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The information that you have been posting regarding Cephalon is both disillusioning as well as deceptive. The posting of Cephalon's SEC filing statement by you is, no doubt, intimidating to those who do not know or understand the true purpose of such a filing statement. If one were to view the SEC statements filed by Intel (I use them as an example because they are viewed as a strong profitable company by most people)they would be astounded by some of the comments. Intel states that they should continue to do well BUT if the chip market changes and computers no longer need their type of chip etc. etc then Intel's profits could severely decline. You see, there is something called the Safe Harbor Act which prohibits a company from speaking very positively about their company. The SEC filing is written much the same way by all drug companies when an NDA is filed. Actually, a lot has happened since the 1995 Advisory Committee hearing. At the actual hearing, 4 panel members, including the head of the panel, indicated they would like a third Phase III trial done because the European trial data did not show efficacy of Myotrophin. Indeed, more people died taking Myotrophin than not! Cephalon went on to show that the reason for this was that the ALS patients that died were already very "near death" and there were more "near death" patients in the Myotrophin group than in the placebo group. Now, in post-hoc analysis it has been made clear that there is no fatal effect of Myotrophin and, as a matter of fact, there is actual a survival increase in the European trials that are continuing. In other words, the only concern which the FDA had is now erased. I have actual figures and results of this post hoc analysis. If you would like me to post them, I will. There is a more important point here. I personally know an ALS patient who is taking Myotrophin. It works. This person could not even wash dishes. Now she goes up and down the stairs, washes dishes, and can actually laugh. The FDA knows this. You may want to hoot and holler that Myotrophin doesn't work just because you shorted the stock. It is not ethical. There is a lot more I can post, but I am quite busy right now. Harkenman, if you want to knock Cephalon that is fine. But back it up. Rilutek had far less compelling data and was approved. It, however has far too many side effects and really does not work that well. This was known when it was approved. Myotrophin, in combination with Rilutek, may be a new cocktail but this is something that will need to be tried. The FDA is not going to overlook that. In addition, Cephalon has quite a strong pipeline and $147 million in cash. Sure, the FDA could turn down Myotrophin (after all, O.J. was acquitted, right?)but the FDA has considerable pressure from Congress as well as strong lobbying ALS groups. I have many indepth posts on the Motley Fool message boards. Read them. Good Luck. |
