Replies to post #488906 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

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.

[sab63090]

boi568

Wow, wow, wow! I didn't know that.......😍

[Investor2014]

Nor is there from the FDA or other regulators.

There is no EMA "rigid regulatory requirement" that rules out Anavex's 2b/3 trial for size and duration

Writing a list of all the things that a regulator would not normally accept is one of those misguided WGT ideas.

I guess one use for such a scheme could be to keep lawyers and regulation writers very busy.

Its a bit like the story of the women who decided to dry her rain soaked cat in the microwave oven. Then sued the manufacture for not clearly stating in the manual not to dry cats with their microwave oven.

Look at the likes for such nonsense in a post - very telling.

Try to be biotech investors.