Thursday, January 06, 2022 1:32:03 PM
Stats should be given with 700mg data as that was the trial, a double blind placebo with one arm getting 700mg and the other getting placebo. Recknor added the OLE arm at 350mg but (my assumption is) because it wasn't actually part of the trial the stats don't matter to the FDA other than comparing for dosing justification. The FDA wouldn't accept them, they'd want to see the 700mg data. Is there a single study where the 350mg doseage has outperformed the 700mg doseage? If not then it should be expected that the 700mg will at least mirror the 350mg here and hit the primary endpoint and that's the one we'll see the data on.
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