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boi568

08/04/24 2:39 PM

#466349 RE: Doc328 #466339

I am responding to your conclusion that blarcamesine cannot benefit from the revised FDA guidance. I have not seen Sabbagh reach that conclusion.
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frrol

08/04/24 2:43 PM

#466353 RE: Doc328 #466339

Based on that paper from Sabbagh et al, you have a point. So Sabbagh may not agree with Missling on the new FDA guidance and might explain why, despite Missling's mention of the attractive new guidance, we have still not applied for an NDA. I suspect this could be clarified with an FDA meeting: do we meet the new guidance? I'm sure the company is pursuing that, or has.