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Ann: Antisense Therapeutics Corporate Presentation, page-46

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    None of the outcomes in the preso had a larger trial (P3) being required, so approval based on P2b positive results (albeit maybe a subset approval or requiring a confirmatory study) was implied.

    Besides, George said Charmaine had been told by the FDA.

    My experience with Bureaucracy is that butt-protecting decisions often trump logic.
    Last edited by BoomCrashOffera: 29/08/23
 
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