Amarin Corp Plc (AMRN)

[TastyTheElf]

My Saturday STRENGTH trial musings, which could be timely, given their 75% interim look is probably happening right about now.

There appears to be an interesting innovation in the design of Epanova that I hadn't really noticed -- it's this SMEDS delivery system (something to do with emulsification) which improves absorption and therefore might, among other things, make it unnecessary to take it with food.

That sort of thing might allow 2.2g of EPA to get much closer to the efficacy of the 4g of EPA-EE you get with Vascepa. The possibility has to at least be considered.

The two offsetting problems, of course, are trial design and DHA.

Regarding trial design, as AVII so clearly pointed out, it could end up biting them ironically, BECAUSE they had the resources to enroll more patients and accelerate the study. Presuming they experience the same phase-in (delayed separation of curves) that R-IT did, a median follow-up of 3ish years is very unlikely to get the HRs we got with a median follow-up of almost 5 years.

But here's another thing I didn't think of before. Epanova only has 200mg of DHA per pill, but what if the SMEDS system also improves uptake of DHA. That's the last thing in the world you want. If SMEDS ends up creating DHA levels that are effectively Lovaza level or higher, then you'll have the same level of LDL-C problem, and the same offsetting effect in the STRENGTH trial.

My prediction for that trial, based on this additional self-indulgent musing, remains where it was before. I think the trial will barely survive the 75% interim look (maybe RRR of 7% at that point), and at the final look, the trial results will hover just around the stat sig level -- somewhere between 9% and 10% RRR.

This is the absolutely best result for AMRN, as it would validate the EPA thesis without creating a viable competitor in the space. The story would be so easy to tell: "Yeah, they had more EPA, so that helped, but the DHA shouldn't be in there. In other words, they needed Vascepa."