and invasive cystoscopies plus a dose of radiation which could possibly lead to either new (gasp) bladder cancer or cancer in other locations.

Dissonance or reluctance to participate may start wandering in as well resulting in less than satisfactory outcomes.

Looks to me like this overkill may be in future times be considered as reckless endangerment when a viable alternative is available in the Monitor situation.

Would be very interested to know if the rate of recurrence of bladder cancer ( around 70%) is made worse by the use of imaging which is what the article was about.

Disclaimer: I am not in any way connected to the medical profession but have since climbing aboard Pacific Edge all those years ago made it my business to research most of the available detail in the public domain and to form my own opinions, right or wrong.

[silu]

Out of curiosity. What is the highest Market Capitalization PEB ever achieved? Hard to figure out with all the dilution over the years.

[winner69]

Out of curiosity. What is the highest Market Capitalization PEB ever achieved? Hard to figure out with all the dilution over the years.

Morningstar data had market cap at 430m in 2014

Hard to believe that PEB is almost a billion dollar company today eh

[silu]

Morningstar data had market cap at 430m in 2014

Hard to believe that PEB is almost a billion dollar company today eh

Thank you. I was briefly a shareholder in 2013 but sold quickly after a 15% drop. However, now this looks like a complete different beast. I have no experience in this sector at all but someone told me (and I hope this still rings trues) about US healthcare providers "Once you're in you're in".

[Greekwatchdog]

DD to retire next year - https://www.nzx.com/announcements/370510

[Balance]

DD to retire next year - https://www.nzx.com/announcements/370510

Hmmmm - itching to get rid of all the shares he has accumulated?

[Greekwatchdog]

LOL Your a cynic..12 Months notice.

[jimdog31]

Hmmmm - itching to get rid of all the shares he has accumulated?

Hmmm is right.

[Greekwatchdog]

For Bars updated this morning. No change to target price
OUTPERFORM
Pacific Edge (PEB) announced coverage from United Healthcare, the largest US private health insurer — another important
external validation in the key US market for its bladder cancer tests. The market opportunity is extensive and we see PEB as
well positioned to capitalise on this. There is no short-cut to changing clinical practice and the hard work is far from over,
however, recent key milestones have helped to prove up the commercial model and lower the risk. With the range of
justifiable long-term outcomes wide, we expect the share price to continue to be driven by newsflow — which is likely to be
positively skewed as further commercial progress follows recent success. OUTPERFORM.
Recent commercial milestones in the key US market
We have no visibility on price, however, expect both will be above that of public health insurer, CMS (price of US$760/test).
No change to forecasts, but helps to provide further confidence in medium-term outlook
We have not made any changes to our forecasts; our base case already incorporates progress with private insurers. However, as PEB
continues to make further commercial progress this helps to increase our confidence in the revenue path, and lower the risk. Being ‘in
network’ (or under coverage) with US payors will materially speed up the time to cash collection and reduce leakage (where cash is
never collected). This should also see test numbers better match revenue in time.
Share price responsive to newsflow
PEB's share price is highly responsive to newsflow, with the strong spike post the United Healthcare announcement returning the
stock to its recent high (late December 2020) after a period of steady decline. The path from here will unlikely be straight, however,
we expect newsflow to be positively skewed. This includes: new commercial agreement(s), stronger mention/inclusion in clinical
guidelines, back payment from US public health insurer CMS (for tests done ahead of securing reimbursement), additional.

[winner69]

Hmmmm - itching to get rid of all the shares he has accumulated?

Hey balance - We should make a list of his most famous davidisms and put them in a farewell card.

Remember when he used 'exciting' 22 times in one announcement

[sunnysleeper11]

Hmmmm - itching to get rid of all the shares he has accumulated?

yep - and so he should
he's done quite an extraordinary job with this company

[winner69]

Forbar finally caught on to the game -- PEB's share price is highly responsive to newsflow,

yep, instos ring Dave up and say 'hey Dave, share price declining so put out another announcement, even if its just what you said before but said in another way ... as long as its positive.@

[calledone]

How old is DD?

[winner69]

How old is DD?

I'd goes mid to late 50's

Maybe he's going back to Arborgen

[Balance]

Hey balance - We should make a list of his most famous davidisms and put them in a farewell card.

