major news - good and bad

Well, as I predicted on this forum multiple times, they will not file the MAA in Europe until 2011. Everyone who is shocked by this delay, stand on your head. Another deadline missed.

They were initially saying they would have this in 2009. Wrong. Then on their website earlier this year, they said it would be filed by the end of the year. Wrong. And what really ticks me off is they said even in the past couple weeks it would be filed by the end of the year. Wrong. Now they say 2011 ? and the 2nd quarter at that.
Funny how in my last post on this subject, I said I would even be inclined to move my prediction from Q1 2011, to the 2nd quarter. And low and behold...

Now let?s trace the history of this. Last September, Clinuvel released a podcast where Agersborg said they would file the MAA concurrently while doing the confirmatory trial in Europe. Then in November, Wolgen, in a Corporate File interview, hints that they might not file right away upon completion of the initial Phase III trial. So the share price has been in the gutter ever since.

There were several people on this board back in November that posted that they just sold out and were done with this after that Corporate File was released. I also unloaded a good amount then as I could see the writing on the wall ? there was not going to be a MAA filing anytime soon. And it proved to be true.

Now the other major thing to me is that there is NO mention of the PLE trials in the latest strategic update. PLE is the gateway to blockbuster potential. Without it, Scenesse is for EPP and possibly Vitiligo. Well, vitiligo approval is years away even if it happens.
So, the analyst said he projects Scenesse will cost Euro 1,500 even after approval. So that?s about $1,900 US dollars. He projects the price would only decrease about 2 percent per annum. That?s nothing.

If anyone thinks this will be a blockbuster for off-label at that price point, get real. In this economy (or even in any economy) most people (those who don?t have EPP or vitiligo) will not pay $1,900 for a 60 day tan. Insurance will not cover off-label usage.

Now IMO, all this explains why the share price is at .22 and has been below .30 for a very long time. The constant missed deadlines, the seemingly never ending pushing the goal line forward, along with the fact that there is not a huge market for EPP. And at that price point, good luck getting a ton of off-label sales.

Many people would still go to tanning booths or use a self-tanner. There are now tons of tanning parlors where you can get an all-over spray tan that are gaining in popularity. There will still be many people getting Melanotan II off the black market as well ? it?s much cheaper. Should they? No, but it will continue if the price point is this high.

I don?t know what is going on with the PLE trial, but if they decide to drop PLE because of whatever reason (lack of impressive results, etc.), that is really bad news. PLE was much closer to approval than Vitiligo will be. So the price point would probably stay high (it would just be approved for EPP) and that would suck.

Now there is potential good news:

1) They made some reference about the European trials possibly being enough for the US (in the regulatory strategy section of the latest release). We have to hope that is the case. Since the FDA would not allow them to proceed directly to Phase III in the US earlier this year, I can?t see them getting FDA approval without some Phase III trial. But that?s just my instincts.

2) The new molecule is good news. The mention of ?various new formulations? could mean some kind of cream or lotion. BUT, that is all years down the road even if it pans out.

So they now say the drug might be approved by the EMA by the end of 2011. Will this ever end? I can see why the share price is so low. I can?t speak for people on the sidelines but I?m guessing they feel there is not hurry to get in this.

We've outlasted employees, board members, chairmen and chairwomen of the board, and what do we have to show for it?