Amarin Corp Plc (AMRN)

[Anonymous Fish]

Here's the archived webcast of the ADCOM if anyone is interested:

https://www.fda.gov/media/132476/download

My connection was garbage last week so only got round to listening to it properly today.

Multiple panel members have issues with the mineral oil and statin absorption thing and a pharmacokinetic study was suggested by the chair as it would be "relatively easy to perform" as "we are not looking for endpoints, we are looking for absorption, ehm pharmacokinetics".

The discussion then got a bit muddy as they couldnt determine when exactly the placebo and statin were administered during the trial - before food, after food, what time of day etc? The chair then asked Amarin to get back to them to clarify but I dont think that they did.

Its one thing performing a pharmacokinetic study on a mineral oil placebo and a statin on an empty stomach and another thing entirely to perform an analysis with a belly fully of food and a statin and a mineral oil placebo. The results will not be consistent so I think its very unlikely that the FDA will request it.

During the discussion before the vote and after the vote the subject was not brought up again by anyone which suggests to me that they are going to let the placebo/inertness statin absorption issue slide and defer to the existing science which suggests that any potential mineral oil statin absorption issue could only account for about 3% of the total efficacy. Good news for Amarin obviously because if the requested that study and issued a CRL telling Amarin to resubmit the sNDA once they have it, it would set back approval by about a year.

Also seems very clear from listening to the ADCOM that Amarin havent a prayer of getting the Primary indication label but that the Secondary prevention label is pretty much guaranteed. If they want Primary they will have to conduct a whole new trial with a different placebo.

The label they will approved for will be for patients on statins LDL-C between 40 and 100 with established CVD, with TG's >150mgs/dL,and aged greater than or equal to 45 years old.

Anyone know what is the patient population in the U.S for the secondary prevention indication? I think I remember seeing it on an investor presentation a few years ago but its been removed now. Was it estimated to be ~35 million?

Messy looking TA chart with a major battle going on between the bears and bulls the past few days. There's big big players involved that clearly disagree on what the value of Amarin is worth upon an expanded secondary prevention label. I'll post a chart once the volume settles down a bit.