3 things for prospective longs to consider leading into ADCOM
1. Mineral oil placebo
IMO, even if mineral oil were shown to stat sig increase primary/secondary endpoints of ANCHOR patient population wrt an uncontroversial placebo, it does nothing to discredit Vascepa's individual performance. FDA approved the MARINE indication with little controversy (and no adcom). If they truly had a concern with regards to the mineral oil, why would they approve, and w/o adcom? Doubting the placebo-ness of mineral oil would certainly be grounds to dismiss all of Amarin's completed and on-going trials. Christ, we're talking maybe 4g of this oil... Even if it weren't "inert", actually impacting the results in a measurable way is a tall order from such minuscule amount of oil.
2. Non-inferiority test for LDL secondary endpoint.
This is the most bizarre critique in the BD. The FDA agreed to the SPA, and why wouldn't they? Currently available treatment options lead to stat sig increases in LDL, wrt to placebo, w/ TG reductions. Amarin showed that it is non-inferior to placebo wrt to LDL, which is sufficient to show superiority to those that are stat inferior to placebo. Secondly, this is a secondary endpoint... Rejecting ANCHOR off a slightly different choice for comparing the arms in a secondary endpoint seems absurd... This isn't the overall survival vs PFS debate in cancer where LDL would be considered more important than TG. Not increasing LDL while decreasing TG is the entire selling point of Vascepa.
3. The #2 point here, combined with the wording of the #2 question (the voting question) in the BD, leads me to believe ANCHOR approval in the bag but the FDA is simply deliberating on how broad a label. FDA may be reluctant to say Vascepa reduces LDL (as opposed to just saying it doesn't increase LDL). Further, FDA not asking panel to vote on approving Vascepa for ANCHOR population, but rather REDUCE-IT population. This is a big vote of confidence for ANCHOR approval IMO.