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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST
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To: keokalani'nui who wrote (205)9/2/2007 10:46:38 PM
From: Biomaven   of 285
 
Issue with amiodarone is that it works very well, but comes with a whole lot of safety and tolerability baggage and so is something of a last resort. So they may not be able to show non-inferiority (because of Amio's good efficacy), and arguably they shouldn't have to if the drug is as safe as they claim. They may instead be able to get away with a placebo comparator.

I do agree design of an oral trial will be very tricky. But there's a big unmet need, so the incentive is certainly there.

Peter

(No position now or ever, but watching with much interest).
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