This placebo thing taking on a life of its own. I got up in the wee hours last night to take a leak and of course as usual checked this board. I saw PD's post sounding some alarm bells. I don't quarrel with PD but as I went back to bed I could not sleep thinking about out dire straits - defending our star drug and sitting at less than $2.
Eventually my mind drifted to the days before R-I results. R-I was an event driven trial. For many months prior (years) to those results people on this board discussed how the longer the trial went, the greater the chance for success. Some sharp minds tackled it from the math perspective and calculated what the event rate might based on the date of trial termination and chances of success.
One thing that had to be taken into account when performing those calculations, was the placebo event rate. That had to be estimated. So people started using placebo event rates from previous CVD trials as guideposts. Some here mentioned that over the years, typical placebo event rates were getting better as patients were taking better care of themselves - diet, exercise, habits, etc.
So laying in bed thinking about this MO placebo stuff, my thoughts boiled down to this:
First, how does the placebo event rate in Reduce-It compare to other similar trials? Is it about the same or is it grossly higher than previous trials hence promoting the thought that MO causes MACE?
Secondly, how does the active (Vacepa) arm event rate compare to other similar CVD studies? If V doesn't work at all then it should be about the same as other trial placebo event rates. IF the Vascepa arm event rate is lower than those other trials then Vascepa works as we think.
So since my piss I have not gotten much sleep. I still come back to the Olshansky et al paper that I believe sums up the case that MO could not have possibly caused a huge effect in Reduce-It. It is not detectable in the blood and the only thing that I see in the paper would be some MO accumulation in the liver. Statins work on the liver, but the paper clearly distinguishes between pharmaceutical grade MO and everything else.
"Some studies showed mineral oil bioaccumulation in humans as a result of exposure to industrial-/technical- or food-grade mineral oils, which have been detected in fat, mesenteric lymph nodes, liver, and spleen, with lower levels in the lung, kidney, brain, and heart.33 These mineral oils are derived from food, cosmetics, release agents, lubricating oils, dust binders, packaging materials, and environmental contamination.1,3 Bioaccumulation of industrial-/technical- or food-grade mineral oil has been reported with longer durations of oral exposure, particularly for n-alkanes with 20–40 carbons.34 However, similar to above, these findings do not apply to pharmaceutical-grade mineral oil."
Hey to say it is not concerning when we have real money on the line (or at least we did when the stock price was in double digits) would be fibbing, but CVD drugs for the vast majority are not approved because of biomarkers (other than maybe LDL). It takes 6 months or more before the FDA approves or denies a drug application, so they certainly had plenty of time to look this over.
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