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


To: BARRY ALLEN who wrote (2966)8/7/1999 11:48:00 PM
From: BARRY ALLEN  Read Replies (1) | Respond to of 4140
 
SNRS was railroaded!

Dr. Koch said that data for the 90 eyes with 18 months of follow-up indicated that LTK visual acuity results were stable.

Dr. Stulting told the panel that the United States is years behind the rest of the world in treating refractive errors, and that international ophthalmologists cannot understand why the FDA would not approve a technology that has been used around the world with good results.

The panel then voted unanimously not to recommend the Hyperion for approval. They cited the lack of cycloplegic refraction data, the need to account for at least 90% of patients at the 24-month follow-up period, the problem with including the first 50 cases in the study, the need for an updated patient questionnaire and the lack of a data breakdown by gender.

"At further follow-up, we will be able to approve safety and efficacy," Dr. Macsai said, among the concluding remarks.


The Wicked Witch of Oz makes a bold prediction!
exchange2000.com