CUV 0.07% $14.94 clinuvel pharmaceuticals limited

More great news for Clinuvel, and yes why indeed not price...

  1. 801 Posts.
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    More great news for Clinuvel, and yes why indeed not price sensitive? A quick search below comes up with 4 concrete examples of Orphan Drug Designation being granted and EACH ONE IS MARKET SENSITIVE as marked by the ASX. I could go on because there are plenty more but why the inconsistency. So what does Orphan Drug status do, it usually means tax credits for trials, a market exclusive period and less or no fees throughout the drug approval process.

    Mesoblast MSB 15/02/24, Neuren NEU 3/9/21, Noxopharm NOX 4/10/23, Argenica AGN 15/11/23 All market sensitive but not CUV 29/4/24?

    In my opinion this is very likely to be added as a label extension for the already approved and safe drug. Clinuvel did mention payors will reimburse for this terrible disease and the following statements in todays release are quite positive:

    "The Committee for Orphan Medicinal Products (COMP) recognised the chronically severe nature of skin
    symptoms in VP, the high unmet need, lack of alternative therapies, and afamelanotide’s potential as a VP
    treatment.

    The EMA considered clinical evidence from the CUV040 study – an open-label six-month study of six adult VP
    patients – to be a sufficient proof-of-concept to enable a positive opinion on the ODD application for
    SCENESSE®. The Agency reviewed the study endpoints and results on disease severity, ability to expose to
    light, and quality of life as a potential clinical benefit for VP patients."



    All IMO DYOR


 
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