Anavex Life Sciences Corp (AVXL)

[Steady_T]

I don't know that AA is easier. Missling said that was the path that the last two AD drugs had successfully used so that is the path Anavex will use.

Go with the flow.

It appears to me that conventional approval would be a possibility if all endpoints have been met as the company has stated. That approach is vulnerable to the relatively small n for a P3 AD trial.

Looks like utilizing the biomarker / AA approach will sidestep the small n issue.
Consider this, the FDA is presented an AA NDA based on multiple biomarkers. Those all point to the drug working. In addition to that, conventional AD measures of cognition are also presented that show efficacy. Those measures would be acceptable evidence of efficacy by themselves.

The combined package would present a very strong case for approval.