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Thanks Crispy.What I meant was - none of the P2b outcomes...

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    Thanks Crispy.

    What I meant was - none of the P2b outcomes required an extra P3 study BEFORE FDA approval. Confirmatory studies, while we are able to commercialise (sell), are not P3 trials AFAIK (although they may be of the same size I imagine).

    If we have commercial approval and are able to sell our PRV as a result (as well as our drug for DMD), a confirmatory trial will be a cinch financially and objectively assuming we can replicate our P2b success.
    Last edited by BoomCrashOffera: 29/08/23
 
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