Anavex Life Sciences Corp (AVXL)

[Anshu2]

On initial thought, ORs as an intermediate end-point for AA is plausible. But here are the issues with that:

1. AA would have to be broad label, since the trail was. It’s very difficult for me to imagine that FDA would restrict the label to responders — almost impossible, for various reasons.

2. Given #1, for FDA to give AA based on ORs, the n would really have to be significant (at least 30%, I’d say).

3. Also, Given #1, the confirmatory trial would have to be broad label too — with delta-Cog and/or delta-ADL as the final endpoints.

So, AA based on ORs as intermediate end-point is plausible but unlikely.