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Biotech / Medical : Biotech Short Candidates
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To: mopgcw who wrote (600)10/30/2003 9:48:10 PM
From: mopgcw  Read Replies (1) of 897
 
KA-CHING. Nice call;

CV Therapeutics Shares Fall on U.S. FDA Letter About Ranexa
2003-10-30 18:17 (New York)

CV Therapeutics Shares Fall on U.S. FDA Letter About Ranexa

Oct. 30 (Bloomberg) -- CV Therapeutics Inc. shares fell as
much as 27 percent after the company said the U.S. Food and Drug
Administration may ask for additional research on Ranexa, an
experimental treatment for heart failure that would be the
company's first approved product.
The FDA sent CV Therapeutics a letter spelling out the steps
needed for Ranexa to win clearance. In the letter, the FDA said
that ``additional clinical information is needed for approval,''
the company said in a statement.
Earlier this month, the company said the agency had
scheduled a meeting with an FDA advisory panel about the Ranexa
application. The December meeting will focus on whether the
company has provided enough evidence of Ranexa's benefits, the
company said today. The panel's decision might affect the FDA's
position on approval, the company said.
Shares of the Palo Alto, California-based biotechnology
company fell as much as $6.02 to $16.50 in extended trading after
falling 94 cents to $22.52 as of 4 p.m., New York time, in Nasdaq
Stock Market composite trading. The announcement was made after
the close of U.S. markets.
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