PER percheron therapeutics limited

Sarepta FDA Hearing, page-9

  1. 4,690 Posts.
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    The FDA options are vast.

    They can approve.
    Thdy can reject the drug and remove it from sale.
    They can require more data, change trial endpoints etc.

    Because the the safety issues have been addressed, i would guess on redefining endpoints and trial with mire data required. But that is an unqualified guess.

    We find out soon.
 
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