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10/29/20 2:53 PM

#279296 RE: Gernee20 #279288

yes. Most likely scenario, IMO, is that the 2b/3 will enroll by Feb/March 2021 and complete in Jan/Feb 2022. Another 9 months to analyze data and set up and initiate the Phase 3, 2 years to carry it out (maybe with screening out S1R Q2P mutations) will be end of 2024. Then, assuming good results, 6 months to prepare NDA application and 6-9 months at FDA and EMA

Rett has potential to submit an NDA in 2022 if the pediatric study has outstanding results.