Actually they had the task of trying to divine whether or not the opinions expressed by a group of witnesses that SI lined up might have some validity.
But the FDA couldn't accept that level of evidence as proof that it works. You may recall from an earlier post that expert opinion and case studies are the lowest forms of scientific evidence. Its far from proof that it works, and that is the reason the FDA rejected it and requested that Mesoblast go back and do an RCT.
Deadline for Novartis, page-37
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