CUV 1.61% $14.68 clinuvel pharmaceuticals limited

Fair points, all of the above.I agree that CUV's rem is...

  1. 98 Posts.
    Fair points, all of the above.

    I agree that CUV's rem is excessive and should have - at minimum - been options-based with timing and share price hurdles. However, as shareholders we failed to stop the rem package from being approved. While it irritates me, I think the issue has now passed and it's time to get back to the debate of whether CUV is viable and what it means for the share price.

    Separately, Southern as always some interesting points. In response:
    - You note Wolgen stated CUV expects to submit "in 2011". I was also slightly worried by this: my view is that they will wait until the vitiligo Ph2 results are released before submitting MAA - this would give Scenesse additional scientific clout during the approvals process and would help remove Scenesse's image of being cosmetic instead of therapeutic. If this is true I think it would be the correct approach, but since the vitiligo trials are late starting this may push the EMA submission back further. This statement may be Wolgen's way of signalling this potential further delay.
    - I take Wolgen's anecdote as being evidence that the FDA will require a Phase 3 trial.
    - I have assumed in my own modelling that there will be zero off-label usage due to high price, reg restrictions, and the hassle of prescribing/ administering Scenesse. For me this is my baseline view and I haven't valued Scenesse as a cosmetic product.

    As always, interested to hear your thoughts.

    J-Dog
 
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