To: Anthony@Pacific who wrote (46780 ) 11/24/1999 12:15:00 PM From: Hockeyfan Read Replies (1) | Respond to of 122088
Sunrise Shares Rise After FDA Grants 2nd Panel Review (Update2) Bloomberg article casts doubt on SNRS chances of success.quote.bloomberg.com Excerpt... The panel said the company didn't provide enough data showing the effect of the laser didn't wear off over time. The company still faces an uphill battle to change panel members' minds, an analyst said.``Best-case scenario for the company: It receives approval for the temporary correction of hyperopia,' said Richard Leza, an analyst at Craig-Hallum Capital Group. ``And I can't see this happening because this means a patient would need to go back to be re-treated every two years.' The company said it had compiled additional data from the trials it presented in July, and would use the meeting to address ``earlier concerns regarding the change in refractive effect over time.' One panel member, Michael Grimmett of the University of Miami, presented an analysis of the company's data to the panel in July. ``Since it can be reasonably construed that the average patient will want more than a temporary refractive effect, it is my firm opinion the (laser) is not approvable,' he said at the meeting. At that time, the panel said it would like to see two-year results of 300 surgeries. Sunrise presented 18-month results of 144 surgeries at the meeting. **** If Sunrise presented 18-month results of 144 surgeries at the July meeting, they can now present two-year results for 144 surgeries. How are they going to get the two-year data on the additional 156 surgeries needed to reach 300? If they come up with this data, how are they going to explain why they didn't include the 156 additional patients in the original group?