Ann: Mesoblast Maintains Momentum with FDA, page-55

  1. 5,622 Posts.
    lightbulb Created with Sketch. 9446
    bad outcome of Revascor BLA meeting would be that the FDA does a backflip and requests more data. No sign of that.

    good outcome is that we continue as expected, and proceed down the path of least resistance and simply receive feedback from the FDA and proceed with filing later this year.

    baring a fundamental disagreement, which Mesoblast would consider to be significant enough to delay a filing, then a non-event outcome is all we really need right now. This announcement gives the vibe of a no surprises outcome, no bells and whistles needed.

    seems we could have a Revascor AA filing, adult Ryoncil trial recruiting, CLBP trial completing recruitment (22location now) and Ryoncil sales ramp up to look forward to the second half of 2025….

    that’s a nice pipeline and we are still trading below pre-approval levels…

    goodluck all!

 
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