As you can see, and early indicator was:
Message 19136353
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.
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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.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 20 years.
Company management will webcast a conference call to discuss this announcement on Monday, August 4, at 8:30 a.m. EDT, 5:30 a.m. PDT, on the company's website. |
