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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 4:00 PM EDT
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To: Ian@SI who wrote (224)12/11/2007 5:16:49 PM
From: dr.praveen  Read Replies (2) of 285
 
FDA Experts Favor Caridome Heart Drug
Tuesday December 11, 4:50 pm ET
FDA Experts Back Approval Cardiome Pharma's Injectable Treatment for Irregular Heart Rhythms

<Hope it doesn't tank tomorrow Ian:-)>

WASHINGTON (AP) -- A panel of heart experts on Tuesday recommended U.S. approval for Cardio Pharma's injectable drug to stop irregular heart rhythms.

Outside advisers for the Food and Drug Administration voted 6 to 2 in favor of vernakalant, which showed positive results at treating patients experiencing atrial fibrillation, which causes the heart's upper chambers to contract randomly.

FDA is not required to follow the advice of its panels, though it usually does. It is scheduled to make a final decision on vernakalant by Jan. 19.

If the drug is approved, Japanese drug maker Astellas Pharma will have exclusive marketing rights in North America, under an agreement signed with Cardiome in 2003.

Vancouver, Canada-based Cardiome experienced volatile trading ahead of the FDA meeting. The company's stock fell last week on safety questions posed by FDA's safety review of the drug. However, shares rose significantly Monday when analysts said those concerns were probably overblown.

The company's shares were halted Tuesday ahead of the panel's vote.
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