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3.19% 97.0¢ mesoblast limited

Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-363

  1. Grainger
    207 Posts.
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    13/03/24
    22:19
    Post #: 72872086
    they explicitly said they couldn't consider the successful phase III trial as adequate because the potency assay that was used was not consistent and reliable. if the new data prove out the potency assay that was used in the study then it could be considered as adequate. no need for another trial in that case
    MSB Price at posting: 37.5¢ Sentiment: Buy Disclosure: Held
    Likes Created with Sketch. 9  Upvote
    lightbulb Created with Sketch.  Great analysis
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