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Steady_T

11/04/24 1:21 AM

#473069 RE: crescentmotor #473068

It seems to me that the FDA NDA filing will occur before the EMA renders a decision. My guess is Anavex will wait until the MAA is accepted and past the first stop clock so it will have an understanding of what the regulators want that is not in the original filing. With that knowledge in hand Anavex can craft the NDA and expect it to be processed more smoothly.

I hope that Anavex applies for Priority Review when they file their NDA. That could set the stage for both regulators decisions about the same time.