LoL You read this
"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"
and come up with "accelerated approval for CHF!"
I read it and come up with
"Mesoblast asks the FDA if they would accept the cherry picked data from their failed trial as the basis for a design of a new trial using a reduction in morbidity and mortality as the primary end points.
That is "a potential pathway to approval". Even Dr Perin acknowledged a new trial would be needed and an expert review panel from the conference were not very impressed because there was no obvious mechanism of action since cardiac function wasn't improved.
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- CHF Accelerated Approval !
CHF Accelerated Approval !, page-77
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