PEB-Pacific Edge

[Habitz]

Darkest before dawn...? Certainly looking dark while awaiting acceptance

[LoungeLizard]

Darkest before dawn...? Certainly looking dark while awaiting acceptance

We've had years off famine but there could be a veritable feast for investors if Novitas change their minds and the AUA include CXBladdder in the new guidelines. All speculation of course, but I'm fairly confident that at least one of those things will come to pass, which would be a game-changer in itself.

[Crackity]

We've had years off famine but there could be a veritable feast for investors if Novitas change their minds and the AUA include CXBladdder in the new guidelines. All speculation of course, but I'm fairly confident that at least one of those things will come to pass, which would be a game-changer in itself.

Pick your best definition eh - I like that


to be far advanced, ahead, well gone, long gone, distant - usually followed by atu or mai. Ka oti te takutaku ka tukua te teka kia rere, kātahi ka ...

[SuperMario]

We've had years off famine but there could be a veritable feast for investors if Novitas change their minds and the AUA include CXBladdder in the new guidelines. All speculation of course, but I'm fairly confident that at least one of those things will come to pass, which would be a game-changer in itself.

Are there any expected timeframes on these?

[Greekwatchdog]

Are there any expected timeframes on these?

No there is not. Novitas are currently on extension, so answer could come anytime.

[Greekwatchdog]

December update ex Facebook. Link below
https://www.cxbladder.com/assets/New...n-Dec-2024.pdf

[Shareguy]

Bad news as expected.

" As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and are therefore, are not payable.'

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39365&ver=131&stateRegion=all&contractorNumber=all&proposedStatus=F&sortBy=noticeStart&bc=11

[Shareguy]

No announcement on NZX. Maybe they don't know yet or still on holiday.

[Greekwatchdog]

No announcement on NZX. Maybe they don't know yet or still on holiday.

I imagine we will get a trading halt until they sort their interpretation of what this means out.

[winner (n)]

Just another hiccup on the long road to success

No worries, just be patient

[Left Field]

Trading halt..... CMS results not looking good for holders as per Shareguys post #396 above.

https://api.nzx.com/public/announcement/444922/attachment/435451/444922-435451.pdf

[Shareguy]

Had a look at Craig's latest note from 27/11

prior sections we outline our conservative expectation that PE coverage in FY26 but regain it in FY28. This will effect:
Test volumes: We think Medicare coverage loss will reduce non-Kaise 80% from 11k in FY25 to only 2k in FY25. This is because only 40% o volumes are not paid for by Medicare, and we assume 50% of these ch cuts and constraints on which customers PEB can sell to. We expect r remain flat at 2k up to FY28 when a resumption of coverage allows a r growth commensurate with when volumes were last at a similar le growth reducing slightly over time as non-Kaiser volumes return to FY of coverage will set non-Kaiser volumes back 6 years.
We expect a ramp in Kaiser volumes will offset some of this decline, pr cash flow over the period (which importantly does not require signific think Kaiser volumes will ramp from 26% of volumes presently to 68% ir
Costs: Post coverage loss, we think PEB will slash S&M costs 70% and levels) by the end of FY26. We think R&D will remain flat for the expenses will remain at this muted level until FY28 when coverag expenses will return to levels commensurate with what they were whe a similar level.
By these numbers, PEB will need to raise $35m in equity

[LoungeLizard]

Trading halt..... CMS results not looking good for holders as per Shareguys post #396 above.

https://api.nzx.com/public/announcement/444922/attachment/435451/444922-435451.pdf

"The determination covers significant new information and Pacific Edge needs time to assess the
implications of the announcement, consult with US legal advisers and industry partners, and prepare
an announcement that provides context to investors."

That doesn't sound too promising, unfortunately. It is hard to see how Novitas could remove coverage and on what grounds, given the industry support and successful trials, but that seems to be what is being implied, hence the involvement of legal advisors. It will be blow to PEB's prospects if coverage is removed, but probably not fatal as per Craig's analysis. The wait goes on. Sigh.

[LoungeLizard]

Arggh - it does indeed sound as though coverage will be removed:

"In conclusion, the Cxbladder line of tests all suffer from insufficient test validation, a foundational problem in which potentially confounding clinical circumstances include non-TCC neoplasms and malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including a foundational study from Holyoake in 2008 that only used Japanese patients from one location.28 Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers, particularly when there are issues not discussed in Pacific Edge Diagnostic funded papers that are subsequently addressed by non-funded studies, such as the 2019 Davidson study which identified increased false positives in patients with non-TCC malignancies.41 As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and are therefore, are not payable.'

Wonder what the hit to the SP is going to be???

[BlackPeter]

Amazing - not really following this stock, but just noticed - its now 20 years that PEB was good for generating hype without end - and punters always hoping that this next move creates the break through. TWENTY years and some amazing decks! Did I miss the party?

You cannot view this attachment.

Interesting SP movement - apart from two lonely peaks (great for traders in the know) nothing happened - but hey, plenty of traders make money as well from the jitter, and clearly - the investors and believers did pay.

No doubt, though - this time it will be different, and hey - if its a (hype-) cyclical, then the next peak might be in 2028/29 ... but - don't take my word for it ;