All this argument about how trial data should be analysed or how many patients have survived is pointless. It doesn’t matter what any of us think, but what the FDA thinks. The FDA does not often approve medicines on the basis of post hoc analysis.
For the record I actually think MSCs work, but that MSB has not proven this to the require FDA standard. I am not confident that MSB will fair any better this time than they did with their last BLA. I hope I am wrong.
MESOBLAST CURES SR-aGVHD IN CHILDREN, page-60
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