Anavex Life Sciences Corp (AVXL)

[Hosai]

IMO I'm guessing Anavex most likely recieved mixed/ambiguous feedback in regards to applying to FDA in 2023, especially in regards to ADL end point. Missling was perhaps going to wait for OLE data and/or the peer review (perhaps even hoping for the peer review to in part make the case that ADL was difficult to show in early AD trials).
Now with the change in FDA draft guidance if all this was the case that it seems things have obviously changed. Perhaps companies might still want to wait for the guidance to become official? Either way it would seem AVXL could apply to FDA anytime...they said they went with EMA first because that process takes the longest and the EMA pr's came out of nowhere last time so there may not be much warning beforehand.