Replies to post #160185 on Amarin Corp Plc (AMRN)

[mrmainstreet]

Man JL, it is weird to see you so nervous after the life you've lived and the leadership you've shown on this board. It was your confidence on not sweating the small stuff since 2013 that made it so easy to keep holding through tough times.

Now we've made it and you're worrying about FUD from short scammers like Pyr? Color me stunned.

You were right the first time that nothing can stop this drug now that the stellar results have been presented to the medical world. Everything else is just chaff in the wind.

I for one have never felt more confident, and cannot wait for 2019! Pyr, DrRX, the scam law firm, and their mineral oil BS aren't going to cause me a wink of sleep.

[rfj1862]

I am a gambler down to my toes

This is the problem.

Give me any trial and I can pick it apart.

Give me any drug and I can pick apart its PI for weaknesses.

No drug and no trial is perfect. The difference here is that while any drug with Vascepa's safety and efficacy results would normally be heralded, there is a lot of money to be made in exaggerating what would usually be accepted as a trivial detail of the trial.

The number one rule in drug development is to not take unnecessary risk. Further, given the interindividual variability in statin metabolism and absorption, what you are asking for would not be a trivial or small trial. It can't be done with any confidence with a small patient population.

Now just stop.

PS: I know you went to Harvard and are therefore smarter than all of us, so no need to remind me when you post your inevitably nasty reply. Maybe you should reimpose your boycott of this board since it is clear that not everyone here understands what a genius you are.

[biowreck]

JL...so is the MO concern by some an issue for the FDA? Do we get the expanded label once sNDA is submitted? I don’t trust the FDA...and if they failed us....it would be the ultimate sham....

[IgnoranceIsBliss]

JL, you're the Harvard guy, and I'm just the blue collar elf with a degree from the College of Hard... uh... Knocks, but... I'm going to have to disagree with you here.

Obviously you have to take the viewpoint seriously, but you also have to consider the source. Do you really think the cardio world doesn't know that the co-author ran the EVOLVE trial and is getting paid by AZN?

The op-ed ends like this:

"In conclusion, after a parade of failed cardiovascular outcome trials of fish oils, REDUCE-IT has shown a substantial benefit with respect to major adverse cardiovascular events. More data are needed to confirm these effects and to inform an understanding of the mechanism of action, the uniqueness of the compound tested, and the potential influence of mineral oil as the comparator. However, the finding that the risks of several cardiovascular outcomes were significantly and consistently lower with icosapent ethyl than with placebo make us hopeful that the use of icosapent ethyl can substantially improve cardiovascular health in patients with statin-controlled LDL cholesterol levels who have elevated triglyceride levels"

Read it slowly. All he is saying is that the trial does present us with some unanswered questions? WHY does EPA reduce CV events, exactly? We acknowledge that that hasn't been fully parsed out. Even with full label expansion, AMRN is going to keep running trials on EPA. Hopefully LOTS of trials.

Uniqueness -- this is self-serving, will STRENGTH show Epanova does it as well... that's not an argument for not approving Vascepa, at all. You don't get to stop one approval because another drug may be coming later.

They end by acknowledging something big has happened. Their skepticism is evident, but it's stilted -- and everyone reading the article other than Steve Nissen's wife and Pyrrh can see that. They KNOW it's getting approved. They just don't want to see their drug (which will fail) get run over.

This is not stopping approval. This is not slowing approval. Sunlight is the best disinfectant. The data is out there for all to see.

[Yoyippie]

Why can't the nejm be corrupt? When there are people involved there will always be corruption/ manipulation

[mapman1010]

jl i agree with everything you wrote.. up to this statement:

I feel very nervous about next week..

and everything after.
what if i was to postulate that the 'Street" had knowledge of JT's pre-arranged sale?
i would never consider thinking i am smarter than you but i would consider thinking i have experienced the market differently than you.
i am not nervous about next week even though i have 25 contracts for Nov 23 $20s. my bad for not rolling them first thing Monday morning.. frickin customer had me tied up until 11am. Oh well gambler's curse.