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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-548

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    Hi JB1975- you refer to EAP patients and confounding variables. My understanding is that the new potency data is generated only from the 001 clinical trial- which removes the confounding variables. If Si was allowed to submit real world evidence from EAP patients I can see your point. But I think it is purely potency data from an assay that was in place at the time the 001 trial was conducted.

    The trouble is (one of them - there are probably about three at least) EAP patients are treated at physician discretion - and physicians tend to treat their patients differently from one to another which introduces confounding variables.



    Reg

    Last edited by reginaldp: 11/04/24
 
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