Anavex Life Sciences Corp (AVXL)

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There is no EMA "rigid regulatory requirement" that rules out Anavex's 2b/3 trial for size and duration, and no EMA requirement, either, for ADL to be used as a primary endpoint in an early AD trial.

100% on that, which goes a long way toward understanding the acceptance of AVXL's MAA in Europe. If those requirements existed, it would make no sense for AVXL's MAA to have been accepted for review. The window is more hazy on the FDA side but, as we know, that situation may be in flux and may well change before AVXL submits in that jurisdiction.