PEB - Pacific Edge Ltd

[psychic]

Many thanks Miner and Hancocks.

Yes, something very dodgy with that certndx eh. The link to the biocentury article is now behind a paywall Miner, but I see Casino found it later (where's he gone anyways?) and it is well worth the read :

http://media.drugwonks.com/media/att...pdf?1374059870

I'm wondering if the certNdx test needed NMP22 and Cytology alongside to achieve it's results as it didn't seem to survive the scrutiny of the new CMS coding system?

Anyway. Here is some more light reading - Bluecross Policy on Urinary Tumor Markers , reviewed March 2014

https://www.bcbsal.org/providers/policies/final/433.pdf

It mentions both certndx and cxbladder as both being available commercially (but not approved by FDA or Bluecross); other tests that are not available yet; and details the tests that are used ( and approved) ie cytology, NMP22 etc.

Does it set the tone for the next review do you think? (I'm thinking cxbladders inclusion as as an adjuct to cystocopy and replacement of nmp22 and cytology)

It introduces cxbladder but is otherwise silent on it and seemingly does a good job of detailing the inadequacies of everything else...(Perhaps my enthusiasmm for cxbladder playing tricks)

cheers

[robbo24]

thanks for the info but once again I believe this further indicates the battle ahead cxbladder has.
For a start it looks like some insurance companies wont cover products that do not have FDA approval.
Secondly this comment there exists a dizzying number of markers identified using newer expertise
Whilst there is nothing wrong with a bit of competition one wonders how long it will be before cx bladder lose's it's advantage's both product wise and cost wise.
Can anyone explain to me why PEB have bought cx bladder to market prior to obtaining FDA approval. Seem's to me this could be a major issue.

Look up Laboratory Developed Tests. This has been discussed ad nauseum on this thread.

[Minerbarejet]

Thanks for the links - by the time I get to the end in about 2017 things should be all sorted.
Boy there is certainly some stuff in there.

[robbo24]

thanks for the info but once again I believe this further indicates the battle ahead cxbladder has.
For a start it looks like some insurance companies wont cover products that do not have FDA approval.
Secondly this comment there exists a dizzying number of markers identified using newer expertise
Whilst there is nothing wrong with a bit of competition one wonders how long it will be before cx bladder lose's it's advantage's both product wise and cost wise.
Can anyone explain to me why PEB have bought cx bladder to market prior to obtaining FDA approval. Seem's to me this could be a major issue.

Look up Laboratory Developed Tests. This has been discussed ad nauseum on this thread.

[MAC]

A contextual point of note also from both a marketing and clinician’s ‘pre-dissonance’ perspective;

It takes a big quantum leap in technology for a new product in this sector to become a prevalent norm. NPM22 was a big leap and was the norm for over ten years until RNA based test methods were developed, which of course do a lot more than NMP22 is capable of also.

Cxbladder thus far is the leader in the race to become the takeover technology, it’s ahead in patent filing, clinical performance, laboratory readiness, commercial roll out, and market entry.

Consolidation is the now the key. If achieved progressively over the next 12 months, any competitor would have to come up with an even greater leap in technology to achieve the markets consideration as the next norm.

A competitive product the same or similar is not enough, even if they had regulatory approvals and laboratories all good to go tomorrow, PEB would still be ahead in the marketing race to become the new norm.

[Minerbarejet]

There seems to be a general tone in this thread that its all or nothing for PEB ( not meaning anyone in particular). This is not entirely true. It seems PEB's plan is to capture 10 to 15 percent of the US market. Raises the question - who captures the other 85%? Certndx? Cytology? NPM-22. Seems to be plenty of room for everybody to have a bit until it all gets sorted as to which is best - it will take time but once those results start coming back then who knows what the cxbladder market share will be. The question is really whether cxbladder is good enough to get established. Clinical trials have proven that it is superior to anything currently available so it looks as if it should have its day in the sun.
You also have to remember that PEB still has that pipeline and may be working on an improved cxbladder already after all they got a fair old whack from Callaghan for R&D. Its ongoing and not just focussed on the immediate future for one product. I believe that the idea was for cxbladder to provide the revenue to expand the market into asia and bring new products forward as well.
Just a few thoughts for early Sunday morning of Revelation Week

[see weed]

At least you didn't call us a bunch of JAFA'S Moosie.

My JAFA family has lived here for 170 years, so we know all the short cuts to avoid all the outer towners who clog up the north and southern motorways and from the airport, all following each other not knowing where they are going. ps takes me an average of 5 minutes to a lot of my work places, and that includes a toilet stop on the way. lol

[percy]

My JAFA family has lived here for 170 years, so we know all the short cuts to avoid all the outer towners who clog up the north and southern motorways and from the airport, all following each other not knowing where they are going. ps takes me an average of 5 minutes to a lot of my work places, and that includes a toilet stop on the way. lol

Would you be so kind to share your knowledge with me.?
I would like to know what route you would take from the Airport to Poland Road, Wairau Valley? Or just from the airport to the bridge?

[MAC]

Now the lab rat’s three month macro event dip seems broken we seem to be left in a spot where the SP would absurdly seem to price in zero sales and significant backwards progress in Pacific Edge’s roll out. I suspect this won’t actually be the case come Friday.

> The share price at the last HY14 report (first US sales) was $1.46 (+32%)

> A min valuation for US Cxbladder sales only is around $1.70 (+42%)

> Pacific Edge is well off its February highs of $1.76 (+44%)

I would suggest that Pacific Edge may well report some quite positive commentary actually this coming week, some progress on the two new Cxbladder products due to be launched, the ramping up of the US laboratory and sales team, and perhaps some advice on how the twelve month HMO negotiations are progressing a few months into them now.

I’m looking for some commentary on Medicare now that US insurers are finally submitting their 2015 rates for Obamacare by the end of this month, previously March. It is possible that this becomes a point of focus for commercial negotiations between Pacific Edge, Medicare and HMO’s as the forward twelve month pricing contracts for Cxbladder probably ought need to be reasonably consistent within the market place.

I would not be surprised to see this report mark the timely start of some of the larger funds buying in now as they may well see profitability on the near horizon, perhaps with an NZ50 component requirement also.

The focus of the Pacific Edge up to the end of the reporting period to 31 March has been on hiring and training staff, and on initiating access to the HMO’s and kicking off the twelve month negotiation processes as were previously advised to us.

It’s interesting timing about now, and regardless of what concurrent or coincident sales may have been forthcoming up to 31 March, PEB is an absolute fundamental BUY at these levels.

[Snow Leopard]

...It’s interesting timing about now, and regardless of what concurrent or coincident sales may have been forthcoming up to 31 March, PEB is an absolute fundamental BUY at these levels.

We know you like it, but absolutely fundamentally it is currently a highly speculative share with a very uncertain future:

At one extreme there is the risk that they will never achieve sufficient sales in an adequate time frame to remain solvent.

There is also the risk that they may actually do very well, even better than you predict.

But, and I say it again in a slightly different way, currently this is a very speculative share with a very diverse range of possible futures.

DYOR

Best Wishes
Paper Tiger