Replies to post #33187 on Revive Therapeutics Ltd (RVVTF)

[Ecomike]

That post should be stickied folks.

Eco...

[rickstereo3333]

Mf should replace the current pr author with dales since he clearly does a much better job of presenting info.

[PennyWorld]

A long and winding road for RVVTF with the FDA. This is beginning to behave like the last 2 years of RLFTF. I predict that this study and subsequent potential FDA drug approval will run deep into 2024. The only hope is if RVVTF can convince the FDA to agree with new and different trial target goals. Dealing with the FDA is a time consuming mess, unless you are Big Pharma with resources and political clout. JMHO

[rickstereo3333]

the FDA determined that Revive’s proposed amended endpoint protocol, while still under review, does not support the time to resolution via the polymerase chain reaction (PCR) test.

When I first read this in the pr my understanding was that the trial data presented to the fda was not significant enough to justify revives, time to resolution, endpoint change request.

After reading dales report it seems thats not the case but rather that the submission by revives team was flawed because they relied on the now diminished method of pcr testing as core to their request.

Is this your impression also or did i misunderstand the article???