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Re: BAR123 post# 390954

Friday, 12/09/2022 7:28:58 AM

Friday, December 09, 2022 7:28:58 AM

Post# of 463688
It is unlikely the resulting 50mg subgroup to be large enough to secure approval on its own. We are looking at a sample of around 120-140 treated patients only which is likely to be considered insufficient on its own to gain approval for an indication such as AD. If the results are encouraging though from this subgroup, it could lead to a new trial with around 500-1000 patients that could study only a 50mg dose given before bedtime to reduce adverse events and maybe focus on a single primary cognition-related endpoint (e.g., CDR-SB) as 2-73 seems to help more with cognition than function.
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