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Biotech / Medical : Neopath (NPTH)

NPTH 0.000600

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Mar 7 3:00 PM EST

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To: Vern R. Starks who wrote (168)	4/12/1999 10:57:00 AM
From: Volsi Mimir	Read Replies (1) of 178

CYTC didnt get approval of their's: biz.yahoo.com Cytyc Learns that the FDA has Denied All Petitions to Review Approval of ThinPrep(R) Pap Test(TM) BOXBOROUGH, Mass., April 8 /PRNewswire/ -- Cytyc Corporation (Nasdaq: CYTC - news) today announced that the U.S. Food and Drug Administration (FDA) has ruled on seven petitions objecting to the approval of the ThinPrep® Pap Test(TM). In a letter addressed to petitioners, and copied to Cytyc, the FDA concluded: ''It would serve no useful purpose to convene an advisory committee of experts to consider the objections raised in the petitions.'' The FDA methodically and thoroughly addressed each of a total of 10 objections raised by the seven petitioners. In each instance, the agency provided a detailed response and concluded that there was no justification for review. ''I am obviously pleased but not surprised by the FDA's conclusions,'' said Patrick J. Sullivan, Cytyc's president and chief executive officer. ''We have never doubted the scientific validity of the clinical trial data submitted to the FDA. The outstanding performance of the ThinPrep Pap Test continues to be validated by published studies that have consistently demonstrated the improved efficacy of the ThinPrep Pap Test in routine clinical use in laboratories worldwide.'' ''It is unfortunate that the FDA was unnecessarily burdened with what we always believed were petitions driven more by competitive commercial interests rather than in the interest of science,'' Sullivan concluded. [nothing like biting the hand that feeds you]

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