Anavex Life Sciences Corp (AVXL)

[crescentmotor]

I find it hard to believe that the company has not had meaningful conversations with them [FDA].

I don't believe for one second that there have been no exchanges/communications between AVXL and the FDA. After all, that certainly has occurred between AVXL and the regulator in Europe. Note that there is not even a single sentence in 02/07/2024 that mentions seeking approval in AD for 2-73 in the U.S.

Or are they really just waiting for the peer review then go to the FDA? I find that hard to believe as well.

A peer review is not necessary before seeking FDA regulatory approval. Waiting on a peer review gave Missling the many additional months he needed to continue data mining in order to try to fortify the trial results as well as explore the possibilities for regulatory approval across the pond. If the 2b/III could stand on its own in the U.S., a NDA could have easily been filed by the end of 2023. Missling has been stringing this along since December 2022. It failed the smell test long ago just like the extended delay in releasing the Rett EXCELLENCE data. The big question is will the 2b/III data be viable enough for commercial approval in Europe? Missling's credibility has been stretched past the breaking point.