Bouf - Having lived through the 2013 adcom and having gone through the transcript and recordings multiple times, I think the FDA will probably approve the label expansion promptly. They do what they perceive to be in their self-interest. After some other CV outcome trials failed (niacin/fibrates), FDA decided to rescind the SPA and avoid risk of another embarrassing post-approval trial failure.
RI results are a grand slam home run, and FDA knows it is in their interest to approve promptly. Nothing's ever ever completely certain with them, and they may find a way to make it a bumpy path, but I think the RI SPA will be among the 98% that are honored.
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