I think the crux of the complaint is that the company was overly confident in their statements when they should have highlighted the fact that the FDA might well have concerns about the comparison controls and how they were derived. That one sentence buried in the report that @Southoz mentioned was actually highly significant, but pretty much overlooked and few would have understood it's implications. And now it appears to be the reason the trial result is unacceptable to the FDA.
IRENE KRISTAL, I, Plaintiff, v. MESOBLAST LIMITED, SILVIU ITESCU, and JOSH MUNTNER, Defendants., page-93
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