Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Ajax, you have it exactly and precisely bass ackwards with your statement:"Amarin has a unique opportunity to play nice and show the ability to compromise with the FDA."
Yes...Amarin has always had this opportunity and ability, however a review of the facts would clearly demonstrate that it was, in fact, the FDA that had no interest whatsoever in either "playing nice" or compromising that led Amarin to seek judicial remedy with regard to the issue of NCE and the First Amendment. You will, of course, recall that in both of these instances Federal Judges found for Amarin. In the NCE case, the FDA has still not issued NCE status for Vascepa™ and in the First Amendment case the Judge issued a Preliminary Injunction and directed the parties to craft a solution.
Why do you suggest that Amarin is the recalcitrant party?
ccm3; I hope that you will not let anyone get under your skin to the point where you leave this MB. Your posts are among the most well reasoned and indeed valued by the vast majority of us.
Ajax, Your statement;"I don't think they are concerned about shareholders, that is until the Baker Bros got involved." is yet another example of your reluctance (or inability) to see things as they are, not as you wish they had been. With that in mind, I'll append your statement" Forget Mother Theresa, another Martini for Mother Cabrini." with: and another large swig of Geritol for Ajax!
There is little to be gained in "shoulda, coulda, woulda".
So very gallant of you to come to Kiwi's aid, sts66. I've been around here a while and have a pretty good sense of when someone's pissing on my boots and trying to convince me that it's actually a rainstorm.
Thanks for the clarification, Kiwi.
Kiwi: In fact you have 23 (yes, 23) pages of posts regarding Amarin (and solely Amarin) on iHub that you have posted in the year 2015. So as to your intent to seem that you have any diversification, I again say B.S.
For anyone that would like to verify what I say here, simply "click" on Whalatane's, blue name and scroll through 23 WEB PAGES of his "helpful", posts... every single one relating to AMRN.
Deversified, Kiwi? I sincerely doubt it. It would appear to this less than casual observer that you have a rather obvious SHort agenda.
Fishydigits: Re: Your question:"A large part of me wonders if Vascepa will ever be approved as a triglyceride lowering agent, no matter how good the R-IT results are."
Vascepa® is already FDA approved as a triglyceride lowering agent.
RE Motley Fool: It has been my observation that the last part of that poster's moniker is spot on. Beyond that....if Motley Fool's posters (posers) were sincere, qualified, Educated and most of all, transparent with respect to their author identities, I might take them a very tiny bit more seriously. Franky, I think their "papers" are suitable, at best, for lining the bottom of the birdcage of some fine feathered creature that dines exclusively on prunes.
If you're going to make bold statements on a public forum where you are trying to garner credibility as as knowledgeable "author". then have the testicular fortitude to ascribe authorship to your actual, legal name, or, IMO, consider yourself to be a "hollow drum" douche bag.
Thanks again for posting Rx #s, Sam! Scripts are looking good
What was the volume on that $1.58 print that you mention? Of note: there was also a 2 million share print @ 2 bucks yesterday. I would love to hear opinions of how, if at all, these two events affect each other in terms of "coloring the picture"? Thanks.
The debate continueth... http://blog.constitutioncenter.org/
Freak: Your statement "I hope I'm wrong, but I'm not" is simply more of your inane, "short-wish" drivel. You really do not know if you're right or wrong....you are simply betting (and shorting) on wishful thinking. The Science obviously goes over your head as does other logical postings on law, procedure etc. I know that you love your own voice, but frankly, your credibility is less than zero. Why not try taking your non-substantive rants over to YMB or ST and save yourself further ridicule and humiliation.
Dear Mr. Freak, If "nobody cares about this stock", can you please explain why you routinely drop in to post articles simply bashing it? Perhaps your rants would be better received on YMB or ST as most of the users of this forum tend to include at least modicum of substance in their posts. Have a nice day!
Interesting theory JL, and, IMO, entirely plausible. (BTW; Please remind me that I never wish to be your opponent in a game of chess. )
" ....Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial (CVOT)."...
(In best Mr. Rogers voice)"Can you say arbitrary?....I knew ya could".
My reply was simply answering the question as it posed.
I agree, Louie.
Up to the "level" of person having the authority to make a legally binding agreement between the FDA (Government) and Amarin with respect to the matter or matters being agreed upon. Of course, we have seen agreements with the FDA (The SPA comes to mind) wherein the fact that an agreement was apparently reached and documented only to have the document turned into a piece of toilet paper. That being said, I would imagine that FDA would be reluctant to screw around in this case.... probably not the best time to piss off the Judge.
I'm not certain that Amarin investors necessarily wish to have their identities known, thus I'm thinking that Facebook is probably not a great platform on which to hold discussion for obvious reasons.
