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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: HeyRainier who wrote (2728)	7/21/1999 7:41:00 AM
From: BostonView	Read Replies (1) \| Respond to of 4140

With this, the shorts have played their last card. Now, let's hope the FDA trumps them good. BV

To: HeyRainier who wrote (2728)	7/21/1999 3:59:00 PM
From: Sir Auric Goldfinger	Read Replies (3) \| Respond to of 4140

ANYONE went into tommorows's halt long is TOAST! "Clinical Investigators Who Tested Sunrise Product Held Its Shares By DANIELLE SESSA Staff Reporter of THE WALL STREET JOURNAL Sunrise Technologies International Inc. will go before a U.S. Food and Drug Administration advisory panel Thursday, hoping to get a step closer to having its laser treatment for farsightedness approved. The company will present evidence from clinical trials. But one thing the members of the panel won't necessarily hear is that at least seven of the 11 clinical investigators who performed the trials of the vision-correction system own stock in the Fremont, Calif., company. In fact, the clinical investigators own more stock than the nine top-level executives, or so-called insiders, combined. Although FDA rules require companies applying for premarket approval to disclose the financial interests of the clinical investigators, the rule went into effect in February, two months after Sunrise submitted its application. Two of the investigators, David Brown and Alan Aker, owned a combined 4.11 million shares, or 9.7% of the shares outstanding, currently worth nearly $70 million, according to a form S-3 filed with the U.S. Securities and Exchange Commission on June 16. The nine insiders, in contrast, owned just 1.28 million, or 3% of the shares outstanding of Sunrise, according to the company's April 7 proxy. Sunrise acknowledges that some of the 11 clinical investigators have financial interests in the company that would have required disclosure, the company said in the June SEC filing. The company went on to say in the filing: "It is not possible to predict, however, what impact, if any, the disclosure of these interests would have on the FDA's review of the PMA we submitted for the LTK system." Approval for U.S. Sales The company needs approval from the FDA for its laser thermal keratoplasty, or LTK, treatment before it can sell the system in the U.S. LTK has already received European marketing approval. Russ Trenary, president and chief executive officer of Sunrise, said the trials were conducted by investigators "who owned no stock in the company and people who did own stock." Dr. Brown added that the research is all in "very scientific" terms and the FDA is very careful to monitor the data so there's "no way for anyone to go out and make up stuff." The clinical investigators received some stock through several private placements of promissory notes with warrants and stock offerings since 1997, according to SEC filings. On Dec. 4, 1998, the company announced it completed a $11.8 million private placement of stock where the shares were offered at $3.50 a share, nearly 40% less than where the stock finished trading that day. Mr. Trenary said that the shares were offered at a discount because the company was saving money by not using an investment banker for the offering and that the company wanted it to be an easy decision for the doctors to buy stock. He added that the stock was offered at a 20% discount at the time. Investors who acquire stock through private placements can register the stock when the company files an S-3. Once the stock is registered it can be sold on the open market; however the sales don't have to occur right away, nor do the investors have to sell them at all. Mr. Trenary said that he hasn't sold the shares that he registered in the June filing and Drs. Brown and Aker haven't indicated to him that they sold their shares either. Timing of Aker's Purchases Dr. Aker, an ophthalmologist, said he started buying shares of Sunrise through private placements before he became a clinical investigator for the company three years ago. "You basically have to be convinced that the technology works" to invest in a company through a private placement, Dr. Aker said. "If I had doubts about the technology I would have never invested in the company." Asked about his large stake in the company, Dr. Brown said: "One of the things about my job is to be up on everything that is new and exciting in our profession. I tend to like to pick up companies that are in the early stages of development and have promise." Shares of Sunrise have been soaring in anticipation of positive results from this week's meeting. The stock has more than doubled on the Nasdaq Stock Market since the start of the year. Shares of Sunrise fell 87.5 cents, or 4.9%, to $17 apiece Tuesday. Sunrise has also been a hot target among short sellers, who sell borrowed shares in hopes of replacing them later at a lower cost, and thereby pocketing the difference. Short interest in Sunrise has risen 35% to 4,369,160 shares in mid-June from 3,227,585 shares in May.