Ann: Mesoblast and FDA Align on Key Items for Revascor BLA, page-129

  1. 1,752 Posts.
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    Hi @Bazsa,

    yep. I don't know how FDA reviewers can sleep after letting RUXOLITINIB's clinical evidence through without questioning these numbers, either effectively at the time or since.

    It's even more 'graphic' IMO when depicted graphically, as extracted from the authors' Supplementary Materials below (link here):

    https://hotcopper.com.au/data/attachments/7122/7122062-0a825e4fd270c936eee588387bf29106.jpg
    and

    https://hotcopper.com.au/data/attachments/7122/7122065-968c10b2bd22a4f4f23b3ae8329c38a9.jpg
    They mixed it with steroids & even then that hazard ratio of ~91% indicates there was barely a <10% relative occurrence risk difference between the 2 sets of datapoints that they took out of the randomised trial.

    I'd be keen to hear Dr Vinay Prasad's view of these numbers. He's had a thing or two to say about the importance of demonstrated OS to the FDA as he sees it going forward.

    We'll see.

    Cheers
 
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