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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: BigKNY3 who wrote (18979)2/22/1999 10:51:00 PM
From: VLAD  Read Replies (2) of 23519
 
Medical Officer's remark on the issue of being pressured by supervisors included the following:

"My office director told me that he was going to overrule me because the sponsor (Wyeth-Ayerst) would just go over our heads to Capitol Hill. He felt it was best to approve the drug for an indication not studied and have sponsors do a phase IV post marketing trial in support of the indication. I reminded him that the sponsor had failed to honor other Phase IVs. He went ahead and approved the drug."

"Our supervisors didn't put pressure on us. They just ignore our opinion and write their own memo."
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