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sumbuysumsell

12/16/23 9:59 AM

#442860 RE: Steady_T #442852

Thanks. Interesting.
I thought it was possible that this was a new requirement resulting from a rolling review but if i understand you are saying it was an existing requirement that was missed by the CRO.
My understanding is that Fast Track designation exists for Rett. With this in mind, do you think a rolling review of an NDA might be currently underway? I can't see any reasons as to why not.
Thanks again.