Replies to post #502079 on Anavex Life Sciences Corp (AVXL)

[boi568]

The existing (not draft) EMA guidance requires FDA reviewers to apply the ADL endpoint in AD trials. In order for this not to occur, the FDA would have to find a good reason to make an exception. You are arguing as if the presence of a relevant guidance has no meaning.

I am conceding on your overall argument -- in other words, in your favor -- that I no longer trust the FDA today to honor their policies, so that an existing guidance may well, against all good administrative practices, simply be ignored. That would be a bad thing overall for the public, but a good thing in this instance for AVXL stockholders (and the public, given the merits of the draft guidance). Why follow rules and guidances if you don't want to -- or even the laws and the Constitution if they are inconvenient?

[La Flaca]

The most recently approved drug for ALZ, Lecanemab, was approved based on meeting the CDR-SB primary endpoint and plasma and amyloid-beta biomarkers. Blarcamesine's clinical trial measured ADAS Cog and ADCS-ADL as primary endpoints and CDR-SB as secondary, plus brain atrophy, Tau, and amyloid-beta. All stat. significant, but the ADCS-ADL achieved it outside of the 48 week period. Nonetheless, there's never been a better performing drug that has filed for approval with EMA.