Data from the two smaller adult studies will be interesting. However, the larger pediatric Rett study will be the more important one as that study will need to have great results in order to seek FDA approval by 9/30/2022 necessary to get the voucher. Since the approval pathway is 6 months and completing an NDA application takes 6 months, the pediatric study will need to be complete by 10/21 (enrollment by 7/21). Of course data needs to be stellar to try to get approval with just one Phase 2 and there will not be time to do a larger phase 3 and apply by 3/2022. It is unclear if they have actually started the Pediatric study.
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