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Friday, December 03, 2021 12:16:27 PM
As for the SAP, rejection would also have been a major event. Nothing disclosed. They said they would proceed when all the agencies accepted. And as you know, the FDA accepts with silence. They and any regulatory agency retains the right to assess with final data, however, survival is the most preferred outcome, especially when accomplished with the least side effects. So moving from a surrogate primary for survival to actual ongoing survival, rejection is not likely in my opinion, and it is doubtful to me that the other regulators would accept without the support of their primary regulator, which is the FDA.
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