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Re: bas2020 post# 429155

Sunday, 09/03/2023 12:46:44 AM

Sunday, September 03, 2023 12:46:44 AM

Post# of 462418
I had timed the AD peer review article for shortly before the FDA has to come to a decision on accelerated approval for AD. It seemed to me that would also meet the supposed typical average of 21 months delay from trial end to peer reviewed article about the trial. So I think I figured May/June of 2024 for that publication. I thought we'd submit for the AD NDA a month or so after we submit the same request for Rett. I think we do Rett October/November. Get it approved for FDA consideration by year's end and then a decision (PDUFA date) June/July on Rett. AD will take 9 months rather than the 6 for fast-tracked Rett....and so we'd get an AD PDUFA date around a year from now - September 2024.
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