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Biotech / Medical : Neopath (NPTH)
NPTH 0.0006000.0%Mar 7 3:00 PM EST
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To: pkwknk who wrote (50)9/30/1997 11:34:00 PM
From: John Zwiener   of 178
 
The data I used is from prior studies by npth and be cytc. Also there are studies by clinical labs that are considering the technology for use in their labs. Some of these labs(including university labs) have published in pathology newsjournals. I don't know what the FDA wants for it's endpoint to consider this instrument for approval as a primary screener, but the stuff I have read indicate that npth is better than human screeners.

How does one find out what the FDA wants as the endpoint for an instrument or drug. It must be public info. somewhere.
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