No they could not, but they did change the age composition of the trial. Death rates of children receiving SOC in those days was already known and probably not as good as it is now. All children were pulled from the trial and placed in the EAP trial, so all on placebo still alive got the real deal.
Somewhere there is a video probably from the Vatican conferences I think, where Dr Donna Skerrett, the former Mesoblast CMO, discusses that decision.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-170
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