MSB 2.08% 94.0¢ mesoblast limited

MSB to dispute FDA finding in Type A meeting, page-292

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    Instigation of a confirmatory study is needed at the time of application for consideration of the accelerated option.

    The availability of ryoncil for kids would make it diffuclt to enroll further studies therefore confirmatory study in different population (ie adult).
    https://hotcopper.com.au/data/attachments/2528/2528456-f4db46589ac94757dda897cc53c7878f.jpg
    Last edited by Stellowe: 04/10/20
 
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