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Biotech / Medical : CVTX - CV Therapeutics, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (317)	9/28/2007 2:55:35 PM
From: mopgcw	Respond to of 411

mstar: CVTX announced Thursday that it has submitted its flagship drug, Ranexa, for a label expansion to include first-line treatment of chronic angina. We are leaving our fair value estimate unchanged as we had already anticipated the Food and Drug Administration submission. Although we think the FDA will approve Ranexa for first-line treatment, we still anticipate the majority of future sales to come from second-line use. Thanks to Ranexa's relatively poor safety profile and the efficacy of generic angina drugs, we think doctors will only prescribe Ranexa under certain conditions, such as when angina patients don't respond well to beta-blockers and nitrates. We think a first-line label expansion and Ranexa's good Phase III safety data should reassure doctors who already considered prescribing the drug as a second-line treatment.

To: keokalani'nui who wrote (317)	12/18/2007 4:32:32 PM
From: tuck	Read Replies (1) \| Respond to of 411

>> FDA Approves New Mechanism of Action Labeling for Ranexa(R) Tuesday December 18, 4:10 pm ET PALO ALTO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that the U.S. Food and Drug Administration (FDA) has approved new language for the product labeling for Ranexa® (ranolazine extended-release tablets) which describes the ability of ranolazine to inhibit the late sodium current at therapeutic levels. Published data on ranolazine's mechanism suggests that during ischemic episodes excess sodium can flow into cardiac cells through sodium channels. This excess sodium can trigger a subsequent overload of calcium that can lead to problems with proper contraction and relaxation of the heart. Late sodium current inhibition has been shown to improve mechanical and electrical dysfunctions of cardiac cells under these circumstances. "We believe it is important for physicians to have as much information as possible on the mechanism of action for Ranexa and we are very pleased that the FDA has worked with us to add this new language to the approved product labeling," said Louis G. Lange, CV Therapeutics chairman and chief executive officer. Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. Complete product labeling is available at www.cvt.com. << snip So far, good for 5 - 10% after hours -- trading looks erratic. Might have room to run? I'm thinking there was more than ~$30 million worth of uncertainty about this in the market cap. Cheers, Tuck