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clock Created with Sketch. 10/06/25
11:38
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Originally posted by reginaldp:
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How about an AA for Adult SR aGvHD - at first sign of promise- how many hundreds are alive because of access via EAP?Newly installed at the agency, Vinay Prasad has committed to giving rare disease patients rapid access to “products that are even small steps forward” during his time as director of the FDA’s Center for Biologics Evaluation and Research. “We will take action at the first sign of promise for rare diseases. We’re not going to wait,” Prasad said.
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Reg I agree again it makes sense with new FDA mandate and PK's relationships that AA for adult GvHD be granted with low hurdles for approval.
(20min delay)