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Re: sage4 post# 453750

Friday, 03/08/2024 4:58:07 PM

Friday, March 08, 2024 4:58:07 PM

Post# of 458855
I would imagine, sage, that there was some dialogue with the FDA in the second half of 2023 when he could have brought up that idea you alluded to, AA with the OLE serving as a confirmatory trial. Again if I were guessing, he got some push back on that, so we have the more recent statement from him (in a conference call Q&A?) that the OLE would be part of the NDA package.
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