I am hoping that in fact Anavex are not directly dependent on new FDA announcements. I suspect that the trials are designed and ready to go bar some final adjustments perhaps to inclusion/exclusion criteria based on KEM Analysis.
No doubt Cures Act, surrogate endpoints, possibly master protocol, RWE etc. will be beneficial to approval. But, I am yet to see any specific suggestions as to what is lacking for the trials in existing FDA guidance and protocols.
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