Replies to post #455243 on Anavex Life Sciences Corp (AVXL)

[hnbadger1]

Trulieve 2:05 from ST-
•$AVXL fda.gov/media/110903/ download has anyone seen this updated guidance from the FDA? It seems that this is HUGE NEWS! See lines 145-210 but what it looks like is that you only need one endpoint met to be cleared for approval now. For US ADAS COG does it. Didn't we do great with this endpoint? I hope we are going hard for approval right now and not waiting for EMA. How come this is not out in the mainstream?
https://www.fda.gov/media/110903/download

MayoMobile 2:11 PM
@Trulieve EMA realized that in very early patients (FDA defined as stage 1 through 3; Anavex of which enrolled primarily stage 2 and early 3) it is very difficult to assess activity of daily living improvement - because most of these patients don't have problems with ADL.
Now all you need is a strong cognitive endpoint (ADAS-COG), global endpoint for stage 3 patients (CDR-SB), and effect on underlying physiology (amyloid, tau, brain atrophy, etc).
Anavex likely to be granted
Accelerated Approval under this guidance.
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MayoMobile 2:11 PM
@Trulieve FDA****

[Steady_T]

That is not a final document. All in all it doesn't change much. It does mention surrogate endpoints but only lists amyloid plaque as an accepted endpoint.
The document suggests that other surrogate endpoints and biomarkers may be useful without saying what those might be.