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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (83)	9/15/2006 8:37:11 AM
From: idos	Respond to of 285

CIBA with a positive view: September 13, 2006 CRME-NASDAQ (09/13/2006) $13.31 On 9/13, CRME reported full results of the ph.IIa trial of oral RSD1235, showing that the drug continued to have clear activity in reducing the recurrence of atrial fibrillation (a-fib), the key secondary endpoint. Very importantly, it appeared to be well tolerated in both dose groups. For the individual dose groups at 28 days, 61% of pts on 300mg 2x/day (33 of 54) remained in normal heart rhythm vs. 43% on placebo, which was statistically significant (p=0.048). 61% of pts on 600mg 2x/day (30 of 49) remained in normal heart rhythm, which nearly reached statistical significance (p=0.06). Had there not been slightly fewer pts in the higher dose group, we believe it would have reached statistical significance as well. When the dose groups were combined, there was again a clear demonstration of efficacy. At 28 days, a statistically significant 61% of pts (63 of 103) on oral RSD1235, either at 300mg 2x/day or 600mg 2x/day, remained in normal heart rhythm, compared to 43% of pts on placebo (p=0.028). Given that the study was not powered for efficacy, the fact that RSD1235 showed demonstrable, statistically significant efficacy in this relatively sick pt population is compelling, in our view. Oral RSD1235 continued to demonstrate a safety profile comparable to placebo, with no incidence of Torsades de Pointes arrhythmia. SAEs occurred in 8% of pts on placebo, 10% of pts on RSD1235 300mg 2x/day, and 11% of pts on 600mg. Potentially drug-related SAEs occurred in 1% of pts on placebo, 4% of pts on 300mg 2x/day, and 5% of pts on 600mg 2x/day. As in prior trials, asymptomatic bradycardia was the most common SAE, which we believe is not clinically meaningful. While there may be some confusion surrounding the dose response, we believe that overall, the final ph.IIa results are a clear win for CRME. We believe the data very strongly suggest that oral RSD1235 will be an efficacious and, important, safe, agent for the chronic prevention of a-fib. We believe the market potential for the drug in this indication exceeds $500M. Based on today's results, as well as our expectation that the NDA for IV RSD1235 will be accepted by year-end, we believe CRME shares will trade substantially higher by year-end. CRME remains a top small-cap pick.