CEO Itescu needs to go, page-812

@Phaedrus, Your post raises three questions for which I'd be interested in your opinion:

Dr Kurtzberg's objection to an RCT in children was that it would be unethical to subject children to a placebo control. So, 1) why couldn't your suggested externally controlled, non-randomized, no-placebo-involved trial just be performed in children? Why introduce a new variable by changing to adults?

In October, 2020 the Company said this: "the FDA recommended that Mesoblast conduct at
least one additional randomized, controlled study in adults and/or children to provide further evidence
of the effectiveness of remestemcel-L for SR-aGVHD."

Such study has not been done, so, 2) why would the FDA no longer require a randomized trial?

Also in October 2020, the Company said this: "Mesoblast will urgently request a Type A
meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a
post-approval condition for an additional study." Subsequently there were additional meetings with the FDA. So 3) if the only obstacle to approval is a small, quick, targeted, non-randomized, externally controlled study, shouldn't the need for that have been discerned at Type A meeting #1? One would think they might have discussed specific requirements/hurdles to be crossed for approval back then. At least that's what we were led to believe by interim reports. Your opinion?