…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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”