Pun intended?
Yes, North, having Judge Englemeyer present at any location that the meeting would take place at would be excellent idea. Unfortunately there is no way that I am aware of that Amarin to compel that to happen.
North, I agree with you 100% that the discussion would best be held in Judge's chambers. I also think that's the last place on earth that FDA would pick as a venue for this pleasant little get together. The only advantage that I can see to holding the meeting on FDA's campus is, as Louie points out, there would likely be people physically present and available that cold sign off on contentious elements of the agreement that the Gov't's lawyers would have to go back, confer, explain, confer, explain etc.
Is Husten smoking crack or simply kissing the crack of shorts? His statement: "For one, it bears remembering that Vascepa is a nutritional supplement. " is 100% incorrect in terms of FDA drug v.dietary supplement. Someone ought to straighten him out. (BB?....Bueller?,Bueller?)
Great question, JL! I am not aware of anyone approaching from that angle.
I'm not a "medical person" but in the course of investing, I've read a fair technical drug information/labeling info etc. which often contain statements essentially saying: "We are not certain of how (by what mechanism) this drug work what it does, but.... it is demonstrated to be effective.
Thanks, North Good catch re Dan Troy. His employment history is interesting indeed. I wonder if he still maintains relationships with the good folks at FDA...
Thanks for setting me straight on that issue, BB although that doesn't make the situation any less fetid. By Oct, Lovaza's patent were basically worthless (I don't recall actual expiry). Do you think this was preemptive move by Woodcock to secure a nice warm empty bed for Epanova? If not, what was the likely strategy other than to screw Amarin?
Considering the fact that a large portion of Lovaza's scripts were reportedly written "off label" (coupled with the messy situation in China a few months ago when GSK was found to have engaged in bribery leading to a five hundred million dollar fine and the firing of 110 reps), I personally find it difficult to believe that Glaxo didn't have reps promoting L for the 200-500 mg/dL population. I'm not making an accusation here, but it does seem to require a bit of a stretch of the imagination.
Thanks for the link.
Re: Getting the word out, the newswires have started running this and there will doubtlessly be a significant amount of discussion and articles written about the ruling. More importantly, the word on Vascepa's therapeutic benefits will now get out to doctors and other HCPs as a result of what was essentially a gag order having been lifted off of Amarin's (and Kowa's) reps.
How's that prediction on how the Court would rule working out for you, ricardoga? I'm guessing, as evidenced by your silence, that it's not working out too well.
Freak; you seem bitter. I'm guessing that you had placed a lot, in fact, way too much $$ on the decision going the other way.
Would one of our posters with PACER access please post Doc, thanks! This is really wonderful news!
Thank you, JL, really great post that helped me immeasurably in finally understanding how V's efficacy in R-it could be statistically predicted within a moderately tight range. I always appreciate your well reasoned (and well tempered) posts.
JL, I think your response to zip is exactly correct.
Perhaps, but don't you think the same peril existed for FDA in the Caronia matter? IMO, that is where the FDA lost the fight. Based on accounts of people that claim to have been in the courtroom, the FDA (Government) does not seem to have made a particularly compelling argument.
AI agree that Caronia precedent was instrumental in Amarin filing this suit, however, I disagree with the second part of your statement: "If Amarin wins, it opens the door to other cases. The FDA will appeal this time IMO."
The cows were already out of the barn with Caronia. Inasmuch as FDA appears to have not appealed Caronia on the basis of knowing that they were on very shaky Constitutional ground, they must surely be aware that appealing a loss to Amarin in this matter would be an extremely slippery slope ... they would basically be forced to try to re-argue BOTH Caronia in terms of principle and Amarin in terms of seeking to overturning the ruling. I don't see FDA electing to take that path considering the risk to their omnipotence.
I think it unlikely that the FDA will appeal if they lose (just as they didn't appeal in Caronia). They would probably rather "concede one" to Amarin rather than risk opening up the entire matter in case that would potentially grant all BP a blanket immunity from prosecution for disseminating truthful, non-misleading information, thus limiting their draconian grip on the industry.
Whoa... what was that about?? (Big sell)
Has anyone else noticed that the level of "chatter" and FUD from shorts has been markedly elevated over the last day or two here on iHub, on ST, on Yahoo etc. etc.? I see this as having rather Bullish implications. It would seem that they a bit more nervous than usual and with each additional post, display their apprehension even more.
Scottrade's posted numbers (434,829) finally agree with those posted by North40000 et al ... they were, however, way off for over an hour (Scottrade was showing over 1.15 MIL shares traded and local broker couldn't explain why during my phone query. It didn't really matter to me as I was not buying (and certainly not selling) but a notably odd occurrence.