Amarin Corp Plc (AMRN)

[bogatie]

Question for MRC

I read your Citizens Petitions. I have a question regarding pages 7-8 of your first Petition. You state that given the percentages of Placebo Arm patients (mineral oil) on low, medium, and high dose statins, the pre-statin controlled LDL-C (Hopkins) would have been 146 mg/dl. (This is the number I came up with as well.)

Here is the question: since starting Hopkins LDL-C for placebo arm was 86.7 at baseline, if mineral oil blocked most of the effect of the statin, why did the median not go back to 146? (The highest it ever got was 96.1)

The worst year for placebo LDL-C Hopkins was year 2 at 96.1. 96.1 is not 146. The bio marker LDL-C indicates that actually the statin dosages were still very effective since below 100 LDL-C is "optimal."

Not a question, but more of a note, you choose 96.1 mg/Dl at year two as the "correct" placebo LDL-C number and disregard that by years 4-5 placebo LDL-C was at 91.6 and 92.1 respectively. You state that this occurred by year 4-5 because patients were dropping out and stopped taking their mineral oil. The fact is, you have absolutely no evidence to make such an assertion. You cherry-picked the worst year (96.1) and then have an unsubstantiated reason for why placebo LDL-C is lower in years 4-5.
At other points you make similar unsubstantiated assertions - such as what time of day people would have taken their medications. In reality, you have no proof as to whether patients in REDUCE-IT took their medications with meals, at bedtime, etc. If they followed instructions, most would have taken the placebo at meals and their statin at bedtime. We have no evidence (your footnote notwithstanding) that most did not follow the prescribed regimen. You assume that to imply that most of the patients were taking their mineral oil and statin simultaneously.

There are lots of other big errors in your work, but the seminal one is the question I ask - why did LDL-C not go back to 146 from its start of 86.1? Please give a logical answer.