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

To: Sylvester who wrote (2916)	7/31/1999 6:18:00 PM
From: BARRY ALLEN	Read Replies (2) \| Respond to of 4140

The Wicked Witch of Oz....... >>>Summit was not the only manufacturer to receive a favorable review by the FDA. The Ophthalmic Device Advisors Panel also voted seven to one to recommend approval with conditions to VISX's PMA application. Marian Macsai, MD, was the lone member to vote against the application.<<< >>>As conditions were being hammered out, Dr. Macsai, the lone dissenter in the vote, continued to press the company about their data and patient follow-up. Dr. Macsai said, 'I don't mean to be the wicked witch of Oz. Bring me the broom. But I need more data. If you have it, we need to see it.' <<<< Ophthalmology Times, 11-06-1995, pp 8.

To: Sylvester who wrote (2916)	7/31/1999 6:36:00 PM
From: BARRY ALLEN	Respond to of 4140

Panel Recommendation: Not approvable since reasonable assurance has not been given that the device is effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling.(12 ayes, unanimous) *3. Follow-up of a minimum of 300 eyes out to 24 months, with 90% accountability;* **************************** PANEL RECOMMENDS APPROVAL OF NEW LASER TO CORRECT VISION BUT ADVISERS SAY FDA NEEDS MORE DATA BEFORE GIVING NOD ''LASIK can be more satisfactory to patients than PRK,'' today's eye laser surgery, said FDA adviser Woodford Van Meter of the University of Kentucky. ''It clearly is effective.'' But LASIK is a complicated procedure that depends heavily on the surgeon's skill, the FDA panel decided. The advisers said its developers at Emory University should give the panel more data, including proof that patients' vision stabilized properly six to 12 months after surgery and that side effects do not occur more often in eyes re-treated to further enhance vision. ''It's not a drive-through procedure,'' warned Dr. Marian Macsai, director of West Virginia's Medical Eye Bank. ''These conditions are not minor,'' added FDA eye chief Ralph Rosenthal. The FDA is not bound by decisions of advisory committees, but the agency usually follows them. Denver Rocky Mountain News, 07-12-1997, pp 56A. Now, why did the ODP hold SNRS to a higher standard??? That is the mother of all questions!