Replies to post #417162 on Anavex Life Sciences Corp (AVXL)

[Anshu2]

I had explained this earlier.

If AVXL gets AA based on some biomarker data in P2b/P3:

First assumption is that FDA will only give AA without any subgroup analysis, except for the dosage grouping. This assumption is extremely likely to be true.

With that assumption — a confirmation trial would need to show clinical benefit for the same population as in the P2b/P3 (else it wouldn’t be confirming the basis of AA).

That’s why.