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Re: mcbio post# 103695

Tuesday, 09/07/2010 10:11:25 PM

Tuesday, September 07, 2010 10:11:25 PM

Post# of 257266

…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.

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