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

To: David Bogdanoff who wrote (1511)	10/24/1998 4:39:00 PM
From: Jason Chesshir	Read Replies (1) \| Respond to of 2173

Excuse my ignorance but can someone please explain to me how an investigational drug could yield favorable results in Phase I&II but yield unfavorable result in Phase III given that the only difference between the three trials is patient population size. Thanks in advance.

To: David Bogdanoff who wrote (1511)	10/24/1998 6:56:00 PM
From: Rudy Saucillo	Read Replies (1) \| Respond to of 2173

My comments were primarily directed to Amylin's Phase III program in which they have continuously modified protocols to chase desired results. In fact, they've announced that they will update the protocols of the final 2 pramlintide trials based on the latest results. This is textbook on how not to conduct Phase III studies. The detailed work including protocol iterations to better understand safety and efficacy should be done in Phase II. And the trials sponsors clearly should use the same markers that they plan to use in Phase III. If the learning process isn't basically complete at the end of Phase II, there's high risk for surprises. Unfortunately, there are numerous reasons why companies do an incomplete job during Phase II. The desire to hurry a product to market and the desire to convince investors (funding sources) that the drug candidate is maybe more advanced in the development cycle than it really is are 2 reasons. One thing that infuriates me is that for the first time, we are learning about serious safety issues at multiple dose levels. The 30% dropout rate and 60% incidence of apparently serious nausea must have been seen during the previous trials. The side effects previously have been described as insignificant. I don't believe it. Rudy