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CV Therapeutics (ticker: CVTX, exchange: NASDAQ) News Release - December 9, 2003 -------------------------------------------------------------------------------- FDA Advisory Committee Evaluates Ranexa(TM) PALO ALTO, Calif., Dec. 9 /PRNewswire-FirstCall/ -- The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) today discussed a range of issues relating to the review of Ranexa for the treatment of chronic angina, but did not vote on any matters presented to it. "We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics (Nasdaq: CVTX). None of CV Therapeutics` products, including Ranexa, have been approved for marketing by the FDA or other foreign regulatory agencies. On October 30, the FDA sent CV Therapeutics, Inc. an approvable letter indicating that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics` products have not been determined to be safe or effective in humans for any uses. Company management will webcast a conference call on Tuesday, December 9 at 6:30 p.m. EST, 3:30 p.m. PST on the Company`s website to discuss this announcement. To access the live webcast, please log on to the Company`s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through Tuesday, December 16, 2003. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 4420762. If approved, Ranexa would represent the first new class |
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| aus der Diskussion: | +++ CV Therapeutics Inc (CVTX) - Kurssturz +++ |
| Autor (Datum des Eintrages): | Isabartels (10.12.03 14:45:33) |
| Beitrag: | 79 von 470 (ID:11567151) |
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