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

To: arnie h who wrote (1572)	1/13/1999 11:30:00 AM
From: Rudy Saucillo	Read Replies (2) \| Respond to of 2173

There are a number of issues here. Firstly, a handful of PhIII studies have been reported - most recently the Euro study. Each has been marginal to distinctly negative. The Euro study which was designated as "pivotal" also showed some significant safety issues. There is absolutely no reason to believe that results from the ongoing trials will be any different. Regarding the subgroup analysis, AMLN has yet to identify a patient population that will respond to pramlintide apriori. 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." I don't see how this retrospective analysis has any bearing on current trials. Endpoints have been defined and protocols established with FDA agreement. These can't change just because AMLN would like to influence the ongoing trials. OK, let's assume for the sake of discussion that these ongoing PhIII trials turn up positive from an efficacy and safety perspective. AMLN will still have to explain to the FDA why the other "pivotal" studies did not. This is something they can't do. And AMLN simply can't pick and choose only the "best" studies to submit in an NDA package. When a drug candidate fails repeatedly in clinical trials, it's clearly best to cut losses and move on to other work. We're long past that time with pramlintide. Rudy