Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

SO, some facts on the STRENGTH trial

(I've been doing real DD while you all have been fussing like teenage girls...)

The trial has futility looks at 50% (800) and 75% (1,200) of events.

It is clear that the trial survived the first futility look, where the p-value (I think, I need AVII) was around .5 -- that would have confirmed that there was at least a minimum, minor level of efficacy being observed -- at least RRR of 4.6% or so.

And that makes sense to me. There's a JELIS level of EPA in 4g of Epanova... and even with the negative effects of DHA, some residual efficacy should remain.

They should now be coming up on the 75% futility look, where the hurdle is considerably higher -- the p-value at that look should be around .12 or a little higher -- I saw .124 in a statistical presentation online. (I have to rely on internet stuff I find -- I understand efficacy boundaries because they are simpler, but I'm too dumb to understand the other side -- this is another reason I need AVII for this.)

The RRR required to clear the p = .124 futility hurdle at 1,200 events is about 8.5%. I think it is conceivable they could clear this, but unlikely. In any case, I think it is coming very soon.

I should also say it's possible that the 75% look already happened, but the chance of that is low. Given the dates they published for the start and end of enrollment, and a reasonable assumption about the enrollment pattern, AND the fact that they have advertised Oct 2019 as the month the 1600 events should be reached, it is quite possible the data is being analyzed for the 75% interim look right now.

I'm not sure what to root for. A trial stoppage for futility would remove AZN's motivation to slow Vascepa approval, but it would also add fire to the nitwits who want to say Omega-3's don't work.

In any case, it's a fact that's out there. And now you know it.