Cardiome -- CRME Message Board

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Biotech / Medical : Cardiome -- CRME

CRME 2.330

-2.1%

May 16 5:00 PM EST

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From: Ian@SI	2/20/2007 9:20:15 AM
	of 285

Target date for FDA decision... FDA agrees to review Cardiome heart drug Leonard Zehr The U.S. Food and Drug Administration has accepted for review a new drug application from Cardiome Pharma Corp. and co-development partner Astellas Pharma US Inc. for an intravenous formulation of RSD1235 to treat atrial fibrillation or irregular heartbeat in hospital emergency rooms. An FDA decision is expected in mid-October, reflecting a standard 10-month review period. Last May, the FDA refused to accept the filing, citing "inconsistencies and omissions" in the clinical data submitted by Astellas, which has marketing rights in North America for the IV drug. Vancouver-based Cardiome is developing RSD1235 as a pill without Astellas. COM (TSX) rose 76 cents to $14.20.

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