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Ann: Mesoblast to File BLA for Ryoncil FDA Approval Next Week, page-105

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  1. 560 Posts.
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    Why did SI used word 'For approval' in the title? I checked the Jan 23 announcement and it didnt have ápproval' word in it. As far as I know, approval word was never used in any of the previous BLA submissions (please correct me if I am wrong) See below.

    Do I conclude that this time is guaranteed or some kind of assurance from FDA that approval is sure thing! Just my personal opinion and not a financial advice.

    Ann: Mesoblast to File BLA for Ryoncil FDA Approval Next Week (yesterday)

    vs

    MESOBLAST RESUBMITS BIOLOGIC LICENSE APPLICATION (BLA) TO FDA FOR
    REMESTEMCEL-L IN CHILDREN WITH STEROID-REFRACTORY ACUTE GRAFT
    VERSUS HOST DISEASE (SR-aGVHD) (January 23)

    vs

    MESOBLAST INITIATES ROLLING SUBMISSION OF BIOLOGICS LICENSE
    APPLICATION (BLA) TO U.S. FDA FOR REMESTEMCEL-L IN THE TREATMENT OF
    ACUTE GRAFT VERSUS HOST DISEASE (May 29)
 
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