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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST
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To: Ian@SI who wrote (155)5/24/2007 3:36:38 PM
From: dr.praveen  Read Replies (2) of 285
 
Hi Ian,

From the report:

In our view, all remains on track at Cardiome,including recruitment into the Phase 2b oral trial. Furthermore, we remind investors of the stock’s potential inflexion points in 2007:
· ACT-2 results of IV vernakalant in heart surgery patients in late Q2;
· Decision on Artesian compound (go / no-go) in late Q2;
· IV vernakalant PDUFA date is 19 October 2007;
· IV vernakalant to be partnered in Europe in Q3 or Q4;
· Oral vernakalant Phase 2b interim data is due in Q4/07; and
· IV vernakalant to be filed in Europe by year end.

Cardiome is currently working on the assumption that an Advisory Panel will be required for IV vernakalant. We will not read much either way into an FDA panel requirement, but note that the next CardioRenal panel is due to meet on 21 August; with 11 weeks notice available to sponsors,this would suggest that Cardiome should be notified by mid June.
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