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Investor2014

06/21/21 5:30 PM

#316397 RE: Steady_T #316396

Anavex might get away with that.

I just have a fear the FDA won’t agree as they didn’t for another rare disease drug from Orphazyme, as I posted the other day.

Theirs was an actual P3 study with an fda suggested post hoc analysis exclusion of 3 patients with double gene mutation giving excellent stat sig results with a small n similar to the Anavex Rett P2 studies.
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Gernee20

06/21/21 11:52 PM

#316500 RE: Steady_T #316396

Really appreciate this post Steady. I think most of the board understood AA was based on a surrogate endpoint.

Could AVXL submit for AA based on the US rett trial and turn Avatar to our phase4?