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

To: Rudy Saucillo who wrote (1574)1/13/1999 4:13:00 PM
From: David Bogdanoff  Read Replies (1) | Respond to of 2173
 
R:
<< It's meaningless to say that patients who respond to pramlintide within a month will have a long term response. The FDA will simply
not approve a drug based on this "trial period." >>

Point of clarification. A company does not have to identify apriori who will benefit from its drug candidate; it just has to show statistical significance in the target population relative to placebo or standard treatment. There are plenty of approved drugs that don't work for a percentage of the population and are discontinued in those patients but are continued for those patients for which they are efficatious.

Also, the history of drug development is replete with cases of drugs not working for one application but unexpectedly having another benefit. Too soon to deep six pramlintide, imho.

David




To: Rudy Saucillo who wrote (1574)1/13/1999 10:40:00 PM
From: arnie h  Respond to of 2173
 
Rudy: Thanks much for your perspective. In the past few days, the company has put out 3 forward looking plans; it's as if they are back to where they were before the trials crashed. Astonishing. I presume we'll know soon whether this is all smoke and mirrors or whether some kind of an arrangement has been made that establishes a more secure future.

Appreciate your input,
Arnie


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