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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: Maurice Winn who wrote (1423)1/15/1998 5:32:00 PM
From: Pseudo Biologist  Read Replies (1) of 1762
 
Maurice, I agree in general with your thoughts. The point, from the insurance company point of view, is how one defines "efficacy [having been] shown." For some this means explicit FDA approval as blessed in a drug label; for others may mean "drug is approved for whatever" AND there is credible evidence that it may work for the intended, off-label, use. There lies the uncertainty, in my mind, on whether "IDPH profits are less than they should be" or not.

On Rituxan, more particularly, I am not sure if the little evidence we have for how it may work for intermediate or high-grade NHL (to use the accepted medieval terminology) is good enough at this point -- I need to go over all those abstracts from the ASH conference last month. Another point is that the label indicates it for people who have failed "standard therapy;" so, use for newly diagnosed patients, even with the low-grade disease, would be "off label" as well.

PB
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