PEB-Pacific Edge

[Left Field]

Just having a punt I feel ...hoping they get lucky ....

Takes one punter to know another aye Winnie. 

[Left Field]

BlackRock also taking a punt..... 5.8% holding.

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/416083/400070.pdf

[Left Field]

Bizarre, BlackRock announcements retracted.

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/NZXO/416144/400132.pdf

[LoungeLizard]

Not good enough from NZX - very confusing for investors. Are Blackrock buying in or not - and if they are investors are required to be informed. What is the nature of this "retraction"? Was the initial announcement incorrect in substance? Not very transparent - and NZX are partly to blame.

[LoungeLizard]

https://www.pacificedgedx.com/news-and-events/news/2023/us-urological-societies-call-for-medicare-lcd-revision/

[Left Field]

Impressive support for PEB bodes well.

The American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) - the three most influential urological organisations, covering every practicing urologist in the USA - joined with the Coalition for 21st Century Medicine (C21), the American Clinical Laboratory Association (ACLA), and Pacific Edge to call for significant revisions to the draft determinations and continued Medicare coverage of Cxbladder.

[Left Field]

On the leader board in early trading today.....

To read the LCD submissions from AUA etc (as per above post,)  follow this link. Impressive support for PEB from key organisations..

https://www.pacificedgedx.com/investors/presentations/

[LoungeLizard]

On the leader board in early trading today.....

To read the LCD submissions from AUA etc (as per above post,)  follow this link. Impressive support for PEB from key organisations..

https://www.pacificedgedx.com/investors/presentations/

Yes, industry support for CXBladder is very strong and it remains to be seen whether it will have any bearing on Novitas's eventually decision. If clinicians are positive (plus it saves money), then it's hard to see how Novitas can continue to maintain, independent of all the expert medical bodies, that there is no medical benefit. Will they change their minds, particularly if there is similar strong written submission support from industry is the big question.

[Left Field]

Yes, industry support for CXBladder is very strong and it remains to be seen whether it will have any bearing on Novitas's eventually decision. If clinicians are positive (plus it saves money), then it's hard to see how Novitas can continue to maintain, independent of all the expert medical bodies, that there is no medical benefit. Will they change their minds, particularly if there is similar strong written submission support from industry is the big question.

Pending Novitas's decision PEB remains a risky investment.

However, reading these submissions it is clear that Novitas's earlier decision contained huge errors and elements of predetermination. PEB won its first legal challenge of Novitas based on procedural issues. The predetermination element remains untested and could potentially be very costly for Novitas if their next determination is as bad as their first one.

In light of these legal issues Novitas will now have to tread very carefully and given the strong evidence now tabled showing the cost savings and other benefits of PEB's diagnostic tools, IMO the balance of a favourable outcome has swung in PEB's favour. Of course this is just one opinion, and is not intended as any advice. DYOR.

(This my last post for a few months as I take an extended break. Happy investing all.)

[Ferg]

Pending Novitas's decision PEB remains a risky investment.

This 100%.  All the eggs are in one basket and, looking at the company history and approval fiasco, I sense PEB is running on "Hopium".

Disclosure: never held, another morbid curiosity

[Left Field]

PEB  SP tops the leader board last week  (up about 26% for the week)  on the back of PEB releasing detailed submissions made on it's behalf to Novitas earlier.

https://www.pacificedgedx.com/investors/presentations/

Amongst the presentations, The American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) provide strong support for PEB's case, concluding;

".....we firmly believe the implications of the Draft LCD will detrimentally impact access to urine-based tumor markers in the context of bladder cancer, thereby compromising patient care. If urine-based tumor markers are to be included in an LCD, their coverage should be determined through appropriate use criteria widely recognized by the specialty of urology and guided by expert input and stakeholders. We implore you to reconsider the inclusion of these tests in the proposed LCD and stand ready to engage in further discussions about the merits of these tools in patient care."

They also detail cost savings achieved by using the PEB tests.....

"The cost of tumor marker testing is remarkably insignificant when considered in the context of the massive spend associated with the surveillance and treatment of bladder cancer patients. An average FISH (ie PEB) test costs less than 1% of the $55,267 median attributed cost after two years of bladder cancer treatment. A study published in the Journal of the American Medical Association Network (2020) underscored total median costs at 1 year were $29 459; at 2 years, $55 267 and at 5 years, $117 361. Patients with progressive disease had significantly higher median 5-year costs ($232 729 vs $94 879), with outpatient care, pharmacy, and surgery- related costs contributing.xi A FISH (ie PEB)  test costs approximately $500."

Reading through all the submissions it seems that opposition to the proposal by Novitas has galvanised impressive stakeholder support that bodes well for PEB in the future.

[LoungeLizard]

PEB still running hot - Up 12% today on high volume. Does Mr. Market know something or pure speculation? Most probably the latter, but it does seem that the odds are shortening on a favourable Novitas decision.

[Hectorplains]

PEB still running hot - Up 12% today on high volume. Does Mr. Market know something or pure speculation? Most probably the latter, but it does seem that the odds are shortening on a favourable Novitas decision.

Yeah, and on huge volume (for PEB) too.  31m is about 4% of their register. That's nearly twice their next biggest trading day in the last two years.  Bit of an eyebrow raiser, eh.

[bulltrap]

Replying to 850man's message on 'the other site' here, since I've lost the ability to post there. Hope he/she/they are viewing here too.

Yes, CXBladder is seen by urologists as a key part of the diagnosis of haematuria, based on the AUA feedback to Novitas' proposed LCD. http://nzx-prod-s7fsd7f98s.s3-websit...969/402704.pdf

I have a friend, let's call him beartrap, who recently underwent screening for microscopic haematuria at a respected hospital in Southeast Asia. When it came to ruling out bladder cancer, it was cystoscopy or nothing. The urologist claimed he hadn't even heard of Cxbladder.

The cost of the two are similar, and for the doctors nothing beats getting in there and having a poke around.

(disc: just an avid spectator)

[Basil]

Same for this dog at North Shore hospital many years ago.  The urologist had heard of CX Bladder but said you simply cannot beat the gold standard of a cystoscopy and having a good look in there.  Wasn't my most fun day in recent years by any means but I'd rather have the gold standard by a urologist with decades of experience than be a lab rat for PEB's hit and miss test.  Beagle's have a very special dislike for posing as a lab rat.