Replies to post #430660 on Anavex Life Sciences Corp (AVXL)

[dennisdave]

I have the same question, but given the reasonable assumption that Anavex does not have an agree upon SAP with FDA for AD, it might give Anavex an opportunity to negotiate one through discussion with FDA or a foreign authority which is disclosed in today’s PR:

FDA rules dictate that its not impossible to have the FDA buy-in on new SAP/endpoints post hoc data collection, and data scrubbing after data lock but it is highly unlikely. Especially if the new endpoints are unusual/controversial to the FDA as you pointed out.

I'm betting on 5% AA and 95% on a P3 ADD trial. Having said that I think Anavex should count its lucky stars if they get the endpoints and SAP bought in by the FDA as presented in yesterday's (summarized) PR. IMHO