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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST

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To: tuck who wrote (265)8/11/2008 10:18:37 AM
From: former_pgs  Read Replies (1) of 285
 
>Prior to considering approval, FDA requires additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials in order to assure an acceptable risk benefit profile compared to electrical cardioversion. FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form, or dose level.<

The safety updates are routine, but the fact that the request in the first sentence is expressly separate from the request in the second sentence makes me think they will need some new data.

On a related matter, I've heard rumblings that the FDA is considering pulling water off the market...
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