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Biotech / Medical : Gliatech (GLIA) -- Ignore unavailable to you. Want to Upgrade?

To: PHILLIP FLOTOW who wrote (1174)	1/12/2000 4:19:00 PM
From: PHILLIP FLOTOW	Read Replies (1) \| Respond to of 2001

Headlines only: 01/12 4:11P (DJ) +DJ Gliatech Pres, Oper Chief John Redmond Resigns >GLIA Story 5098 +DJ Gliatech Chmn, CEO Oesterling To Assume Pres Duties Story 5102 +DJ Gliatech To Search For New Pres To Replace Redmond >GLIA PHIL

To: PHILLIP FLOTOW who wrote (1174)	1/13/2000 12:48:00 AM
From: sim1	Read Replies (1) \| Respond to of 2001

More on FDA/LCBM rejection... Wednesday January 12, 7:17 pm Eastern Time FDA panel rejects LifeCore surgical solution ROCKVILLE, Md., Jan 12 (Reuters) - Medical device maker LifeCore Biomedical Inc.(NasdaqNM:LCBM - news) failed to clear a key hurdle Wednesday in its bid to sell its surgical adhesion product in the United States. A Food and Drug Administration advisory panel voted 5 to 2 to recommend that the FDA turn down LifeCore's application to market Intergel Solution in the United States. Panel members said they were not convinced that LifeCore's studies showed Intergel, designed to reduce internal scarring after gynecological surgery, provided a meaningful benefit. "From a clinical standpoint, I think we're hard pressed to say this device makes a difference," said panel member Dr. Barbara Levy of Yale University School of Medicine. LifeCore officials, however, argued that the gel could help reduce post-surgical scars, which can be painful and cause problems such as bowel obstructions or infertility up to years later. The companies studies showed patients treated with Intergel had fewer adhesions and were more likely to be adhesion free after surgery compared to those treated with a control solution, Dr. Gere diZerega, a physician consultant for LifeCore, told the panel. No serious side effects were observed, he said. "The study is a good one with good results," diZerega said. "The response to treatment is consistent." Because the FDA usually follows its panels' advice, LifeCore will have a tough time convincing the agency to approve Intergel, which is considered key to the company's future growth, analysts said. Thomas Gunderson, an analyst for US Bancorp Piper Jaffray, said LifeCore's stock had gained recently on hopes for Intergel, and the panel's rejection would weigh on the share price when the market opens Thursday. "From the standpoint of stock price, it's very bad," Gunderson said. But he said he thought the data clearly showed Intergel helped some patients, and that LifeCore could work with the FDA to win approval for use in certain cases. LifeCore "could have the product out in a year or less" if the FDA was willing to consider allowing doctors to use it for the cases that showed the most promising results in the trials, Gunderson said. LifeCore makes a variety of surgical and medical devices, including dental implants. Intergel is made with hyaluronate, a synthetic version of hyaluronic acid, a naturally occurring carbohydrate that moisturizes and lubricates the body's soft tissues. Intergel's consistency is similar to motor oil, giving it a flowing liquid motion but making it sticky at rest. If approved, Intergel would be marketed by in the United States by Johnson & Johnson (NYSE:JNJ - news) division Ethicon Inc., which already markets the product in other countries. Trading in the company's shares was halted ahead of a the FDA meeting. Shares of Minnesota-based LifeCore last traded at 22-1/4 prior to the halt.