CUV 0.64% $13.87 clinuvel pharmaceuticals limited

Ann: Clinuvel - strategic focus of final regulato, page-3

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  1. 131 Posts.
    re: Ann: Clinuvel - strategic focus of final ... SU and PDT weren't huge indications, and if they can save money now by not doing the trials it won't make a huge difference.

    They can always come back to it later if the market is big enough.

    I liked this bit:

    "EMAs Committee for Human Medicinal Products (CHMP) considered Clinuvels existing preclinical package,
    accompanied by ongoing studies, adequate to support Marketing Authorisation (MAA)."

    Hopefully the "ongoing studies" doesn't include the confirmatory trials (they haven't started, so they're not "ongoing", and the confirmatory trials weren't supposed to be finished before an application for MAA anyway).

    If so, this implies an application for MAA within a couple of months after the full EPP results are released.
 
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