Interesting info thank you for sharing.
I read a while ago that the FDA was unhappy with Novitas decision to say who and what they pay for as its was the FDA'a decision to make. Novitas just pay the bills..
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Interesting info thank you for sharing.
I read a while ago that the FDA was unhappy with Novitas decision to say who and what they pay for as its was the FDA'a decision to make. Novitas just pay the bills..
Seems that PEB need to completar evisculate extensible services and it will be a game changer
It's a Creative Commons and can be shared so long as it's cited and not altered. The last paragraph is pretty clear:
"In conclusion, in this prospective multicenter randomized controlled trial, use of CxbT to inform the decision for cystoscopy in patients with LR hematuria resulted in a 59% reduction in cystoscopy. This demonstrated clinical utility of CxbT to safely reduce the burden of unnecessary cystoscopies in this population, theoretically resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact."
I think this is good news and hopefully it will have some sway on the Novitas decision. However, it appears to show results regarding clinical utility when the original concern for Novitas was the perceived bias in PEB's early clinical trials for efficacy. I'm certainly no expert, but are the results of the STRATA study enough for Novitas to put aside those original concerns? It would be great if that was the case, but who would know. Even if it is enough for Novitas to change their minds, I don't think that will happen before the July deadline. Given what we know of how slowly things work in the USA health system, a positive outcome based on the STRATA study may still be some time away.
My understanding is that efficacy is the ability to produce a desired result. The PEB result confirms that PEB's CxBladder can produce the desired result of safely identifying issues without the need for invasive surgery. The whole idea of doing a randomized control trial is to remove selection bias. I'm not sure whether the result is a king hit to secure Medicare
(as it was completed by PEB and not a independent research company), however it is peer reviewed and if it is supported by the urology community (I don't have access to the full research or info on this), I would be surprised if Novitas does not at least delay this current attempt to remove coverage, and give PEB another e.g. 12 months to get more research completed.
DYOR - Disc - holding
PEB looking to kick on from last week. Where's it all end? :D
I am somewhat surprised by the market being underwhelmed about the STRATA study endorsement on CX Bladder and the presentation to the American Urologist conference. To date SP up 4.8% this morning, but this stock has always news driven. I know patience is a virtue but this stock was first listed in 2003:(
It is likely that none of the big broker firms will look at PEB until PEB releases further information on 21 May 2024. We will get bigger positive movements after 21 May 2024 or if Novitas confirm Medicare coverage.
So a negative result requires no Cystoscopy and a positive result does??????