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Biotech / Medical : SNRS- Sunrise Technologies

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Jun 6 11:01 AM EST

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To: majormember who wrote (198)	11/15/1997 2:54:00 PM
From: EmuGreg	of 4140

Skane, this is just a suggestion, but I think that I would use the opportunity to focus on how the PMA (Pre-Market Approval) times are being affected by: 1) the re-engineering being done by the FDA and 2) the new legislation to make the FDA more effecient. You might look at the annual report under the CDRH section on the FDA website prior to your visit. It discusses how PMA times in 1997 have been shortened dramatically. Sunrise has not yet filed for its PMA. This application is made after Phase III is completed. Hence, your contact would presumably not have an application in front of her yet. One thing you might run by her is whether she thinks that the Sunrise/LTK process would have to go in front of the opthalmic committee and what the criteria is for by-passing that committee. My understanding is that established technolgy does not always go in front of the committee. Since YAG lasers are well known, I've wondered if the laser itself has enough of a prior history to leverage off of and avoid going through the committee. Best of luck to you. Greg

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