Remember when he used 'exciting' 22 times in one announcement

In all seriousness, why would any CEO leave a company just ‘when’ it is on the verge of real glory?

Must say it has got me scratching my head and evaluating my position.

Change ‘when’ to ‘if’ maybe?

[winner69]

In all seriousness, why would any CEO leave a company just ‘when’ it is on the verge of real glory?

Must say it has got me scratching my head and evaluating my position.

Change ‘when’ to ‘if’ maybe?

That was my first thought as well

[calledone]

In all seriousness, why would any CEO leave a company just ‘when’ it is on the verge of real glory?

Must say it has got me scratching my head and evaluating my position.

Change ‘when’ to ‘if’ maybe?

The news said he will continue in a consultation role after stepping down as CEO, so he may not be leaving as just yet. Anyway the retirement as CEO is in April 2022.

[BigBob]

In all seriousness, why would any CEO leave a company just ‘when’ it is on the verge of real glory?

Must say it has got me scratching my head and evaluating my position.

Change ‘when’ to ‘if’ maybe?

It has often been said that his main skills are in raising capital - maybe those skills are not needed anymore...

[Balance]

It has often been said that his main skills are in raising capital - maybe those skills are not needed anymore...

Good point to consider.

[psychic]

Smoke and mirrors won't fool the faithful by May 2022 when results are published. There will be unhappiness and disbelief next month with the publication of the 2021 results but Dave will have worked out excuses for those. But not next year. A year to sell down. All good.
CxB will then be taken out by big Pharma and become Gold standard. How's that?
He's done an incredible job keeping the wheels on till now.

[Greekwatchdog]

If people are expecting a profit this financial year they are deluded and should get out.

[Balance]

If people are expecting a profit this financial year they are deluded and should get out.

Agreed.

What will be of critical interest will be the uptake of tests since LCD was granted, snd stage of collection of the CMS backlog receivables of US$40m.

[psychic]

Profit?!! What's that? No, it'll be test throughput and revenue growth that'll disappoint.

[Balance]

Profit?!! What's that? No, it'll be test throughput and revenue growth that'll disappoint.

Let’s wait for the results, shall we before anyone passes judgement.

[Baa_Baa]

Profit?!! What's that? No, it'll be test throughput and revenue growth that'll disappoint.

Do they have a 'back office & lab' testing process (send to base, test, send result) that can scale to 10's or 100's of thousands of tests?

[Leftfield]

DD to retire next year - https://www.nzx.com/announcements/370510

Unsettling for holders, but the 12 months notice should calm nerves a little.

[silu]

Unsettling for holders, but the 12 months notice should calm nerves a little.

Hmm I did buy back in this morning before I read the CEO has announced his retirement. And I thought there may be a wave of goodwill riding today based on last week's announcement.

[Leftfield]

Hmm I did buy back in this morning before I read the CEO has announced his retirement. And I thought there may be a wave of goodwill riding today based on last week's announcement.

Ouch - Tough call. Sudden changes/news like this is why I prefer to buy in increments over time and take advantage of DCA. Wish you well.

(FWIW I bought more last Fri on the good news, however my DCA is well below today's SP. I'm going to continue holding and use next results to inform any changes.)

ps can't help comparing to today's SML news re their CEO. I much prefer the way PEB is managing the transition. Next PEB CEO may well come out of USA?? Interesting times ahead.

[Minerbarejet]

Do they have a 'back office & lab' testing process (send to base, test, send result) that can scale to 10's or 100's of thousands of tests?

They apparently have the capacity for 200,000 tests PA.
Nobody is expecting them to be in profit but they are now getting CMS payments and will have some input from Kaiser since the last HY.
How much remains to be seen and it will be interesting to see if the PIHSS system has produced during the Covid crisis
Any kind of reasonable reduction in operating losses would be welcome.

[winner69]

Thank you but I was fortunate to establish an ongoing email relationship with the founder of this thread (no not Gryffn) who has been the guiding light on the published information coming forth from PEB over the years.
Consequently most of the kudos should be directed there. I know he does keep up to date with ST.

How is Bryan these days?

Or am I mistaken

[Brain]

Dave’s done a great job getting it this far. A years notice is good and gives PEB a good length of time to find a replacement with the right skills for the next stage of growth. Dave’s replacement will look at the business with fresh eyes.

