Replies to post #473028 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

Our FDA delay is very likely to focus on the EMA, and then leverage that effort into the similar FDA submission.

My bet is that a prior EMA regulatory approval would have considerable weight in the FDA's deliberations surrounding Blarcamesine. For multiple obvious reasons that have been discussed, I believe AVXL's decision to approach the EMA first may prove to have been a great decision.

[Anshu2]

Company needs an OK from FDA to file. Likely, FDA has rebuffed them till now — maybe their mind will change with “new” data?