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gilamonsterz

08/01/14 12:01 PM

#1262 RE: PJO #1261

They didn't satisfy the requirements for an actual study. My undestanding is that they tried to compare results from two existing studies, and the pannel wouldn't accept that.

edit - because I'm bad at explaining things:

" Enrollment issues associated with the pivotal trial for the Ablatherm device forced the sponsor to make use of a post-hoc analysis assembled prior to completion of the trial, but the panelists largely brushed aside what some said was a reasonable safety record in an 8-0 vote that the benefits do not outweigh the risks. "

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=MDD_Alert07302014d