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

To: IRWIN JAMES FRANKEL who wrote (2461)	1/5/2001 10:39:53 AM
From: Biomaven	Read Replies (3) \| Respond to of 52153

I just added to my CVTX. I think the market is totally misinterpreting this release - it implies nothing at all about the likelihood of success of the trial. Note that there was no penalty for this "early look" at the data because they didn't break the blind - all they did is looked at the variability of the combined data (both drug and placebo). Headline: CV Therapeutics Updates CARISA Trial Enrollment ================================================================ /FROM PR NEWSWIRE SAN FRANCISCO 415-543-7800/ [STK] CVTX [IN] BIO MTC [SU] TO BUSINESS AND MEDICAL EDITORS: CV Therapeutics Updates CARISA Trial Enrollment PALO ALTO, Calif., Jan. 5 /PRNewswire/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) today announced that it has completed enrollment of the originally planned 462 patients in the Phase III CARISA (Combination Assessment of Ranolazine In Stable Angina) trial, but plans to enroll an additional 186 patients based on a blinded interim assessment. The just-completed CARISA interim assessment was performed in order to minimize the risk of a false negative study. The interim evaluated the statistical variance of the primary endpoint, treadmill times, but did not assess the efficacy of ranolazine compared to placebo. Based on the variability in treadmill times, the protocol-specified interim assessment dictated enrollment of an additional 186 patients. With the current enrollment rate, the Company anticipates completing enrollment of the additional patients by the second quarter of 2001. The CARISA trial is designed to examine the effectiveness of ranolazine in combination with other anti-anginal medications. Ranolazine is an investigational drug candidate in a new class of drugs known as pFOX (partial Fatty Acid Oxidation) inhibitors. "We are pleased with the current strong enrollment rate in the CARISA trial, our trial design and our completion of enrollment of the originally specified patients according to our timetable," said Louis G. Lange, M.D., Ph.D., Chairman and Chief Executive Officer of CV Therapeutics. "The interim variability assessment provides us with an opportunity, prior to unblinding the trial and without a statistical penalty, to support the power of the trial by enrolling additional patients." Peter