It's not zero, otherwise it'll be risk-free and those studies were not properly controlled. There are (of the top of my head) two placebo-controlled studies that i've come across using MSC's which showed no improved survival benefit in ARDs. Now sure there are limitations associated with these studies, which Mesoblast appear to have addressed, but there is certainly a chance for futility.
Overwhelming efficacy - the stats required, page-195
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