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

To: DELT1970 who wrote (2809)	7/23/1999 12:03:00 PM
From: Bruce L	Read Replies (1) \| Respond to of 4140

This mornings SNRS CC I only heard a portion of, but here's the essence that I picked up: l. The company believes the panel did not follow the guidelines for medical devices and will seek to overturn the decision with the FDA. 2. There is at least one precedent where the FDA, in the case of an adverse recommendation by its panel, reversed that panel. In 1989! 3. The issue that killed SNRS was "fade." However, this same issue (fade over time) was present in the case of VISX and other laser device makers. And it was present to the same degree with the same uncertainty as to whether the positive effects of the laser surgery would disappear over time. Yet VISX's device was approved. This is unfair and SNRS will pursue this with the FDA. 4. SNRS will attempt to work informally with the FDA, i.e., in private consultations. The company believes this kind of approach is feasible and that it is conceivable that some compromise could occur in the "near" future. 5. If the company is required to present new data on the issue of fade, this can be submitted in the proper format as soon as the end of the year. These were the impressions I came away with. If any one wants to make some corrections or additions, please do so.