Anavex Life Sciences Corp (AVXL)

[kevindenver]

the FDA always prefers co-primary endpoints unless there is a bio-marker

The Anavex Rett is a P2/3 trial and was written more like a P2 than a P3 in that the "outcome measures" are as such, RSBQ is primary and within a long list of extremely important secondary outcome measures is CGI-I.

First your comment is pure speculation and second, I believe the anchoring concept is up for debate and has been the subject of academic discussion.

The single RSBQ endpoint anchored on CGI-I is not going to be accepted by the FDA as p3.

It is unfortunate biomarker development for a rare diseases aren't really a priority, it could have made the Rett trial design less subject to trial design arguements.

Also, within the secondary list are measures that may become biomarkers .