Replies to post #100642 on Amarin Corp Plc (AMRN)

[jfmcrr]

What I recall posting was about what can happen when trials stop early vs. not, with an example of a trial that could have stopped early with significance ending up being continued and being nonsignificant on completion.

Yup, I remember that post. I do also remember one where there was a substantial cost in lives to complete the trial. Maybe not your post. Or an acid flashback.Whatever. Thanks

My take on the ethics of an early stop of R-it is that this is an unusual case because V is already approved and available to anyone who wants it (potentially). Ethicists could argue that V as an effective treatment to reduce CV risk is not being withheld since it is already available, and therefore the ethical need to stop early for overwhelming efficacy is not as compelling, and must be balanced by the benefits to other patients (from greater strength of the secondary outcomes) if the trial is continued.

Toss in that the EPA/AA ratio that V achieves is also theoretically available through diet even if the drug is unavailable. A continued to completion trial will make my portfolio's eyes water more than it will make my ethical sense sting...

[sts66]

Ethicists could argue that V as an effective treatment to reduce CV risk is not being withheld since it is already available, and therefore the ethical need to stop early for overwhelming efficacy is not as compelling

That's a losing argument IMO, and one the FDA used at the ANCHOR Adcom debacle - "well, they can always get it off label, right?". We know by anecdotal evidence most doctors, including some cardios, have never heard of V, or don't have much confidence in R-IT success (wait for results before prescribing), or even worse, it's not covered by insurance (Kaiser). So saying "it's available" is really only true for patients with elevated TGs, not those with other CVD risk factors, unless patients take the time to educate themselves and convince their doctor to write them a scrip, *and* convince insurance to pay for the off label scrip. All of that aside, given the somewhat small amount of total deaths we should have in the trial, I can definitely see a case for running it to the end unless 2nd IA produces blowout RRR's and ARR's.