Replies to post #220413 on Amarin Corp Plc (AMRN)

[Mocha Loca]

I'm not Jesse or Bio, sorry, but I believe this is a non-issue. The FDA has been aware that "indiscriminate" intake of mineral oil could cause malabsorption of these vitamins for at least a few years. The primary purpose of white mineral oil is to relieve constipation and you swing down about 15-30 or more grams. That splashes through your esophagus, so subsequent food intake may get coated, and into the stomach like a shower. So, if there is food in your stomach, it might get coated as well. If you do this on and off for months, there may be some malabsorption of those vitamins. But in REDUCE-IT, you take two gelcaps that dissolve in the stomach over about 30 minutes which has very minimal to no effect on absorption. The DMC would have been aware of this possibility but they noticed no real effect in their safety reviews. In fact, the date on this article is from 4/1/19, so if their were any concerns the FDA had about mineral oil, they would have immediately scheduled an AdCom since they just received Amarin's sNDA. It's not an issue.

[massulo52]

The results are the results. No matter what.

[jessellivermore]

johnking...

Please understand Bb's opinions and mine are not the same..He has a right to post what he believes...I have a right to disagree....

RE: Your question which I guess is does FDA think Mineral Oil is a big.deal...
Ans: I don't know..I don't work for FDA and I don't have inside sources...Historically FDA has not considered MO as to be a serious issue.
I don't see any recent scientific evidence that would make them change their minds. Since I do not think FDA is a lying, cheating, sociopathic organization modeled after a James Bond plot...But rather is federal bureaucracy that does its best but is subject to human errors and the unpleasantness of a hierarchy..So they do make mistakes...

I think FDA will side with company that the MO is not important..Same as they did in MARINE and ANCHOR...

":>) JL

[sts66]

FDA is not suddenly interested in "lack of absorption" due to "injesting Mineral Oil at mealtime" - that CFR was updated back on April 1. And they're referring to it's use as a laxative at a dose 10x to 20x the dose given to placebo patients in R-IT - no way a couple grams of MO does anything to prevent absorption of fat soluble vitamins or statins.