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Non-Tech : Auric Goldfinger's Short List
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To: Sir Auric Goldfinger who wrote (3677)10/22/1999 9:41:00 AM
From: majormember  Read Replies (1) of 19428
 
Hope you covered your SNRS short....
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Sunrise Technologies International, Inc. Expects to Return to FDA Panel First Quarter 2000

FREMONT, Calif.--(BW Healthwire)--Oct. 22, 1999--Sunrise Technologies International, Inc. (Nasdaq/NMS:SNRS) today announced it expects its pre-market approval ("PMA") application to be considered by the Ophthalmic Devices Advisory Panel ("ODP") of the United States Food and Drug Administration ("FDA") in the first quarter of 2000. As a result, the Company is preparing an amendment to its PMA application for the reduction of hyperopia within the range of +0.75 to +2.5 diopters.

Since the Company's first appearance before the ODP on July 22, 1999, Sunrise has had very productive meetings with the FDA Ophthalmic Devices Branch to review its PMA submission. The Company's PMA amendment contains a substantial increase in the number of patients followed through two years compared to that presented at the July panel meeting. As a result of discussions with the FDA staff, the Company's amended PMA will quantify and explain the postoperative outcome that LTK patients may experience, thereby addressing earlier concerns regarding change in refractive effect over time.

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