To: Katz R Us who wrote (2331 ) 4/19/1999 9:47:00 PM From: Double E Read Replies (1) | Respond to of 4140
When I read the first one that has now been withdrawn, I thought it sounded a bit "aggressive" for where SNRS is in the review and approval process. It seemed a bit "out of character" for the SNRS management team. Below is the statement released later in the day by SNRS explaining what happened. This incident would have some interesting details if they were to be known. Someone will probably figure out what happened over the next few days and we will hear about it I'm sure. Here is the new statement: Monday April 19, 6:16 pm Eastern Time Company Press Release Sunrise Technologies International, Inc. Comments on News Release FREMONT, Calif.--(BW HealthWire)--April 19, 1999--Sunrise Technologies International, Inc. (Nasdaq:SNRS - news) said today that a press release issued in the company's name on April 19, 1999 at 9:07 a.m. EDT was unauthorized. The press release was issued by a source outside of the company and was not properly authorized or reviewed by the company. The company wishes to reiterate that its Sunrise LTK(TM) System for the treatment of hyperopia (+.75 to +2.50 diopters) is currently in clinical trials. On Feb. 1, 1999 the company announced that its premarket approval application (PMA) has been deemed suitable for filing by the FDA. The next milestone for the PMA will be a meeting with the U.S. Food and Drug Administration's (FDA) Ophthalmic Devices Panel, the timing of which is solely determined by the FDA. The Panel will meet and review Sunrise's application to determine whether to recommend that the file be approved by the FDA. Founded in 1987, the company produces and markets high technology products revolutionizing treatment methods in eye care. The company develops Holmium laser-based systems, which utilize a patented process for shrinking collagen developed by Dr. Bruce Sand (the ''Sand Process'') in correcting ophthalmic conditions. These Systems(1) incorporate a non-contact simultaneous application for correction of hyperopia (farsightedness), presbyopia (loss of focus due to natural aging), and overcorrection resulting from PRK and LASIK treatments for myopia. The system is currently in use in Europe and the Americas, and is in clinical trials in the United States. Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including market potential, regulatory clearances, business growth and other risks listed from time to time in the company's Securities and Exchange Commission (SEC) filings. These forward looking statements represent the company's judgment, as of the date of this release, and the company disclaims any intent or obligation to update these forward-looking statements. (1) Caution-Investigational Device: Federal law restricts this device to investigational use in the U.S. Internet users can access Sunrise's World Wide Web site at sunrise-tech.com . Someone was trying to put the cart before the horse with the earlier release. If you want to read it you can get to it on Raging Bull where someone saved it and posted it as it was written. GO SNRS! Double E