[jridler]

18 years is a long time at the helm. DD will be well taken care of in retirement with his 8.7m shares. I see it as a positive - the company is at a new stage in its evolution and the leadership should reflect this.

[silu]

Ouch - Tough call. Sudden changes/news like this is why I prefer to buy in increments over time and take advantage of DCA. Wish you well.

(FWIW I bought more last Fri on the good news, however my DCA is well below today's SP. I'm going to continue holding and use next results to inform any changes.)

ps can't help comparing to today's SML news re their CEO. I much prefer the way PEB is managing the transition. Next PEB CEO may well come out of USA?? Interesting times ahead.

The money I've put into PEB is money I could afford to lose (not that I want to). I know nothing about Biotech and my foray into 2 ASX companies have been a disaster. I'm in a similar boat as you and usually only buy a small stake in high-risk investments but add more if the investment has been de-risked or a path to sustainable growth has been cleared out.

I know nothing of the existing CEO but sometimes the change of a CEO can have an exciting effect on a company if it enters a different phase. I read before that the current CEO is a master of fund raising so maybe the new CEO has experience in the US healthcare sector and knows how to grow sales? Cxbladder is such a mature and exciting prospect PEB should be able to attract a high calibre of CEO right?

Either way I truly hope that PEB will become a NZ investing success story. Our financial market needs great NZ companies that can grow and take on the world.

[winner69]

We'll probably have to pay the new CEO heaps more than the $600k odd that David was getting

[jimdog31]

We'll probably have to pay the new CEO heaps more than the $600k odd that David was getting


Pay peanuts, get ......

[winner69]

Pay peanuts, get ......

...hope you not saying that's been one of the problems with PEB over the years

[thegreatestben]

I think it's good, 18 years is a long time in the saddle. Very healthy decision to know when to step back and enjoy your hard work.
The next CEO will likely have the skills to take PEB to the next level. The next 12 months aren't going to be stellar but maybe an opportunity to buy some more at bargain prices when results disapoint.

[jimdog31]

...hope you not saying that's been one of the problems with PEB over the years

haha. With their market cap where it is , and supposedly heading, Id say they need to be paying more to get more.

[Minerbarejet]

How is Bryan these days?

Or am I mistaken
Im sure Bryan is fine these days - whoever he is.
Lol

[glenscape]

For Bars updated this morning. No change to target price
OUTPERFORM
Pacific Edge (PEB) announced coverage from United Healthcare, the largest US private health insurer — another important
external validation in the key US market for its bladder cancer tests. The market opportunity is extensive and we see PEB as
well positioned to capitalise on this. There is no short-cut to changing clinical practice and the hard work is far from over,
however, recent key milestones have helped to prove up the commercial model and lower the risk. With the range of
justifiable long-term outcomes wide, we expect the share price to continue to be driven by newsflow — which is likely to be
positively skewed as further commercial progress follows recent success. OUTPERFORM.
Recent commercial milestones in the key US market
We have no visibility on price, however, expect both will be above that of public health insurer, CMS (price of US$760/test).
No change to forecasts, but helps to provide further confidence in medium-term outlook
We have not made any changes to our forecasts; our base case already incorporates progress with private insurers. However, as PEB
continues to make further commercial progress this helps to increase our confidence in the revenue path, and lower the risk. Being ‘in
network’ (or under coverage) with US payors will materially speed up the time to cash collection and reduce leakage (where cash is
never collected). This should also see test numbers better match revenue in time.
Share price responsive to newsflow
PEB's share price is highly responsive to newsflow, with the strong spike post the United Healthcare announcement returning the
stock to its recent high (late December 2020) after a period of steady decline. The path from here will unlikely be straight, however,
we expect newsflow to be positively skewed. This includes: new commercial agreement(s), stronger mention/inclusion in clinical
guidelines, back payment from US public health insurer CMS (for tests done ahead of securing reimbursement), additional.
In a research note released today, Forsyth Barr gave Pacific Edge an outperform tag, with a target price of $1.60, up from its last close of $1.2 a share.
Forsyth Barr senior analyst Chelsea Leadbetter said the bladder cancer test market opportunity was extensive and Pacific Edge was well positioned to capitalise on it.
“There is no shortcut to changing clinical practice and the hard work is far from over, however, recent key milestones have helped to prove up the commercial model and lower the risk.”
https://www.nbr.co.nz/story/pacific-edge-ceo-plans-retirement-following-strong-run

[jridler]

I think it's good, 18 years is a long time in the saddle. Very healthy decision to know when to step back and enjoy your hard work.
The next CEO will likely have the skills to take PEB to the next level. The next 12 months aren't going to be stellar but maybe an opportunity to buy some more at bargain prices when results disapoint.
Interested to understand more regarding your statement of "the next 12 months aren't going to be stellar". Is this in respect of the share price, company performance, or both?

