MSB 2.51% 97.0¢ mesoblast limited

Australian newspaper article, page-163

  1. 2,769 Posts.
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    WOW- correct JB1975- great pick up.

    In the share caf webinar early March Si does say that they were going to present new data to the FDA at the forthcoming March meeting.

    This weekends interview has Si saying that the FDA no longer required any more data- that they had enough already for approval in kids.

    So timeline was
    September Type A - FDA requests more data
    January more data provided and apparently even more data requested
    March 8th Share Webinar - Si saying giving extra new data to the FDA at a meeting later this month
    March 26th- minutes announcement from the January meeting- FDA saying existing data , after additional consideration, appears sufficient.

    So the NEW data was no longer required- indeed, not even submitted! The FDA has come to the party - this is freaking huge!

    @otherperspective@Phaedrus@Pharmagang I think I'm right- your opinions most valued


    My view had been that the latest data got us across the line- NOPE- not even needed, the company's reverse in strategy occurred without it



    Happy Reg
    Last edited by reginaldp: 12/06/24
 
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