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DewDiligence

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Re: DewDiligence post# 29962

Saturday, 06/10/2006 1:07:07 AM

Saturday, June 10, 2006 1:07:07 AM

Post# of 257264
More on CYBX…

http://boston.com/globe/business

>>
Problems put FDA under senator's scrutiny

June 8, 2006

Food and Drug Administration problems that have attracted the attention of Senator Charles E. Grassley and his investigators:

…Scientific integrity: A senior FDA staffer last year overruled more than 20 scientists who had spent 15 months reviewing the safety and effectiveness of the Vagus nerve stimulation therapy system, an implant to treat chronic depression . The reviewers said Cyberonics Inc., the device's maker, did not demonstrate a reasonable assurance of its safety and effectiveness for that use.
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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