CVTX - CV Therapeutics, Inc. Message Board

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Biotech / Medical : CVTX - CV Therapeutics, Inc.

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From: tom pope	3/7/2007 1:21:00 PM
	of 411

Why my wife sometimes think I'm as thick as four planks - at first read I thought the label was to be issued in one hour and 8 minutes. Oh well, never mind. Merrill (neutral): MERLIN missed primary endpoint but Ranexa safe: CVTX reported top-line results from MERLIN yesterday afternoon. As we expected (detailed in our note on January 25th “Will MERLIN work? Upside/downside scenarios”), MERLIN failed to achieve the primary efficacy endpoint but “there was no adverse trend in death or arrhythmias.” Please see text from press release on page 3. What will label say? The company believes that “the data could support expansion of the existing Ranexa indication to include first line angina” per the special protocol agreement (SPA) with the FDA. However, FDA does not always abide by SPAs, so we would wait to see the final label, which the company suggested could be issued in 1H:08. We would watch script trends and expenses: The bulls expect this safety data to accelerate script growth, but we conservatively model ongoing, consistent TRx growth and maintain peak US sales of $240M in 2012E. We think the company could expand sales and marketing efforts and/or look to partner Ranexa (which would help offset costs). We are maintaining our SG&A projections at this time as we await further company communications. Please see our detailed models on pages 3–6. Full data presentation at ACC and analyst meeting in PM: The full data will be presented at ACC (American College of Cardiology) on Tuesday, March 27th, at 8:50 AM CST. The company told us it will hold an analyst meeting in the afternoon after the data presentation.

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