OK, where in this statement do you see the words "accelerated approval"
"Mesoblast will submit for formal FDA review the new data analyses showing the reduction in mortality and irreversible morbidity by rexlemestrocel-L in HFrEF patients with diabetes and/or myocardial ischemia, to agree on a potential pathway to approval"
Where did the idea come from? Somebody started a thread with this title.
Yet it doesn't fit with the statement from MSB
CHF Accelerated Approval !, page-79
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