My thoughts?
There is no doubt in my mind that MSB, as the sponsor and with very experienced staff on board, fully understood the risks in proposing a single arm trial, especially when two previous properly controlled randomised clinical trials (including some children in those trials as well as adults) failed on every count.
And there is no doubt in my mind that FDA would have cautioned MSB at one or more stages, despite the fact that it would have been obvious to all participants.
As @whytee has pointed out, even MSB has acknowledged that the control data "may or may not be accepted by the FDA".
Why Meso is pumping today?, page-36
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