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Message: Re: Amarin CEO interview
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Nov 12, 2018 02:35PM
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Nov 12, 2018 02:50PM

I have no worries about Resverlogix choosing a proper placebo. Pills/capsules/tablets of a white powder chemical substance are easy to placebo control. Apabetalone can be easily placeboed (is that a word?) just like most other oral drugs.

Amarin needed to placebo an oil to match the colorless purified EPA ethyl esters. In my opinion, a purified version of a vegetable oil (corn, soybean, canola, olive etc) that was refined and/or bleached to the point of being colorless would have been the logical choice. I've been doing fatty acid/dietary research for years and years and you always want your control variable (diet, fatty acid, etc) to be as well matched to the test variable as possible. Mineral oil is just unforgiveably stupid. They could have had a clear cut winner still in REDUCE-IT if they used a more physiological oil control as described above. But now all these questions and caveats remain. The FDA, Amarin and the REDUCE-IT Clinical Steering Committee deserve ALL of this criticism coming their way right now. They really did a disservice to the medical community and patients by confounding their trial with mineral oil.

BearDownAZ

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