Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-265

glad you highlighted the "would not be eithical" it was much debate at the time about the FDA and its members and the way they acted. some also not declaring the requirement of reporting a conflict of interest.... and given the opportunity to declare that 3 times. ..also in those prior notes.
the FDA contridicted themselve when the still 'suggested' a trial in adult and /or children. ..and then saying it was unethical to do so.. at the time i don't think they used suggested...but required.
the placebo was already established with an extreme death rate and hence easy to see any improvement in that..and NO need for a blind study and give those poor kids and parents a 70% chance of death. .. i would not take that risk myself