[jridler]

We'll probably have to pay the new CEO heaps more than the $600k odd that David was getting
DD received 432k for FY2020 as per annual report.

[silu]

DD received 432k for FY2020 as per annual report.

That's cheap. One of the companies in the sector I'm holding pays their CEO over NZ$1m + share options. But then he came with an impressive CV and has a silver tongue and great presentation skills which (unfortunately) opened my purse strings.

[winner69]

DD received 432k for FY2020 as per annual report.

Your right

I just looked at the table of remuneration over $100k and top one was 620k

So poor old David has 3 people earning more than him ...prob Jackie and others at PEDUSA

[Lion_graf]

In a research note released today, Forsyth Barr gave Pacific Edge an outperform tag, with a target price of $1.60, up from its last close of $1.2 a share.
Forsyth Barr senior analyst Chelsea Leadbetter said the bladder cancer test market opportunity was extensive and Pacific Edge was well positioned to capitalise on it.
“There is no shortcut to changing clinical practice and the hard work is far from over, however, recent key milestones have helped to prove up the commercial model and lower the risk.”
https://www.nbr.co.nz/story/pacific-edge-ceo-plans-retirement-following-strong-run

Brokerage companies like Forsyth bar has also given Plexure and outperform of $1.58.. they have absolutely no clue. I'd love to see how they come up with these figures given they are both growth companies and impossible to predict new acquisitions, contracts, revenue. These types of companies could change on a dime. So far plexure has ipo'd on the asx and not brought in another customer or another announcement since.
Forsyth/Morningstar = rubbish.

[calledone]

Brokerage companies like Forsyth bar has also given Plexure and outperform of $1.58.. they have absolutely no clue. I'd love to see how they come up with these figures given they are both growth companies and impossible to predict new acquisitions, contracts, revenue. These types of companies could change on a dime. So far plexure has ipo'd on the asx and not brought in another customer or another announcement since.
Forsyth/Morningstar = rubbish.

I believe they used a 10 year discounted cash flow method to come to that figure. It’s not out of thin air. Of course it’s all based on an ideal growth trajectory with more and more physicians becoming confident in the efficiency and accuracy of PEBs test suits.

I think a key difference between Plexure and PEB is that it’s much harder for potential competitors to catch up to PEB whereas it might be relatively easier for Plexure’s competition to replicate or augment existing tech to create a better version to engage new mobile users.

[glenscape]

agree with you calledone. PEB has some 10yrs advantage tech comparing with other players in this field. harder to be copied oppositing to PX1.

[Brain]

Another key difference between PEB and Plexure is that we know that PEB will be selling tests for $1000 NZ for a laboratory cost of $100 whereas we have no idea whatsoever about Plexures margin.

Disclosure hold both but heavily weighted towards PEB

[Greekwatchdog]

Investor update http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/370884/344438.pdf

[850man]

Investor update http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/370884/344438.pdf

especially pleasing to see in there "Since we achieved LCD coverage for CXBladder Detect and CXbladder Monitor from 1 July 2020 we have received close to 100% payment for CMS patient claims, within 35 to 40 days"

[calledone]

Investor update http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/370884/344438.pdf

Nothing new in this that we didn’t know. Was hoping to see some numbers but I suppose they don’t give that out in newsletter.

[Leftfield]

especially pleasing to see in there "Since we achieved LCD coverage for CXBladder Detect and CXbladder Monitor from 1 July 2020 we have received close to 100% payment for CMS patient claims, within 35 to 40 days"

No surprise in the above quote, however, It is the following para that we should be a tab concerned about....

"Negotiations continue with the CMS for the reimbursement of previously invoiced but unpaid CX Bladder tests done for CMS patients up to 30 June 2020......there is no certainty whether these tests will be reimbursed... or at what price."

