PEB - Pacific Edge Ltd

[mr optimistic]

Interesting update. 15% fall in tests but half the commercial team from 34 to 17. Gotta stop the bleeding. I actually like it.

[frogkiwi]

The way I see it there are two main points in this, first, does the test work and give you the information claimed. FDA say they should be assessing this and approving. Secondly, are your labs up the the standards. CMS should look after this side.
This has probably all been driven by the Novitas stance with the FDA now coming to the party effectively saying this shouldn't be funder driven, this should be clinically driven. We've dropped the ball, thanks for bringing it to our attention, here's how we going to approach this moving forward. This is probably a good thing as it maintains a certain standard and gives physicians some assurance of quality. Lets just hope for the PEB shareholders, PEB has already engaged in dialogue with the FDA and CMS. Once this is completed I would have thought Novitas would then fund any FDA approved test.

[winner69]

Interesting update. 15% fall in tests but half the commercial team from 34 to 17. Gotta stop the bleeding. I actually like it.

Downsizing in both respects

http://nzx-prod-s7fsd7f98s.s3-websit...093/411290.pdf

[850man]

I think PEB need to cross the FDA hurdle as top priority if they want to continue in the US market. They have done all they can with Novitas, that is now out of their hands. FDA have approved tests that are far less effective in terms of specificity, NPV and PPV so FDA approval of CXB is entirely possible. The potential future Novitas outcome is funding approval for FDA approved tests. I think this is highly likely.

[winner69]

I think I’m more confused than what PEB were

http://nzx-prod-s7fsd7f98s.s3-websit...100/411297.pdf

[frogkiwi]

I think PEB need to cross the FDA hurdle as top priority if they want to continue in the US market. They have done all they can with Novitas, that is now out of their hands. FDA have approved tests that are far less effective in terms of specificity, NPV and PPV so FDA approval of CXB is entirely possible. The potential future Novitas outcome is funding approval for FDA approved tests. I think this is highly likely.

I had a bit of spare time so went looking for the FDA proposal. As far as I can see, in the FDA proposal https://www.federalregister.gov/docu...eveloped-tests , the date by which they want to go live with the new process is 1 April 2028 (hopefully not an April fools joke). Looks like this is to provide companies time to understand requirements, submit everything they need etc etc.
This is a few years away and raises the question as to what happens with funding in the meantime and what approach will Novitas take while this is being sorted. In a ideal world Novitas would come out with a list of approved tests, CXB included, covered until this date, or they might just leave it all up in the air.
In my opinion after reading this, this isn't about dealing with legitimate tests (hopefully like CXB), rather it sounds like the lack of regulation has allowed a large number of less than sound labs to open and offer some perhaps less than scientifically sound tests with some questionable ethical behavior.

[psychic]

https://scholar.google.co.nz/scholar...&pos=0&folt=kw

AUA has just reviewed Guidelines for use of Urine Tumour Markers but sadly Cxbladder still not recommended. Hope in the future for Cxbladder Monitor perhaps on further evidence.

Not great....

[850man]

From an article today in UroToday "The authors also stated that the future directions of novel urinary biomarkers held promise, citing the CX Bladder platform as an example of how advances can be made in the sensitivity of detecting high-grade NMIBC" Article here http://www.urotoday.com/center-of-ex...er-cancer.html

[psychic]

Ai getting in on the act now.
https://scholar.google.co.nz/scholar...&pos=0&folt=kw
Small study but impressive results. Models led to 0.977 sensitivity, 0.972 specificity, and 0.973 accuracy values for the blood samples, and 0.987 sensitivity, 0.829 specificity, and 0.953 accuracy values for the urine (KCl) samples

[Roskat]

Sunday, February 4, 2024

Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment

HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
###
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here.
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
https://www.thefdalawblog.com/wp-con...-12-4-2023.pdf
Topics include:

• Prohibitive costs of the rule
• Poor presentation of LDT risks and no presentation of LDT benefits
• Deeply flawed economic analyses
  
  • Multiple categories of costs ignored and underestimated
  
  
• Existing regulatory framworks are ample
• FDA lacks statutory authority
  
  • Elaborate statutory discussion

The letter makes a point I have made, the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38). ##