Yes, very good research there pharmaguy, and I couldn't agree more.
moveonup, sorry I just saw your q. to me - I've been off the board the past couple days due to heavy workload. The analyst report is not even worth a gander. It's the worst I've ever seen on the company. The analyst (maybe that's a stretch) has the most worhtless timelines (they all say Q4 2010 - Q1 2011) for trials. Rubbish. But if you care to blind your eyes with it, there should still be a link to it on Clinuvel's home page.
As for Wolgen's letter:
1) he points out why the stock went from $1.40 to .17, but I don't agree with his explanation in full. While I don't dispute that hedge funds played a role in the selloff, that does not fully explain why the stock is still scraping the multi-year bottoms (forget the 10:1 stuff). While the hedge funds exited, few have been willing to get back in this. Otherwise, it would not still be sitting at the price it is.
In reality, the nonstop delays, missed deadlines (their own), and realization that the high price of the drug will kill off-label usage for all intents and purposes play a huge role at this point.
Will the share price increase if the company gets close to approval? Of course. Will it hit the all-time high of $1.40 ($10.40 now) on mere approval of EPP in Europe? I would bet against it. Good investment from here, but loyal shareholders got hosed since April '07.
And a couple things in the CEO letter didn't sound good to me: they plan on filing in 2011. Gee, that narrows it down. That could mean Q4 2011 - another delay (that wouldn't at all surprise me). 2012 for approval in EU? No wonder such little volume. It never ends.
Also, I am guessing by Wolgen's FDA anecdote that the FDA will not allow them to file for US approval for EPP without a Phase III trial. That is my prediction. That would mean a long Phase III US trial.
I am happy that they are so optimistic about the drug at this point.
Now, there is a real possibility (my opinion here) that the regulators will approve this with limited distribution to ensure it will be even more difficult to use cosmetically (as if the exhorbitant price isn't enough).
God, you would think we're trying to get herion approved for recreational use.
Here's a Christmas message to the FDA from yours truly:
http://www.youtube.com/watch?v=FWBUl7oT9sA
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