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Re: hoffmann6383 post# 514753

Sunday, 09/18/2022 9:47:39 AM

Sunday, September 18, 2022 9:47:39 AM

Post# of 819394
hoffman6383,

Working under the exceptions rule to adequate and well controlled trials is a delicate matter because all rests on final “approval” of BLA that is the final validation of SAP, ECAs and endpoint changes as necessary and adequate. When you understand this then you understand the points of attack. Best wishes.
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