Not sure we know that the FDA "agreed" with the revised SAP. I am assuming that since the company is moving forward with data lock and unblinding, they (the company) are comfortable with the comments from the 4 RA's. They stated that the steps included the revised SAP and submission/comments. They stated they have only one chance to get this right and want all possible input and understanding before locking. What that means for FDA "agreement" I don't know. What is does mean is that we are past that step and onto data lock and then unblinding. I take that as the company being comfortable with SAP and comments.
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