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Re: Hoskuld post# 441665

Tuesday, 12/05/2023 5:38:49 PM

Tuesday, December 05, 2023 5:38:49 PM

Post# of 473623
So the p2 b/3 trial ended I think last June and we got the top line data in December. We now have the ole which is scheduled to end on 7/31/24. Data readings maybe 3-6 months then submit an nda. That is a long time if you ask me. They could have submitted the nda some time between say April 2023 and now. The FDA could have done something to speed this up based on the totality of the data. From what I see we will not have this approval before mid 2025 after getting full data months after the end of the trial on 7/31/24. That is where I get my timetable. Thanks. But the good news is Rett should be approved much sooner.
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