MSB 2.26% 90.5¢ mesoblast limited

CHF Accelerated Approval !, page-77

  1. 16,792 Posts.
    lightbulb Created with Sketch. 2395
    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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