CUV 0.27% $21.85 clinuvel pharmaceuticals limited

..interesting point of view..

  1. 1,363 Posts.
    Thought all the ept investors might be interested in this point of view.

    Author "InTheGroove" source - ozesock 31/10

    " don’t think the delay in FDA minutes is anything to worry about. My best bet for why EpiTan haven’t commented on the meeting as yet is due to a matter of context and strategy.

    Before the iib results were announced, EpiTan only had the phase i/ii trial to fall on in that Melanotan is safe to use on humans and that it causes a tan to develop. There was no clinical evidence or proof of sun burn protection.

    The FDA probably advised EpiTan that it would be reluctant to approve Melanotan for the purpose of “Tanning”. However would approve Melanotan for the purpose of “Skin damage protection” ie a prescription sunscreen for Fitzpatrick skin types 1 perhaps Fitzpatrick type 2, and other dermatological disorders such as psoriasis, vitiligo, polymorphous light eruption and solar urticaria.

    The various cancer institutions and organisations will not want to “promote” or advocate “Tanning” as being something to desire. In fact, many educational and advertising dollars have been spent trying to convince the population that being white is both healthy and safe and that a tan is a sign of skin damage and something to avoid. I just can’t see the FDA approving a drug for a sheer purpose that goes against this agenda.

    I think this is why EpiTan put out the phase iib “sunburn injury” trial results before the FDA minutes. So show that EpiTan has a clinically proven sunscreen drug for an approved market use. If EpiTan did the FDA announcement first, then the market might of panicked as EpiTan would have only had evidence of something not approvable in the short term.

    This also makes sense when you consider EpiTan is lodging new patents for sun burn injury protection. They realise that the owning the right of Melanotan for protection rather than colour is where the money is! Eventually a genetic version of Melanotan some years down to the track might cause you to get a tan, but only EpiTan will have the patent on sun screen use. Smart! Smart! Smart!!!!

    Additionally, look at EpiTan’s website on the section on “Market Potential”. It has changed to market Melanotan as more of a sunscreen rather than safe cosmetic “sunless” tanner. EpiTan have also renamed the market potential sentence on the bottom of their announcements to this affect.

    With US$2.5 Billion market for dermatological and say another billion or two for prescription sunscreen use, will see EpiTan worth a fortune regardless of the restrictions placed by the FDA.

    I reckon the FDA announcement will be very soon.



    Do your own research, and good luck to the investor.
 
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