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Biotech / Medical : biotech binary events

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To: dalroi who started this subject	10/15/2003 12:05:15 PM
From: rkrw	Read Replies (3) of 295

10/30 PDUFA. What do you guys think? Will the fda decide or ask for more time? Deadline is closing in. Press Release Source: CV Therapeutics CV Therapeutics and FDA Agree to Cancel September Ranexa(TM) Advisory Committee Meeting Friday August 1, 10:06 pm ET PALO ALTO, Calif., Aug. 1 /PRNewswire-FirstCall/ -- CV Therapeutics (Nasdaq: CVTX - News) announced that it had reached agreement today with the U.S. Food and Drug Administration (FDA) to cancel the review of Ranexa(TM) (ranolazine) by the Cardiovascular and Renal Drugs Advisory Committee in September 2003. ADVERTISEMENT CV Therapeutics and the FDA agreed that a September advisory committee meeting, which would have required a mid-August distribution of briefing packages to advisory committee members, would not have provided sufficient time for CVT and the FDA to complete ongoing discussions, communications and analyses of the Ranexa NDA. CV Therapeutics submitted a new drug application (NDA) for Ranexa to the FDA on December 30, 2002. Under the Prescription Drug User Fee Act III, the action date for the Ranexa NDA is October 30, 2003.

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