CUV 0.85% $15.37 clinuvel pharmaceuticals limited

deciphering the ceo letter, good and bad

  1. 648 Posts.
    My take on Wolgen's CEO letter to shareholders yesterday is mixed in terms of good news and bad news. I'll lay out my reaction to it. First, I'll start with the bad news and then finish with some hopeful news from the letter:

    Bad news:
    1 Once again, that use of the word "shortly," which is the management team's favorite word. Results of Phase III will be released "shortly." As in the opening of the NJ office will happen "shortly"? That was 'shortly' 18 months ago. And it still hasn't happened.

    Results from Phase III were due in Q1 according to their Q1 announcements. We are now in Q3. Delays happen, but if results aren't coming very soon, investors will rightly be p.o. They are already 3 mos. overdue by their own prior announcement. Sorry, but since the company is the one behind the drug and the trials, this was a poor initial forecast. I'm not sure how outside entities could be the reason for such forecasting gaps.

    2. Based on the wording in the CEO letter, I am still convinced that Wolgen will wait to file the MAA until all of the confirmatory EPP trial data is ready. Given how long it has taken to get out the initial Phase III results, I still say they will not file the MAA until early 2011 in Europe. And since Phase III in the USA cannot begin until next spring/summer in the Northern Hemisphere, I am sure a lot of investors in the sidelines are in no hurry to get in this. The incessant delays not helping the share price. If the company still says the MAA will be filed by the end of 2009, I would say, "OK, prove it in the next 6 months." I will be happy to be wrong on this.

    Good news:
    1. Operations are in the process of picking up in Europe and the US. And this is driven by need (if trials weren't going well, they would not be ramping things up).

    Wolgen?s wording sounds like there is something extra brewing that is causing the need to have additional operations going in Europe ? and perhaps beyond just the EPP trial. Wolgen?s wording states ??as well as other developments.? That is intriguing as it states that possibly there is a new reason why they need to ramp up staff and operations in Europe ? beyond just the EPP trial.

    2. Wolgen?s final sentence in his letter mentions he looks forward to sharing the company success and newsflow soon. I read that as more good news is coming ? perhaps beyond just the EPP Phase III results. I get the impression from the tone of the letter that the company is in the beginning process of a quantum leap type of change.

    The share price is not a fair value share price right now. But the market has had so many delays with this, and there are other factors holding it down which are too lengthy to mention right now. But things look very promising at this time.

    However, the share price will not do much until they 1) release unequivocal good EPP results and/ or 2) there is some surprise such as another European country (such as Switzerland, the UK, Germany, etc.) follows suit with the Italians and says, ?Let?s cut the administrative and regulatory b.s. and allow EPP sufferers to get the drug now.?

    just my opinions and predictions
 
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