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Re: biomaven0 post# 143366

Wednesday, 06/06/2012 11:55:29 AM

Wednesday, June 06, 2012 11:55:29 AM

Post# of 257253

I hadn't realized that. But they are pretty much obliged to dose according to the label in a trial even if that isn't the de facto standard.

In this instance, Roche might have been able to dose Humira using the de facto standard because the language in the FDA label leaves some wiggle room about weekly dosing w/o methotrexate.

Clearly, however, it was in Roche’s interest to under-dose the Humira patients in the ADACTA study, so that’s what they did. Most pharma companies would probably have done the same.

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