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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: Kevin Podsiadlik who wrote (3469)	12/1/1999 9:09:00 AM
From: Joe	Read Replies (1) \| Respond to of 4140

Kevin, I should have used single quotes. Here is the direct quote, "DR. MACSAI: Well, it's either 90 percent of the PMA cohort enrolled in Phase III clinical trials, or it's a number that provides you with an acceptable confidence interval, be it 300 or 400 or whatever, or 200. We have done it before, and I know that the FDA has provided us with this information to extract that number. DR. EYDELMAN: I now understand the sense of the panel...." Here Dr. Macsai was not talking about a guidance document, she was talking about the sample size needed to recommend approval. Her "... that provides you ..." was directed at the FDA representatives at the meeting. You point out that Dr. McCulley said 300 eyes, 90% at 24 months. This was only after considerable dialog between panel members coming up with these numbers. And your reference to the JULY meeting was actually a June 1998 meeting between FDA and Sunrise wherein FDA laid down the criteria for acceptance of the PMA. This was first mentioned by Dr. Koch in his presentation. Joe