Having previously been told that many millions $$ were likely to be able to be claimed back via this process, PEB now seems to be preparing us for disappointment.

[pierre]

Nothing new in this that we didn’t know. Was hoping to see some numbers but I suppose they don’t give that out in newsletter.

Of course not. We will have to wait for the EOFY report for that info - it's only a month away.

I have to say though I was a little disappointed when I read in the newsletter that they have adopted "PIHSS" as the acronym for their Patient In-Home Sampling System. I think a four letter version without the "H" would have been really appropriate and possibly attracted more market attention. Just saying. :scared: (Can't find a "tongue-in-cheek" emoji.)

Anyway, things still appear to be tracking OK, if a little slower than might otherwise have been the case without Covid.

Onwards and upwards and looking forward to broker SP targets of around $1.60 being achieved by year-end.

[BigBob]

Having previously been told that many millions $$ were likely to be able to be claimed back via this process, PEB now seems to be preparing us for disappointment.


There is no change in their messaging from last year... This is from the HY announcement from November...:

"There is no certainty of any reimbursement on any of these tests performed prior to 30 June 2020, and there is no ability to reliably estimate the level of consideration that would be received if agreement can be reached with Novitas Solutions Inc over these previously performed tests."

[psychic]

Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.

The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:

Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.

Guidelines current March 2021
https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.

Deal with Kaiser June 2020

PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP

July 2020 LCD by CMS

Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38388&ver=13

The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bladder-cancer-non-muscle-invasive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.

April 2021 United Healthcare covers Cxbladder

Well, they don’t, really. More exaggeration.

United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency

[Leftfield]

There is no change in their messaging from last year... This is from the HY announcement from November...:

"There is no certainty of any reimbursement on any of these tests performed prior to 30 June 2020, and there is no ability to reliably estimate the level of consideration that would be received if agreement can be reached with Novitas Solutions Inc over these previously performed tests."

Thanks BP - I was clearly being too optimistic.

[850man]

Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.

The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:

Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.

Guidelines current March 2021
https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.

Deal with Kaiser June 2020

PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP

July 2020 LCD by CMS

Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38388&ver=13

The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bladder-cancer-non-muscle-invasive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.

April 2021 United Healthcare covers Cxbladder

Well, they don’t, really. More exaggeration.

United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency

Great update Psychic - those inconsistencies are significant, suggesting this latest investor update from PEB was misleading. Am I over reacting?

[Minerbarejet]

It wont matter what level the revenue for the FY will be as Psychic will be disappointed anyway.

Might point out that obviously a considerable number of people in the medical/urology/physician/Urologist/CMS/Kaiser fields have no qualms about using CXbladder regardless of what AUA/NCCN/Psychic might think.

And if you cant get the poor sods in the door because of covid restrictions who is going to be doing cystoscopies anyway.

This PIHSS looks like it is well suited to this Covid scenario which shows very little signs of abating in the Fauci able future.

Also think that there might be quite a considerable backlog of recurrence testing building up if strict rules regarding cystocopies plus OMG cytology are left in place as suggested.

cxBladder has always been touted as an adjunct to cystoscopy in order to give better outcomes than cytology and all the other tests available.

[Balance]

It wont matter what level the revenue for the FY will be as Psychic will be disappointed anyway.

Might point out that obviously a considerable number of people in the medical/urology/physician/Urologist/CMS/Kaiser fields have no qualms about using CXbladder regardless of what AUA/NCCN/Psychic might think.

And if you cant get the poor sods in the door because of covid restrictions who is going to be doing cystoscopies anyway.

This PIHSS looks like it is well suited to this Covid scenario which shows very little signs of abating in the Fauci able future.

Also think that there might be quite a considerable backlog of recurrence testing building up if strict rules regarding cystocopies plus OMG cytology are left in place as suggested.

Psychic provides a valuable check against unwarranted exuberance and for that, I am appreciative.

Am looking forward to results in May for evidence of traction with LCD coverage & KP.

[Minerbarejet]

Psychic provides a valuable check against unwarranted exuberance and for that, I am appreciative.

Am looking forward to results in May for evidence of traction with LCD coverage & KP.

At what level will the evidence kick in?
Anything better than last year?
Half as much again?
Shock horreur, Double!!

[Brain]

It wont matter what level the revenue for the FY will be as Psychic will be disappointed anyway.

