Yes. I've seen them vote on three questions before. Essentially the committee will be asked to vote on any questions the FDA deems to be potentially standing in the way of approval. This is because the committee is independent, while both the sponsor and FDA are biased.
The discussion points were to figure out what MSB needs to improve on, possibly as part of post-marketing studies or prior to achieving approval for other indications.
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Yes. I've seen them vote on three questions before. Essentially...
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