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


To: David Bogdanoff who wrote (1575)1/13/1999 5:20:00 PM
From: Rudy Saucillo  Read Replies (2) | Respond to of 2173
 
My point is that the FDA will not approve this drug candidate based on subgroup analysis. The subgroup analysis itself is meaningless since the analysis doesn't show what patients *statistically speaking* may benefit from usage *prior to the actual usage*! And *yes* the FDA is very concerned about what patient populations will respond to drug - irrespective of which NDA you want to discuss.

Rudy