Amarin Corp Plc (AMRN)

[Pyrrhonian]

Possible dropout issue?

If you had a TG count over 200, but esp if over 300, and took your "Vascepa," but it was really placebo, and had your levels checked again (as you would routinely if you had elevate total lipds), what's the problem here?

You would immediately identify what group you were randomized to. If no change, or slight increase, maybe you would drop out (assuming you got mineral oil), maybe you would take additional n-3 supps (despite protocol saying not to), or maybe you would decide you needed to do more than take these "fish oil pills," and would eat more fatty fish and exercise more and become more health conscious (cut out refined foods, esp sugars) in an attempt to get your levels down "the hard way." Maybe that works, and maybe you are healthier than a Vas patient who got his trigs down "the easy way."

So, potentially, Vas group will have patients with higher trig counts at baseline *stay in that arm*, while more of these patients will drop out of placebo arm. These patients have high TG counts often because they simply live unhealthy lifestyles (not always, of course). As a group they should experience more MACE. But if more of these drop out of control, that will elevate control group performance due to informed censoring.

Or, they stay in the study and take other measures to improve their health and TG counts, and become a less evented group that way too.

Thoughts?

GL