Might point out that obviously a considerable number of people in the medical/urology/physician/Urologist/CMS/Kaiser fields have no qualms about using CXbladder regardless of what AUA/NCCN/Psychic might think.

And if you cant get the poor sods in the door because of covid restrictions who is going to be doing cystoscopies anyway.

This PIHSS looks like it is well suited to this Covid scenario which shows very little signs of abating in the Fauci able future.

Also think that there might be quite a considerable backlog of recurrence testing building up if strict rules regarding cystocopies plus OMG cytology are left in place as suggested.

cxBladder has always been touted as an adjunct to cystoscopy in order to give better outcomes than cytology and all the other tests available.

Even without COVID, in home testing would be preferable for most - very convenient and no time or travel cost for city dwellers or country folk.

I am sure most people would like to take the PIHSS.

[pierre]

I am sure most people would like to take the PIHSS.

I think some ST members do that much of the time.:D

[Minerbarejet]

I think some ST members do that much of the time.:D
As a means of defense:)

[davflaws]

As a means of defense:)

I don't think CX Bladder gives reliable results if you PHISS against defence!

[jonu]

I don't think CX Bladder gives reliable results if you PHISS against defence!

Yes, much better against de lemon tree.

[davflaws]

Yes, much better against de lemon tree.
The last time the World Cup was held here I went home after the Japan Tonga game and watered the lemon tree. Very dark. Thought nothing of it since I had been eating beetroot.
Later that night I couldn't pee, went to the ED and was catheterised and scanned. It hurt but provided relief. TURBT the next day anbd about 15 cystoscopies and a couple of repeat TURBTs later I am all clear. I BELIEVE in CX Bladder!

[psychic]

The last time the World Cup was held here I went home after the Japan Tonga game and watered the lemon tree. Very dark. Thought nothing of it since I had been eating beetroot.
Later that night I couldn't pee, went to the ED and was catheterised and scanned. It hurt but provided relief. TURBT the next day anbd about 15 cystoscopies and a couple of repeat TURBTs later I am all clear. I BELIEVE in CX Bladder!

Scary stuff Dav, thank you for posting. We need to read more posts like this.

I think a lot here want to believe, but certainly without the experience you have been through. Great that you are clear!

Personally, I lost a fortune (well, a fortune relative to my standing anyway) believing in this Company and accepting what they had to say. Sadly, now I question everything. As much as I believe in the tests, the need, the science and opportunity, the good they will do, the Otago boys conquer the world thing, I see now that hype has been a necessary ingredient to funding and commercialization and to be blind to this and gushy over the prospects is just not a good investment stragegy.

So, if you don't mind sharing further, why do you believe in Cxbladder? You have gone through 15 cysto's, how many times was Cxbladder used in support or as an alternative and how much confidence was placed in the test result? Or do you mean you believe in the need for an alternative to what you have had to go through?

[psychic]

Miner, it currently turns over about the same $ as your local Service Station but without the profit. The Growth needed to justify the 3/4 billion dollar value placed on it by the market needs to be absolute hockey stick stuff. Real achievemnets need to happen for this growth to be likely, all you have so far is smoke and mirrors.

[davflaws]

So, if you don't mind sharing further, why do you believe in Cxbladder? You have gone through 15 cysto's, how many times was Cxbladder used in support or as an alternative and how much confidence was placed in the test result? Or do you mean you believe in the need for an alternative to what you have had to go through?

Thank you for your good wishes. Your story also helps me understand the tone of your posts.

My belief in CX Bladder at a base level rests on the science, and that is not the whole story because the test wasn't used in my case. The NDHB urologist who was in charge of my case doesn't believe it is cost effective (ie cystoscopy not much more expensive and part of the monitoring protocol anyway). I think he knows a lot more about urology than he does about cost accounting. I understand that my DHB has now introduced it as part of the clinical pathway anyway. Both the Registrars I have dealt with have shares in PEB.

But the strength of my belief is more about the fact that consumers are gaining power in their interactions with the medical system, and I doubt that there are more than a vey few males who would prefer a cystoscopy to a urine test. There will certainly be some initially, but I believe their first cystoscopy is likely to change their opinion. Even if my head didn't believe in CX Bladder, my urethra certainly would!

