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Re: New medications » djmmm

Posted by bob on February 4, 2002, at 16:04:49

In reply to New medications, posted by djmmm on February 4, 2002, at 13:45:15

Don't mean to be a wet blanket here, but I have a correction to your info; Cyberonics will not be getting FDA approval for their device this year. They announced disappointing results from their pivotal study where the response was not "statistically different" from placebo. They claim it was entirely due to a flawed study, and not to the device being ineffective. That are planning another pivotal study to prove their point. If this next study is a success, the approval would probably be sometime in 2004 - 2005.

 

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