Anavex Life Sciences Corp (AVXL)

[Steady_T]

The FDA has said that it likes to see peer reviewed papers. Is it a requirement? No. It does represent another review process from a different set of eyeballs.

My guess is that Anavex has been working on 2 or 3 different drug applications of late.

It seems likely that they were working hard on the Rett NDA with the expectation that the trail results would allow for immediate NDA application.
They also have been working on the MAA with the EMA as we have seen with the recent authorization to proceed on AD.
Now that the Rett process is up in the air I would suspect that Anavex is also working on the AD NDA for presentation to the FDA.

There is some commonality between the EMA MAA and the FDA NDA for AD and there are a lot of differences. The EMA requires drug labels and literature in 24 different languages for example although that is not due until 215 days into the CHMP review process.