Mesoblast CC Transcript 31/8, page-9

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    Trial controls.



    My take is we should do the trial this way

    Three groups of salvage therapy SR aGvHD patients

    Group 1 - gets product manufactured for the 001 trial
    Group 2 - gets product from a new manufacturing run, possibly the cells the FDA just observed during the Lonza inspection
    Group 3- Ruxolitinib/Best standard of care only

    1- verifies potency assay effectiveness in the trial lot
    2- verifies potency assay effectiveness in future lots
    3 - Demonstrates superior efficacy to Rux

    100 day survival outcomes , recruit 20 a month for three months


    That's my take on the CC comments , please correct me if I am on the wrong path


    Reg

 
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