MSB 0.00% $1.57 mesoblast limited

CHF Accelerated Approval !, page-77

  1. 17,193 Posts.
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    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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