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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: kenhott who wrote (64)	8/31/2006 9:48:57 PM
From: dr.praveen	Respond to of 285

From Yahoo... Some of the things discussed during that call about oral RSD1235 are as follows. - Due to the "unexpectedly strong results" (the words in quotes are the exact words used by Bob Reider, the CEO) that were seen in the low dose (300 mg) group in the interim analysis of the current phase 2a study, management may consider going directly to a phase II/III study that is more regulatory in nature instead of doing further dose ranging via a phase 2b study. However, they first want to see the results from the high dose (600 mg) group of the current phase 2a dose range study in order to analyze the dose response curve with the two doses before proceeding in the direction of a phase II/III study. - They are now working on a 1x daily formulation for oral RSD1235 that may be used as early as the second phase 3 study or else will be introduced as a post approval enhancement (the current 2x daily formulation is performing well and management is comfortable with using that formulation for the phase 3 studies and initial marketing). - Based on the phase 3 work recently done by Sanofi with oral dronedarone, management expects that phase 3 studies for oral RSD1235 will require about 1500 patients exposed to drug with study lengths of around 12 months.