No horse in this race, but I'm always drawn to names that are blown up to see if its warranted. I have gone through the FDA document to try to understand all the fuss. It appears to me that part of the issue with the reaction is the hypothesis of the FDA reviewer that the results are "overstated" because of the use of the mineral oil in the placebo arm. So if we start there, what the FDA reviewer is saying is that the mineral oil some how inhibits the uptake of the statin. So I've done of search of all the literature on Simvastatin (most used statin in the trial) and I have found NOTHING in the medical literature or databases that states there is any interaction between the statin and mineral oil. There is also nothing in the label of any of the statins warning that mineral oil intake inhibits the uptake of the statin. So I find it very curious that the reviewer can make this statement when there is no evidence of any interaction between the two. So the question is, why would the reviewer come to this conclusion that the benefits are "overstated" because of the mineral oil and statin in the placebo arm if there is no evidence that mineral oil has any interaction with the statin drug class? I don't get that one bit. Hopefully, the docs on the panel address this, because as is, the data is pretty impressive.
Not only this if you look at the wording I saw once instance
where the reviewer talk about the effect of placebo she used the word
HIGHLY statistic significant. Whereas for vascepa although result
is highly stat sig in some area but reviewer did not put in the word 'highly'.
Also reviewer seems like anticipating what amarin is going to bring
in for discussion and shot down those 1st as a pre-em. Especially the
jelis trial. The while bd imo is like drafted by serveral lawyers and
doctors to counter whatever amarin are going to bring to the adcomm.