This really puts Mesoblast on the map. It’s the perfect time for a big pharma to partner up, Msb has done the hard yards it’s at the sweet point for a BP to jump in at a low risk to either run another trial or confirmatory trial prior to approval and hitting the market . I can’t see the FDA giving accelerated approval especially missing the main (minor) endpoint of hospital visits, I understand the argument to that being we hit a home run on secondary (major) endpoints but as we’ve seen with the fda they’re.. “hard to please” . I can see them saying “good results, now prove it with a well conducted smaller trial focusing on the right patients and MACE reduction which is still a great outcome. Again the hard work is done Mesoblast have all their data and a better understanding of their cells a narrowed down specific trial should be a hell of a lot easier to design (hopefully with a BP by their side) good luck everyone
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