MSB 2.89% $1.25 mesoblast limited

2023 The Final Countdown, page-17

  1. 468 Posts.
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    My estimate is the following:

    • On or before 15 February 23, FDA acceptance of BLA resubmission (estimated).

    • 27th February 23 - CHF peer reviewed article released in JACC.

    Within mid April I am expecting the following:
    • Partnership announcement.
    • CLBP recruitment starting in USA, followed later in EU.
    • CHF meeting with FDA complete by now and possibly an Accelerated Approval.

    Mid April to 1 July 23 - Approximate range of PDUFA dates
    = Approval.

    PDUFA should be known in mid February.
 
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