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DewDiligence

09/07/10 10:11 PM

#103698 RE: mcbio #103695

…I'm surprised that [combination] pre-clinical tests weren't done before the DDI study in humans just to flesh out any side effect issues from the combo, but I guess hindsight is 20/20.

I expect the DDI study we’re discussing to induce an FDA policy change. From now on, combination animal-tox studies will likely be a prerequisite for trials testing a combination of unapproved HCV drugs in either patients or healthy volunteers.