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Biotech / Medical : InterMune (nasdaq)ITMN
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To: quidditch who wrote (289)8/28/2002 11:28:54 AM
From: Biomaven  Read Replies (1) of 508
 
quid,

I think we might well see statistical significance for mortality for the whole group as they continue to follow them over time. The drug group is in fact getting a few more months of treatment before the placebo group is switched over, and given that the drug takes at least six months to kick in, the Kaplan-Meier survival curves should continue to diverge. (This is what we saw in the small Vienna study).

Note this continued observation was pre-determined and agreed to by the FDA. If the curves do continue to diverge, then my feeling is that the FDA will approve this indication, missed primary endpoint or no. I'm not sure we'll ever get significance on the primary endpoint itself, but to my mind a mortality benefit trumps lab tests.

My options are mostly toast, but I did pick up some more shares cheaply this morning in the pre-market.

Peter
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