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Re: Hosai post# 466333

Sunday, 08/04/2024 1:21:37 PM

Sunday, August 04, 2024 1:21:37 PM

Post# of 517128
Doc is proving too much by arguing that a CDR-G score of 0.5 doesn't really fit within the criteria of the draft FDA guidance for stages 1 to 3, because it leaves no situation in which the CDR-G scale can be used by the draft FDA guidance. Why would the FDA even bother to propose to change course in endpoints if, in practice, it couldn't be reasonably applied?
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