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Biotech / Medical : analysts and calls -- ML

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From: tom pope	9/2/2005 11:50:54 AM
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MGI Pharma (MOGN, $27.04, C-1-9) Reiterate Buy. Dacogen (MDS) Delay: Lowering PT from $31 to $30. Lowering 05E from $0.31 to $0.25 and 06E from $1.25 to $1.13. While we were expecting a launch in 4Q, Dacogen should still receive approval, albeit 3 – 9 mos later than expected, & drive the next leg of rev & EPS growth. Because phase III Dacogen data clearly demonstrated an improvement in transfusion independence, it is unclear as to what type of analysis the FDA is requesting. Class 1 resubmission: requires FDA response in 2 mos. Class 2 (which is what we are assuming with a mid '06 launch): requires FDA to respond within 6 mos.

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