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Gernee20

09/15/17 8:37 PM

#120411 RE: Investor2014 #120372

If the FDA is allowing multiple trials to start, with the idea that 2-73 can treat multiple indications, and somehow streamline approval, with direction and guidance from the FDA, as many have pointed out, it's possible all trials need to be designed before we see a start of Anavex trials. This seems absolutely a reasonable cause for delay in Rett start. It's possible Rett trial was ready months ago, but until PK and AD trials are designed and aligned with endpoints and with the new Cures Act guidelines, which would streamline approval of 2-73 for all 3 diseases, no trials can start. Piggybacking off this point, it's possible the FDA wants all the trials to start within a couple months of each other?

Thinking out loud...