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Biotech / Medical : SNRS- Sunrise Technologies

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Jun 6 11:01 AM EST

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To: BARRY ALLEN who wrote (3567)	12/28/1999 12:21:00 AM
From: Kevin Podsiadlik	Read Replies (1) of 4140

According to Donald R. Sanders, MD, PhD, of Elmhurst, Ill., an "unfortunate series of [events]" affected Sunrise Technologies' (Fremont, Calif.) laser thermokeratoplasty (LTK) data around phase 2-A of the company's clinical study, resulting in the decision on behalf of the Food and Drug Administration's (FDA's) Ophthalmic Devices Panel not to recommend the Hyperion LTK System for approval. Dr. Sanders said that although the originally used nomogram from the expanded phase 2A study produced no adverse readings or complications and resulted in good patient satisfaction, there was a tendency to undercorrect virtually all of the patients at 2 years post-treatment Reality check... Isn't the above contradicted by the testimony given in the transcripts on the July meeting? The panelists stated that their vote of not approvable was based on the inadequate quantity and timespan of the data presented, without even getting into the quality of the results reported. (You'd think something as basic as that would be gotten right.) Furthermore, any procedures done using any new "nomogram" based upon PDA data would have to be less than a year old. Given that long-term durability of the correction is a major issue, would the panel be likely to place much weight on data from operations with such a limited followup period?

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