The interim data review by the DSMB was October 2021. Though patients remain individually blinded, Anavex would get group safety data, recruitment status, dropout number, etc. Anavex would have known that many patients dropped out during titration and may have made adjustments to the SAP at that time. I think that is likely. I think companies should publicly disclose their SAP along with key protocol changes but this is not required. Missling often seems confused about the concept of outcome measure vs. endpoint when he presents but regulatory agencies are not confused. Anavex did not have a special protocol assessment (SPA) so SAP adjustments would be submitted but not carefully evaluated as to whether the endpoint change would be acceptable for approval. Missling has left so many loose ends. Anavex looks to have a solid 2b, time to design the phase 3 and get it started. Hopefully they will have a strong enough belief in A273 to get an SPA with the FDA and/or related acronyms with other agencies.
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