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Post# of 252476
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Re: DewDiligence post# 222163

Monday, 11/12/2018 2:51:26 PM

Monday, November 12, 2018 2:51:26 PM

Post# of 252476
Changing absorption of statins is a more plausible MOA.

In the previous AMRN trial the FDA AC briefing commented on a similar rise:

"During the review of the MARINE data, the Division noted that several lipid parameters (including TG) increased from baseline to week 12 in the placebo group, treated with mineral oil. The available literature regarding potential effects of mineral oil was considered. Similar increases in TG levels observed in the placebo groups from the Lovaza (omega-3 EE) clinical trials of hypertriglyceridemic patients were noted, and these trials did not use a mineral oil Because no strong evidence for biological activity of mineral oil was identified, ultimately it was concluded that the between-group differences likely provided the most appropriate descriptions of the treatment effect of AMR101."

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