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Ann: PIIb DMD trial approved in Bulgaria- UK, Australia advancing, page-25

  1. 13,117 Posts.
    lightbulb Created with Sketch. 1370
    I just had a light bulb moment !
    Could it be that our chair CG has been in talks with us he FDA .
    Because of the Urgent need for the DMD population
    and our fantastic results from our last DMD trial
    The FDA agreed that the end points will be what we achieved PUL -2 in the last trial.
    So with the 9 month Tox study already underway and the 12 month study in Belgium, Turkey , Uk and Aust
    being completed and successful: it will be enough to market in Europe and the US.
    To me : it makes sense.
    Great for the DMD population.
    This is only my opinion/ have a gut feeling that this is what will happen .

    Last edited by itsagas: 26/04/23
 
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