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Post# of 252792
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Re: marthambles post# 244868

Wednesday, 12/28/2022 12:26:37 PM

Wednesday, December 28, 2022 12:26:37 PM

Post# of 252792
RVNC - Yeah, their marketing material seems a risk. They have a big advantage in duration (between 60 and 75%) and it seems odd to push past the boundary of the FDA approved secondary endpoints (which use loss of either patient or provider assessed benefit counts as loss of benefit - whereas company, and published papers, use maintenance of either as 'still meet criteria').

Comment: I don't know legal/regulatory history on this, but it was a little surprising they don't use return to baseline, which is actually a prespecified secondary endpoint in ClinicalTrials, seems to actually be longer and is also in a published paper?
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