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Biotech / Medical : BEAM, BOL, KERA, LASE, LCAV, LVCI, LZRC, VISX, SNRS, STAA
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To: HerbVic who wrote ()8/14/1999 2:14:00 PM
From: HerbVic   of 253
 
Ticker: SNRS
Form: 10-Q
Filing Date: 8/13/99

<excerpt>
The Company has developed to date a large amount of clinical data on the
safety and efficacy of the LTK System in correcting hyperopia and it continues
to develop additional data on the long-term safety and efficacy. The FDA has not
yet determined whether the LTK System will prove to be safe or effective for the
predictable and reliable treatment of hyperopia or other common vision problems.
|| There can be no assurance that long-term safety and efficacy data, when
|| collected, will be consistent with the clinical trial results previously
|| obtained or will demonstrate that the LTK System can be used safely and
|| successfully to treat hyperopia in a broad segment of the population on a
|| long-term basis.

The PMA for the LTK System was filed with the FDA in December 1998. We
appeared before the Ophthalmic Devices Panel ("Panel"), an advisory committee of
the FDA, on July 22, 1999 to present the results of our clinical trial for the
correction of hyperopia from +0.75 to +2.50 diopters. The Panel requested
additional long-term data and did not make a recommendation for approval at that
time. While we are disappointed with the Panel's recommendation, we are working
with the FDA staff to determine what information and additional data are needed
to advance the regulatory review.
freeedgar.com

|| And therein lies the rub... with the controversy over clinical investigator investors, and the precarious financials of this company, the market will remain skeptical. Even with FDA approval, there is still much to do in terms of marketing. SNRS has a long way to go.

My money's on BEAM at this point.
HerbVic
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