First on the ADR: clvly is, for now (Monday morning), back to...

First on the ADR: clvly is, for now (Monday morning), back to trading without any reversal factored in. That might change again this week (back to $17-$18 or so). It was really acting spastic last Friday, thanks to the market maker.

Yesterday's Clinuvel newsletter is very encouraging for those with a long-term view. We know that it's the regulators holding up the commencing of the vitiligo trial. At least there's clarity on that issue.

Per the cuv9900, as suspected, it's not a systemic drug and all signs point to some sort of cream, gel, or liquid as one of the delivery methods (my prediction here - the company has not confirmed that yet). The company has hinted repeatedly that there is additional shareholder value in this. The problem is that cuv9900 is just in its infancy, so that won't appease those shareholders who have a short-term outlook. And most investors today have a short-term outlook.

Wolgen made the most eye-opening statement yet on his confidence of Scenesse reaching global approval in the newsletter. Somewhere, a certain dermatologist in the US who has not had very good things to say about the drug is probably disheartened to read that. The supporters of Scenesse among the medical community now seem to far outweight that rogue doctor's views.

Finally, it appears to me based on the commentary in the newsletter that management now knows whether they will need to do a Phase III trial for EPP in the US based on the feedback from their FDA meeting. It would be big news if the company could file for EPP approval in the US based on the EMA dossier and the Phase II results for EPP in the US. While I believe the company probably knows the answer to this, we'll all know around March or April 2011 or possibly sooner when they would have to begin rounding up Phase III study participants. If we don't see the APF seeking Phase III participants by that time, then it would be a good sign.

Three months to review the EPP data and prepare the dossier is not a problem - that is standard. What would be a problem is if it all gets dragged out several more months than advertised. At this point, the market will respond to actual achievements 'in the can' (as they say in Hollywood), rather than statements of what shareholders have to look forward to.

At least the drug will be approved. I've seen more than my fair share of complete bombs in the biotech sphere. Seventeen cents per share is better than three cents per share - something that investors in companies like Alexa experienced.