Amarin Corp Plc (AMRN)

[nutsyprofessor]

"2. Appears they're saying R-IT may not go forward without getting ANCHOR data on the label - another threat to pull out of the trial."

Although I definitely understand Amarin doing this and I've been saying this for weeks, the act of actually threatening the FDA with this option will not help their cause, for sure.

"4. It's now clear, even though they didn't say it, that they tried to get "reduced CVE risk" on the ANCHOR label. STUPID MOVE."

Dude, this was NOT Amarin's decision, duh, this was the FDA's requirement, not Amarin's. If it had been Amarin's decision they would have simply run PH3 trials to prove lowering of TG's at levels >200 and left it at that. The FDA does not want to approve a Fish Oil product for lowering TG's in the 200-500 range without having proof of some real benefit other than just reducing a bio-marker.

"Lastly, I'm puzzled by pg 18/19 - $4B-$6B market opportunity just for MARINE indication? And $40B for ANCHOR? What are they smoking?!?"

It is obviously a sign of desperation. They need CASH!!!

"Also have this little blurb at the bottom of page 18, which indicates they want to go off label with docs for CVE risk reduction:"

Going off-label is NOT a good idea. The FDA frowns on off-label use big time, although this is a very low risk and the FDA would probably not worry about going after Amarin. However, the act itself shows defiance and this would not bode well with the FDA.

Also, the added statement about lowering CVE's is no different than going to your local grocery store and buying near similar fish oil products at a fraction of the cost of VAscepa. So going off-label doesn't buy Amarin anything in the way of any real revenue.