Thanks, @LearningEachDay and@Armyne I think the additional trial will be requested because of the large future treatment numbers involved, not to mention the worldwide media scrutiny on a brand new treatment which, stem cells in general, have a checkered past (umbilical). Personally, I hope they do it on a 1000 person sample, with multi-country sites, with dose exploration on those above 65. The P values are good, very good, and I don't buy the multiplicity argument, dead v's not dead is the most rigorous endpoint you can get.
Thanks, @LearningEachDay and@Armyne I think the additional trial...
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