Replies to post #430658 on Anavex Life Sciences Corp (AVXL)

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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:

All prespecified clinical endpoints were analyzed using a mixed model for repeated measures (MMRM). The MMRM analysis method is the convention used for regulatory filings and discussions with regulatory authorities are in preparation.

The evidence there is no FDA approved SAP are 1. The AD trial is registered as non FDA regulated drug on ct.gov 2. From 10Q, the company disclosed the endpoint changes are approved by EU and Australia government where the trials are taken place, not FDA.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No