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sts66

10/09/17 3:25 PM

#115814 RE: HDGabor #115633

The FDA tried to explain the changes observed in the mineral oil group, since the magnitude of the changes in several lipid and lipoprotein parameters, as well as biomarkers of inflammation, between baseline and Week 12 in the placebo group wre rather atypical for lipid-lowering trials



I don't recall in the BD's about the mineral oil group and any other biomarkers except for TGs - perhaps you are referring to a discussion during the Adcom itself? Below is the BS screwed up x-axis scale from the BD's they used to claim something weird happened with TGs in the drug vs. placebo group: