Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-184

design of trials is a complex matter, I doubt many of us here really get what the FDA does with them, nor what they advise in there design..
It was said, when designing the heart failure - the FDA indicated it was more interest in the secondary end point of mortality. ie lives saved, not so sure or clear why then that wasn't made the primary ? i suspect days in hospital etc looks more appealing to insurance industry or and show a better the current practice outcome, then the why has been talked about a bit with the trial - why primary endpoints were settle on adn that decision looked incorrect judge.
over a 3 4 6 year trials, the environment chnages as does technnologies- therefore the some flexibility in trial data and approvals shoulld be that too.
already we have seen Vac, gilead amonng other that get approval without full data ... and why?