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Biotech / Medical : Sepracor-Looks very promising
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To: kenhott who wrote (9029)11/21/2005 3:42:49 PM
From: Biomaven  Read Replies (2) of 10280
 
The trouble is that the trial would have to be very large because the event rate is so low. The FDA warning was based on a 26k patient trial lasting 28 weeks. The long-acting drug salmeterol had 13 deaths vs. 3 deaths with placebo (both given on top of usual therapy).

Further, you couldn't blind the trial because arformoterol is only available as a neb. May not matter if you take death as the endpoint, but would be a problem for efficacy endpoints.

Peter
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