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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?


To: kenhott who wrote (9029)11/21/2005 3:42:49 PM
From: Biomaven  Read Replies (2) | Respond to 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