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clock Created with Sketch. 13/11/24
21:15
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Originally posted by GazBusey:
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Rewatching this the Q&A gives some good insight into Stamler's thinking on 201. That he does feel that 201 could support an accelerated approval, but it wouldn't be off iron reduction alone, that perhaps FDA would accept reducing brain volume loss. Surely these would need to line up with UMSARS too.
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Yeh there were alot of concerned holders back than, stating they shouldnt change the endpoint as it may not cross the line if it doesnt show change.
(20min delay)