the decision to proceed "without a randomised trial" was based on advice from the FDA and the medical community basing the randomisation in kids with a mortality rate of 70-90% unethical.
such a master stroke.... maybe we should have just let the kids die and gained approval.
IRENE KRISTAL, I, Plaintiff, v. MESOBLAST LIMITED, SILVIU ITESCU, and JOSH MUNTNER, Defendants., page-166
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