CHF Accelerated Approval !, page-80

SI communicated to shareholders that it was the FDA that asked Mesoblast for the group of patients that would most benefit. This is at odds with your read "Mesoblast asks the FDA..."

It is nearly a given that if a new trial is required that a reduction in cardiac mortality and morbidity and cardiac death would be the primary endpoint.

I agree with @LearningEachDay that the FDA may well be considering accelerated approval for diabetics and ischemics. Remember that MACE is an acceptable endpoint for approval and we aced it in that regard. It is not out of the question IMO that Rex-L is being considered for accelerated approval on this basis. Worst case we know the patient population to target and the primary endpoint for the next trial if required.

Soon enough we will have the answer.