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Re: Investor2014 post# 402425

Thursday, 02/09/2023 12:14:14 PM

Thursday, February 09, 2023 12:14:14 PM

Post# of 463674

That will give an insight to how low the bar is.



The bar seems to be modest but statistically significant on the prespecified co-primary endpoints of change in RSBQ and CGI-I. Whether Neuren/Acadia set a higher bar with the FDA by having a study with 187 patients rather than 92 is unclear. They did have an SPA so they knew in advance that the trial size, duration and endpoints were acceptable for approval.
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