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Biotech / Medical : AMLN (DIABETES DRUGS)
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To: Henry Niman who wrote (530)8/19/1997 7:17:00 PM
From: David Bogdanoff   of 2173
 
Henry;

My understanding of the press release I saw was that there was simply increase and/or variability in insulin usage unrelated to treatment group. Yes, this does make it difficult to statistically detect treatment effect from natural variability, if that was the endpoint(still not certain about that). Various statistical techniques exist to deal with that problem: increase sample size, stratify on stability of insulin usage. This is were they failed, imo. What we appear to have is an unclear study outcome due to poor study design.

David

This isn't the only explanation. Perhaps the body adjusts to the presence of Pramlintide after 6 months and reverts to status at start of the trial. In this case, the patient might be hooked on Pramlintide or face adverse withdrawal effects(just pure speculation on my part)!
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