The concerns of the FDA are there for MSB to provide their responses. I feel confident that SI and the team would have been anticipating these questions. You do not prepare a commercial team readying for approval if you have not dotted your “i’s”or crossed your “t’s”.
FDA does not just approve without putting forward any concerns, which is up to the MSB to provide clarity which you would expect the team would have been preparing to do!
GLTAH.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-484
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