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Biotech / Medical : Biotech Valuation

CRSP 53.61

-1.8%

11:06 AM EST

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From: Ian@SI	7/7/2006 1:05:00 PM
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With all the weasel wording, I'd expect new trials will be required... 11:17AM Cardiome Pharma announces they are "pleased with how the meeting went with the FDA" (CRME) 8.75 -0.11 : Co announces that representatives from its co-development partner Astellas Pharma and Cardiome have met with the FDA to discuss the "refusal to file" letter received on May 30, 2006 for the New Drug Application for RSD1235, an investigational new drug for the acute conversion of atrial fibrillation. The meeting was requested by Astellas and Cardiome in order to explore the issues referenced by the FDA within the R.T.F letter, and to discuss appropriate measures which can be taken to resolve those issues. The amended NDA will be re-submitted following completion of this process. "We are pleased with how the meeting went with the FDA," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "Astellas and Cardiome will reflect on the discussion and, following consultation with their partner, expect to be in a position to provide further guidance to investors in the near term regarding the timely and accurate re-submission of the N.D.A for RSD1235.

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