I am not claiming to know what FDA will agree to. But it is clear what MSB is hoping for even if they won't risk saying it outright. (They know the danger of raising expectations.) Look again at the language in the annoucement:
"FDA guidance states that reliance on a single study to provide the substantial evidence of effectiveness necessary to support a Biologic License Application (BLA) is generally limited to
***** situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease
with potentially serious outcome for which confirmation of the result with a second trial would be practically or ethically impossible. Mesoblast will submit for formal FDA review the new data analyses
****** showing the reduction in mortality and irreversible morbidity by rexlemestrocel-L
CHF Accelerated Approval !, page-82
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