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Biotech / Medical : AMLN (DIABETES DRUGS)
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To: Henry Niman who wrote (438)8/17/1997 10:23:00 PM
From: David Bogdanoff   of 2173
 
I have been reading this thread today with some interest as I expressed my doubts as to the positive nature of the company press release and cautioned that it be read with caution because announcements from an interested party can be assummed to be biased. Since appeals to authority (credentials) have become part of the discussion, I guess I should state that I have 20 years experience in pharmaceutical company clinical trials. Therefore, I do not see the
company announcement as anything for long investors to be pleased about. If they are pleased, then they haven't learned to read between the lines of the announcement. The announcement admitted that they had difficulty in separating the effects of drug therapy from other factors, such as variable insulin usage. They also admitted that their initial indication didn't pass statistical significance and they
were forced to look at subgroups; this does represent a delay due to the failure of the initial study for the type 2 diabetes population. From what was stated in the news release, it appears that the study design was sub-optimal; this is hard to understand as these patients, their dosing patterns, and problems have been studied for a long time and are well understood. In order for an announcement to be impressive, it should contain words like "dramatic effect" and "completely lacking in toxicity". It would help if the public were pressuring their congressman and the FDA to make the drug available. This announcement did not have anything like that.

In short, Henry, I think your comments are right on the mark (and are certainly not negative hype) and I think the participants of this thread are obliged to you for sharing your expertise.

David
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