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Biotech / Medical : AMLN (DIABETES DRUGS) -- Ignore unavailable to you. Want to Upgrade?

To: David Bogdanoff who wrote (1516)	10/25/1998 2:13:00 PM
From: Rudy Saucillo	Read Replies (1) \| Respond to of 2173

David: I'm not suggesting that any data has been withheld from the FDA or the public. The safety data is difficult to compare between the 2 completed PhIII trials in Type I (and between the 2 completed Phase III trials in Type II) due to differences in dosing and trial duration. For example, the initial Type I trial - 12 months long - used a 30-microgram QID dosing with some patients changing to 60-micrograms QID. The second Type I trial - 6 months long - used 60 micrograms TID, 90 micrograms BID, and 90 micrograms TID. In the second Type I trial, Amylin reports a dropout rate of greater than 30% in both 90 microgram arms and a nausea rate close to 60%. They also report a higher rate of hypoglycemia compared with placebo in these arms. This is obviously extremely poor. My question is: after all of the PhI and PhII studies and the initial PhIII trials, why are we just learning about these serious safety issues? It's something of a moot point since efficacy at best is extremely marginal. The point is that with 4 PhIII studies completed, Amylin hasn't identified dosing that is both safe and effective. The data above was published by BioCentury on 10/21 and, of course, is public information provided by Amylin. Their website is at biocentury.com. If you request the 10/21 "BioCentury Extra", they may send you the pdf file. Rudy