Replies to post #7115 on Amarin Corp Plc (AMRN)

[finance1229]

Bio, you are simply amazing. Your DD is not just your opinion (as well informed and knowledgeable as you are), but you back it up with facts (directly from the company's public statements). I also heard the CC many times but did not catch everything you did. Forget my own DD. I am just going to read all your postings. Thanks again for your time and dedication.

[yoyo88]

Great stuff, BioBill.

I posed this question to Adam on ST and Twitter yesterday and received no answer, despite receiving direct answers to prior comments/questions:

Me: "Why did the FDA put Reduce-IT enrollment reqs in Anchor sNDA pre-reqs if they were never going to approve it till 2016 in 1st place?"

Him: *crickets ...... tumbleweed blows by*

Following his logic one step further, it begs the question - why did they even approve Marine then? There was already an approved O3 treatment on the market.

It stands to reason the FDA fully understands the difference between V, L, fish oil, Niacin, et al, (despite what one mouthy journalist and Dr Nissen thinks) and asked for Reduce-IT (and subsequent sNDA enrollment requirements) simply as incentive to get the long term study underway. That's it. To imply PDUFA hinges on the trial is irresponsible and uneducated. I think they intended it more as a post-marketing study/P4 trial.

It should also be noted that Matt Herper, Forbes journalist and Amarin skeptic, responded to Adam's Twitter article link with this note of caution:

"Nissen's generally opposed to approving new drugs w/o outcome data so I'm not sure his stance predicts FDA."