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Non-Tech : Bill Wexler's Dog Pound -- Ignore unavailable to you. Want to Upgrade?


To: Dale Baker who wrote (2204)7/15/1999 6:21:00 PM
From: BelowTheCrowd  Respond to of 10293
 
Dale,

TheStreet.com summed up many of the issues today. Highlights include:

* The SNRS laser is less invasive than the VISX lasers, but work only for farsightedness.

* Even then, it is only up for approval on "mild farsightedness" which represents only a fraction of total laser surgery patients.

* A doctor wanting to treat most conditions would need a VISX-type excimer laser. A SNRS laser would have to complement the excimer laser, and would only be useful for a small number of patients.

* There is significant question about the long-term effectiveness of the treatment. It appears that many patients do not stabilize even after 18 months. The company has presented conflicting information on this.

* The standard of effectiveness is unclear. They are NOT measuring against 20/20 vision. Rather they are meauring the improvement in vision from the uncorrected state.

* Patients with "unrealistic expectations" were excluded from the reported data.

* Different protocols were used for phase II and III studies.

* The company data on its own website lists different numbers of patients studies on different slides. Not what you would expect from a well managed and accurately reported study.

* 9 of 11 clinical investigators own significant stakes in SNRS, ranging from 5,000 to 2.4 million (!) shares.

* Despite all this, FDA approval is possible. Their standards for devices are much lower than for drugs.

* Was brought public by Thomas James (now defunct due to SEC probe and fines for fraudulent sales practices).

* One Donald S. Chapman is a major investor. Last seen as a broker/promoter of PRST.

* They've had no success selling the lasers outside the US, but expect to sell lots of them in the US once FDA approval comes along.

So what you've got is a tool which is (at best) useful for only a small percentage of the population, which could only supplement (not replace) other tools, and about which there are still unresolved efficacy issues. It is being brought to market by a company of dubious origin.

The big questions are:

* Will the FDA approve?

* If they do, will the product sell?

My gut tells me that the answer to the first question is "yes" and the answer to the second question is "no." Kind of like ORG or CCSI.

And lots of thanks to TSC for bringing to light many items which I didn't notice up until now.

mg