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Re: F1ash post# 169031

Saturday, 10/20/2018 5:27:52 PM

Saturday, October 20, 2018 5:27:52 PM

Post# of 518981
“ This study will be followed by a planned placebo-controlled safety and efficacy evaluation of ANAVEX®2-73 over a 3 month treatment period. “

Seems to me that the 3 month study will be a different study and not connected with it.

M with request for protocol for above study which he had talked about but FDA requested kind of safety by conducting shorter study.

IMO it is same as Phase 1, then evaluation of data, new design of next trial and submission of separate protocol.

Well 1 year is lost and one trial is added - 6-8 months also added to timeline. Right approach by fda and shows that the quick final results/approval of Rett that was expected is not on the cards.
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