I find that unlikely for the following reasons. The FDA will release the new protocols in Sept. It will take Missling and crew a bit of time to design a trial to match the new protocol. After submission the FDA has to review it and the staff has to figure out the new protocols and see if the proposed trial meets them. No bureaucracy moves fast in the face of new rules.
Even if recruiting is done while the FDA is in approval process I think we are talking November at the earliest.
I think it is more likely that the Rett trial will be done under the existing rules. It is a short trial. The endpoints should be easy to measure. The response to 2-73 is expected to be rapid. My guess (this is just a guess) is Anavex already has a good idea of the appropriate dosages. If they do want to try a few different dosages, the existing p2b trial adaptive structure might be smiled upon by the FDA.
Trial approval under the old rules should be fairly fast since this already an ODD designation.
So for those reasons my expectations is old rules, rapid approval, start of trial fairly soon. Some others have raised the issue of subject recruitment as being a problem. Given the lack of alternative treatments and the involvement of the Rett foundation, recruitment should not be an issue. Coordinating subject baseline evaluations might be an issue. I suspect that all of the potential subjects are already connected with medical care that can do what is required, but that is just a guess on my part.
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