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

To: RWReeves who wrote (1182)	1/14/2000 12:52:00 AM
From: Mike	Read Replies (1) \| Respond to of 2001

First a couple of points. I am in no way an expert on Adcon P's PMA design. I am also not an expert on the process. But here is the issue that is being discussed in relation to LCBM's experience and denial of approvable letter. First LCBM had a study design to show safety and efficacy. This submission was accepted by the FDA. The study was completed and all the data was collected. Now part of this data was from over seas and not accepted by the panel to be pooled. The current clinical by Adcon P has similiar inforamation being collected. The results of what were collected are not in question. What happened is the FDA came up with a position paper that "changed the rules" by which an anti-adhesion product is to be considered "approvable". The study design that GLIA is using for Adcon P is not collecting the "end point" data that is now required. This change by the FDA is dirty pool in my opinion. I think there is something really funny goinng on at the FDA. Remember I am in no way an expert. In addition, some of the verbage that I am using maybe incorrect. But the point is that if Adcon L would have been held to this new standard I dont think it would have been approved. This puts back therapy for an unmet medical need by up to two years. We need an expert to look at this issue. I really do think Adcon P is going to have serious issues going in front of this same panel and getting approval. Comments appreciated, Mike