So we have a non invasive test that is backed by the science, that has a strong consumer preference, and that is actually cheaper than cystoscopy. What's not to like!

[Habits]

Crystoscopy procedure as per Google:
Your cystoscopy procedure might follow this process:

You'll be asked to empty your bladder. ...You may or may not need a sedative or anesthetic. ...Your doctor will insert the cystoscope. ...Your doctor will examine your urethra and bladder. ...Your bladder will be filled with a sterile solution. ...Tissue samples might be taken.

No thanks!

[Longhaul]

Miner, it currently turns over about the same $ as your local Service Station but without the profit. The Growth needed to justify the 3/4 billion dollar value placed on it by the market needs to be absolute hockey stick stuff. Real achievemnets need to happen for this growth to be likely, all you have so far is smoke and mirrors.

To help put the value into perspective for me, I just imagine what the market cap of Pacific Edge would be if it was a US company. I suspect it would be north of US$600M.

[psychic]

Great post thanks Davflaws, I am totally with you about cysto's. And that is an important point you make about consumers gaining more voice.

But unfortunately, we are a long way away from going without cystoscopies altogether as I understand it. Depending on each situation the Cxbladder suite of tests are being used as an adjunct to cystoscopy instead of cytology, to sort those that warrant cystoscopic exam and those that don't (Triage/ scan in NZ) and again, when the situation allows, as an alternative to cystoscopy when monitoring bladder cancer as an intermediate test to reduce the frequency of exams.

It is that understanding of just when and where each test is a suitable option (for now) and the range within the clinical pathway that becomes the issue for investors, particularly for those of us who are not Urologists.

[RupertBear]

Scary stuff Dav, thank you for posting. We need to read more posts like this.

I think a lot here want to believe, but certainly without the experience you have been through. Great that you are clear!

Personally, I lost a fortune (well, a fortune relative to my standing anyway) believing in this Company and accepting what they had to say. Sadly, now I question everything. As much as I believe in the tests, the need, the science and opportunity, the good they will do, the Otago boys conquer the world thing, I see now that hype has been a necessary ingredient to funding and commercialization and to be blind to this and gushy over the prospects is just not a good investment stragegy.

So, if you don't mind sharing further, why do you believe in Cxbladder? You have gone through 15 cysto's, how many times was Cxbladder used in support or as an alternative and how much confidence was placed in the test result? Or do you mean you believe in the need for an alternative to what you have had to go through?

I hear what you are saying Psychic. I bought into the hype a few years ago and have sat on a paper loss for a number of years. Thankfully I did not loose a fortune and I am sorry to hear you did. So sadly I now question everything as well. While I acknowledge things may have changed and PEB will be a very good investment I still have lingering doubts based on my past experience. So much so I have reduced my holding in PEB to ease my mind. I may reinvest once I have more confidence in how they are actually doing

[blu3]

For also having experienced a single cystoscopy in order to remove a ureteral stent while being fully awake, I'd also do anything to avoid experiencing this ever again.

I had this procedure done 8 years ago but you bet that my screams are still echoing in that hospital—I'm still traumatized to this day.

Go PEB!

[Maxtrade]

Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.

The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:

Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.

Guidelines current March 2021
https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.

Deal with Kaiser June 2020

PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP

July 2020 LCD by CMS

Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38388&ver=13

The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bladder-cancer-non-muscle-invasive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.

April 2021 United Healthcare covers Cxbladder

Well, they don’t, really. More exaggeration.

United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency


Does anyone know when we will be likely to receive further news that might provide further reassurance and support to PEB's progress and in turn fuel the next push higher in SP? Looking to put dates in calendar to check up on. Thank you

[Brain]

For also having experienced a single cystoscopy in order to remove a ureteral stent while being fully awake, I'd also do anything to avoid experiencing this ever again.

I had this procedure done 8 years ago but you bet that my screams are still echoing in that hospital—I'm still traumatized to this day.

Go PEB!

That is a very graphic description and why PEB should go well. I hope your howls of delight when PEB’s share price increases will go some way to lessening that trauma.

[jridler]

Does anyone know when we will be likely to receive further news that might provide further reassurance and support to PEB's progress and in turn fuel the next push higher in SP? Looking to put dates in calendar to check up on. Thank you
The rubber hits the road end of May.

https://www.pacificedgedx.com/investors/key-dates/