The SAP is a document prepared for submission to the FDA. Why does the SAP have to tell the FDA that the FDA required something? The FDA knows.
The reason for the crossover is not the FDA requirement. The reasons were for recruitment and retention which could be achieved by allowing access to the drug. In other words, nobody would sign up unless the doctors would actually take care of them appropriately.
The fact that the FDA required it is beside the point and irrelevant because the investigators would have designed it that way anyway.
Webinar with Dr. Linda Liau December 5, 2022 8:30 PM Eastern Time Topic: DCVax-L (murcidencel)
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