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Biotech / Medical : CVTX - CV Therapeutics, Inc.

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To: tom pope who wrote (303)5/15/2007 12:34:45 PM
From: mopgcw  Read Replies (1) of 411
 
mstar:
CV Therapeutics CVTX announced Monday that it has submitted regadenoson to the Food and Drug Administration for evaluation as a stress-testing drug for cardiovascular studies. Given regadenoson's good trial results, we have already factored in an FDA submission and plan to maintain our fair value estimate for CV Therapeutics. We currently assign a 70% chance of FDA approval for regadenoson. If the drug is approved, we would consider raising our fair value estimate by about $2 per share. Our thoughts on regadenoson are largely positive. Astellas Pharma, which currently markets Adenoscan, has agreed to market regadenoson because Adenoscan will go off patent in 2009. If regadenoson receives approval in 2008, it would have the advantage of a salesforce with established physician relationships. Furthermore, regadenoson will offer a better clinical profile and a more effective method of administration than Adenoscan.
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