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

To: jbershad who wrote (1374)	5/17/1998 1:57:00 AM
From: D.Right	Read Replies (1) \| Respond to of 2173

Dear Jerry: Some thoughts on ERGOSET's rejection by FDA and pramlintide's chance. 1. One complain by FDA panel is only 24 weeks data from ERGOSET. Pramlintide has positive one year data on type I already and more on its way. 2. Mechanism for ERGOSET is not clear. For pramlintide, as the adjunction hormone of insulin, the mechanism is there. 3. At 0.5% HbA1c reduction, ERGOSET is better than pramlintide's data so far and considered "moderate". It did not get the "yes" vote was because there are many other drugs already and ERGOSET did not improve patients' condition on top of sulfonylurea. For pramlintide, it can improve on top of insulin and no other drug can do that for type I. 4. Safety. It is a big concern for ERGOSET. I think FDA is super-sensitive to this after the liver problem with Rezulin. Let's call it after Rezulin Syndrome. Pramlintide has great safety profile so far as a hormone replacement. 5. Money. ERGO did a great job at doing trial faster and spending less money than AMLN. However, as they didn't get the "yes" vote, AMLN's longer, more expensive approach may not be that bad after all. Read Mr. Greene's comments on the delay from last Nov. It makes sense now. 6. AMLN doesn't have JNJ to screw them up anymore as ERGO does. What a relief. (This one is a joke) 7. ERGOSET's placebo has increased HbA1c while pramlintide's placebo has decreased HbA1c. I think pramlintide should have more credit here as well. 8. Strong data for type II is a must for approval for pramlintide. Good weekend. D.Right