To: Anthony@Pacific who wrote (3725 ) 1/14/2000 4:15:00 PM From: Anthony@Pacific Read Replies (1) | Respond to of 4140
SNRS<---------------SLAMMED ..smelly stinky approval!1 Sunrise's first attempt at FDA panel approval was rejected in July. At the time, the panel said the company needed more long-term data and that patients lost some of the vision correction that the procedure provided. Originally, Sunrise asked the Food and Drug Administration to approve the laser procedure for "correcting" mild-to-moderate hyperopia, the medical term for farsightedness. The company changed that request to "reducing" mild-to-moderate hyperopia, "where the magnitude of correction diminishes over time." "The FDA held their noses and approved this," said Stephen Sabba, an analyst at Sturza's Medical Research. Sabba said that Sunrise's laser system only reduces low hyperopia instead of mild-to-moderate hyperopia, and that the product is going to be a "hard sell." Leza of Graig-Hallum agreed, saying that the "temporary" label recommended by the FDA panel may repel some potential customers. laser's label. The term should be thoroughly defined in patient handouts. "That was the price of being approved," Sabba said. But Ed Coghlan of Sunrise disagreed. "The company received good news, as did the field and ... hyperopia patients," Coghlan said. "All hyperopia (procedures) have a change and effect," he said. Coghlan said Sunrise's 2.8 second laser system procedure is faster and safer than other laser system. "We are looking to be the next Sunrise," responded Coghlan to analysts' statements that investors are viewing Sunrise as the next Visx. Coghlan said unlike other laser technologies, its Hyperion product is designed exclusively for the treatment of hyperopia. Coghlan said the company expects the launch of its laser system in the U.S. to produce earnings. "We expect sales to begin once we get FDA approval," he said. Sunrise reported a net loss of $5.78 million, or 13 cents a share on revenue of $6,000 for the third quarter ended Sept. 30. LOLOLOLOLOLOLOOLOLO!!!!!!!!!!!!!!!!!!!!!!!!!!!!! 6K in sales..EUROPE MUST BE BROKE!!!!!!!!!