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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (26675)	11/25/1998 12:23:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

george, I strongly suspect that he was on the panel because he had AIDS, not because he was a scientist/doctor. I think that he was representing the "end user" or impacted population, and his panel membership was mandated. I used to be on an institutional review board for certification of Scripps' animal facility. The composition of the board was dictated by the certifying agency, and in addition to a veterinarian and scientists who used the facility, there was a lay person appointed to represent the community (and he had no advanced degree or experience with animal experiments). I believe the the composition of the FDA advisory committee is similarly mandated (with representatives from industry, academia, government, and targeted population). Moreover, it is my understanding that the FDA Modernization act did away with rejections based on market conditions. The risk/reward ratio is supposed to be calculated on safety, and the marketing aspects are supposed to be left to the marketplace. If patients and doctors do not find value in the drug, then it will not be used, even though an approval had been granted. As I said earlier, of those following FDA guidelines, the approval vote for Panretin was really unanimous (8-0).

To: aknahow who wrote (26675)	11/25/1998 1:41:00 PM
From: Machaon	Read Replies (2) \| Respond to of 32384

<< It is difficult to imagine anyone on a panel turning down a drug based on the panel members view of the market for the drug. >> I agree. Perhaps this shines some light on his reasoning that the skin irritation, caused by Panretin Gel, was more serious than curing the malignant cancerous KS lesions. That fact that patients, in the trials, wanted to continue using the gel, and continued to improve should bear a heavy weight on Panretin's value in treating KS. It would be interesting to know if the AIDS member of the panel had KS. I think that only a minority of AIDS patients get KS. Well....... tomorrow is Thanksgiving. I wonder if the FDA is meeting on Friday, the deadline for a decision on Panretin? Have a Happy Thanksgiving....... Bob