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Biotech / Medical : biotech binary events -- Ignore unavailable to you. Want to Upgrade?

To: kenhott who wrote (255)	4/19/2007 4:18:59 PM
From: tuck	Read Replies (1) \| Respond to of 295

>>Neurochem Stock Down After Alzhemed Trial Update >NRMX Last update: 4/19/2007 1:28:44 PM By Andy Georgiades Of DOW JONES NEWSWIRES TORONTO (Dow Jones)--Shares of Neurochem Inc. (NRMX) tumbled Thursday after the Quebec-based biotech announced changes to the statistical model used to evaluate a pivotal trial of its Alzheimer's Disease drug, Alzhemed. As reported, the database for the North American Phase III trial of Alzhemed has been locked. However, the company's external team of statisticians has advised the company that, to provide accurate results, adjustments to the initial statistical model are "necessary." It noted that "potential refinement" of the statistical model was previously discussed with the U.S. Food and Drug Administration. "The procedure to arrive at a reliable model involves a detailed analysis of potential confounding factors such as the effect of concomitant medications, baseline characteristics of the study population or differences in clincial sites," Neurochem said in a release. Results are still expected by the end of June. On Nasdaq Thursday, Neurochem is down $1.09, or 8.7%, to $11.40 on about 516,000 shares. It traded as low as $11.18 earlier in the session. "This does not sound good," said one fund manager who is familiar with Neurochem but doesn't own the stock. The fund manager added that the company's announcement highlights the complexities of drug testing in Alzheimer's Disease, a condition that remains something of a mystery to the scientific community. In addition, because some patients deteriorate faster than others, it can create difficulties comparing the drug group to the placebo group. Neurochem announced in January that it completed the 18-month trial, which involved 1,052 patients at 67 clinical sites in the U.S. and Canada. A primary endpoint is the evaluation of cognitive abilities. If efficacy is established, magnetic resonance imaging, or MRI, would then measure brain volume change from baseline. In a research report, Cormark Securities analyst David Dean maintained his bearish stance, saying in a note that, if the drug met its primary endpoint, the news out of Neurochem Thursday might have been different. "While this is a large and complex trial, the endpoint is not. It either meets the primary for the entire population, or it does not," he wrote. "We expect that the role of the various confounding factors would be captured by the placebo group, not by modified statistical protocols. We believe that the FDA will have a similar view to ours." Neurochem's stock is down about 47% since the start of the year. The most recent hit came last week, when the company said the FDA needs another three months to evaluate its new drug application for Kiacta, a potential treatment for AA amyloidosis, a common cause of kidney disease. Company officials weren't immediately available to comment. Company Web Site: neurochem.com -Andy Georgiades, Dow Jones Newswires; 416-306-2031; andy.georgiades@dowjones.com (END) Dow Jones Newswires April 19, 2007 13:28 ET (17:28 GMT)<< A few months ago I tried to leg into a bear spread on NRMX. The short puts filled first, then the stock flapped around a bit without my long put order getting filled. I bailed for a small profit on the short puts, and am very glad I did. Cheers, Tuck