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Steady_T

08/07/17 1:32 PM

#114295 RE: Amatuer17 #114293

- have they submitted IND for Rett yet? This allows fda to review the trial protocol and approve the trial design - it takes 60 days from IND submission.



That assumes that the trial design does NOT use the new rules on adaptive trials which are not supposed to be issued until September.

If the design does use those rules then one may presume that the 60 days won't start till September.