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Re: Doc328 post# 462198

Sunday, 06/23/2024 12:08:16 PM

Sunday, June 23, 2024 12:08:16 PM

Post# of 474354
Any thoughts on why CGI-I wasn’t listed in trial design but was presented here as an exploratory endpoint?
It’s worthy noting there is no company PR so far (maybe on Monday) if it’s considered material event of announcing full dataset or change of TLR.
Any example of a completed clinical trial with only one co-primary endpoint statically significant (but not the other) able to submit a NDA (or adjust the SAP) based on FDA guidelines change?
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