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

To: Mike who wrote (1183)	1/14/2000 1:46:00 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2001

>> The study design that GLIA is using for Adcon P is not collecting the "end point" data that is now required. << You're expert on the clinical endpoints in GLIA's trial? When I was involved in clinicals, the companies that I worked with treated the endpoints with the strictest of confidentiality. I read the draft guidelines. They simply say that, in addition to preventing adhesions, the sponsor must show patient benefit. What is radical about that? From the draft....... Clinical endpoints of interest with respect to abdominal adhesions are bowel obstruction, chronic abdominal pain, and increased morbidity or technical difficulty with reoperative surgery (laparotomy and/or laparoscopy). >> But the point is that if Adcon L would have been held to this new standard I dont think it would have been approved. << GLIA had their feet held to the fire. They had shown that there was reduced peridural scarring and reduced pain post-op, but it was more difficult to correlate the two. LCBM freaks ought to do a bit of homework. GLIA knows, better than any company, that their trials need to have clear-cut benefit to the patient. I read the draft guidelines. I am USED to reading such guidelines. There was nothing there that surprised me. Nothing has changed for GLIA except that LCBM isn't going to get an early lead on market share. GLIA still needs to produce high quality data that clearly demonstrates patient benefit. Please go do Chicken Little somewhere else.