Replies to post #288813 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

A prespecified objective surrogate endpoint could be very good for the next trial yes.

Changing endpoints for an ongoing trial or even after is unlikely to lead to approval, but has been tried more than once.
When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?

[boi568]

Just exploring the possibilities. We should know that this is a Rett slam dunk, statistically, and very possibly elsewhere. May require unusual FDA cooperation. Then you get to an accepted biomarker, like lower cholesterol, and a quicker series of approvals down the road.

[XenaLives]

Nope, not for Aussie PA. Anavex only needs to present convincing science...

I believe this needs to be a preapproved surrogate endpoint prior to trial start.