Ann: Media release - FDA allows world first vitil, page-2

re: Ann: Media release - FDA allows world fir... Well, as I said yesterday here, we were definitely due for some news this month.

This is very significant news. If the vitiligo trial goes well, the stock will definitely be re-rated. However, they will still have quite some time before the drug would be approved for vitiligo.

The real wild card would be if doctors would use the drug off-label to treat vitiligo even when it is just approved for EPP. There's a lot of questions to that because Clinuvel will control the supply of the drug - hence, they could limit its distribution initially. Then there's still the high initial cost of the drug until it would be approved for PLE or vitiligo itself.

We still are waiting for the FDA to approve the start of a Phase III EPP study in the U.S. It would be a shocker if the FDA allowed Clinuvel to skip phase III even with the European data. I certainly don't expect it.

We also need to hear the details of cuv9900.

There is a chance we will get another significant piece of news in March.

If the company can get this approved for vitiligo or PLE, then the stock will be multiples of the current share price. The market just isn't all that hot with the EPP alone.