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You go louieblouie, Hope you re-retire soon a wealthy AMRN investor. I retired a year and half ago after 21 years of a 76 mile commute driveway to parking lot. 12hr. shifts and 14 days a month with special projects quite often. Get out as soon as you can and spend your re-retirement with family and doing the things you love. I occasionally talk to old co-workers telling them I miss them but I'm not coming back to work to see them.
Good luck
That just about wraps it up, concise and cohesive.
"All in"
Regards Jakey, Saw the ad, thought it was a decent ad. Just wondering though why the worry about Rick Harrison, I believe his name is of Pawn Stars. Thanks for the post!....GLTAL
Thanks for the eloquent cheer, you also saw that the pom-pom girls were kinda in a dark mood as if we had lost the game!
A very fair synopsis JL, Thanks.....waiting not so impatiently, but waiting none the less.
Sam81, you know how much we all look forward to your posts, how could you let us down. Damn work always gets in the way! We will get by, you have a good weekend buddy and don't work too hard!
Thanks Sam81, you drive my Fridays. Keep up the charge!
VuBru, couldn't AZN sell Epanova in this scenario with license to sell to another competitor if they owned Amarin patents?
BB; You are saying you want to see an 8K advising a label change but as I discussed with STS, that while a label change is preferred the FDA conceded to AMRN the right promote off label which might work very well in this instance in lieu of label change at least to my way thinking. Btw thanks for all your efforts as well as LB's in getting in the FDA's butt, keep up the good fight my friend!
Sts; Do you suppose that this could lead to the off label promotion as allowed by the FDA for this OB'd patent along with any other supportive studies that may exist, and although not a label change it maybe the next best thing?
Thoughtful post F-guy, I have been thinking along similar lines. I don't know though if the data points of the second interim look would or possibly could have much relevance for the first interim look. Maybe another poster has that information. G.L. to you
Have a great weekend Sam81 and thanks for what you do!
Sam81, I can't Thank you enough for providing these numbers to the board. You are a "must read " every Friday, Thanks again.
BB, I think you completely overlooked the effects of an escalation of script sales. If and I suspect they will, as they are now, script sales (Thanks Sam81) will dramatically increase which will bring notice as well as a better financial situation for the company and value to the stock. It just does not appear that dire a situation from where I sit and have been sitting since 2010. This picture is sweetening up!
Fish, I think, it certainly would be the most advantageous time to again go after the FDA for the rescinded SPA. New science abounds, as well as a new head that is a cardiologist who may understand the science better. In my view continuing the fight through the hierarchy of the FDA would both demonstrate our willingness to correct a wrong with them first and not present ourselves as a hostile enemy (as they implied in the 1st A suit) and like wise show ourselves as a tenacious company who just may take legal action against them again if they get it wrong again. And as Woodcock has said "come to us first". A thoughtful successful action here would open the floodgates and may only take another focused effort.
BB, Imho, this would probably be a very good time if not "timed out" for Amarin to restart the upward march through the FDA hierarchy to reinstate Anchor for a couple of reasons. Firstly, it would signal to them that we are not content to allow their past mistreatment or wrong-headed decision to unilaterally breach a contract and rescind the Anchor SPA despite legalities. Secondly, Especially, in light of overwhelming new science that shows high triglycerides are linked to CVD as well as implicitly demonstrating a willingness to cooperate with the FDA's structured appeal process once again in their "Mother, may I" come to us first requests for those wanting to appeal. All the while demonstrating willingness to take this action to court if necessary. Maybe with the new leadership this may be looked at with a different urgency and science will be considered.
rosemountbomber; While it is true we really don't know how this will turn out, we have very strong and convincing evidence how it will turn out. JELIS turned out very well. We know our outcomes trial has sicker people with higher dosages of EPA being administered so it's not to much of a stretch to conclude what the outcome most likely will be. But then you know this and despite what could go wrong and has gone wrong the overwhelming possibility is in our favor based on what we already know.
mrmainstreet; I think you're flat out wrong. Don't take this personal but I think it's pretty naive to think that after all this time, all Amarin and their legal team is doing is polishing what they can say or promote with the FDA looking over their shoulders at every word saying "that's ok" or "that's not ok". If that's what you think then you probably think that the FDA won the preliminary injunction. Amarin is no longer the nice guys you think as proven by them taking the FDA to court not once but twice. Please don't be foolish enough to drink the Mogwai Kool-Aid, if Amarin is not given something substantial this will be going back to court for more than just first amendment adjudication.
Robin; Amarin may be asking for more than some expect, certainly not more than they deserve and there lies the conflict. This may be heading for court, hopefully, the FDA is not that intransigent if so it will be to their substantial loss.......pay me now or pay me more later. We'll see soon!
If you mean taste, hope you mean pea and if you mean pee I hope you mean task. Couldn't resist, damn spellcheck....keep up the good work and ignore the haters, love you man!
isaeed; Could be, '....And so, with regard to your specific question as to whether we're looking to re-implement the SPA or to get a label expansion, the short answer to that is no. ......' but negotiations are underway for a new SPA and approval of Anchor under way in this new negotiated SPA. This would make JK'S answer truthful although misleading but not revealing. This could also explain why our attorneys are on board with the time extension.
Mercator; Excellent post, Very well stated and I also agree with you 98%. From my belief the FDA has very little to bargain with, now that's not to say they wouldn't try. I just think that with what has been documented in court transcripts, the Adcom, significant science, promises of further litigation among other things Amarin's attorneys are driving things thus the requests for more time from our attorneys. The extended time is slow governmental bureaucratic red tape. While I don't believe as yourself, that this has anything to do with early peeks for Reduce-it, they could be getting i's dotted and t's crossed so there is not another gotcha if an Adcom is needed for the Reduce-it indication. My understanding is Reduce-it is a third indication and market and thus failure, on the slim chance it would occur has nothing to do with the "very high Triglycerides market" which is the Anchor indication. I am opposed to anything that would jeopardize the sanctity of Reduce-it but if Amarin would allow that, I think they would do so only if it would make sense from a strategic point of view and only under advisement of their very capable attorneys and I would not be so quick to sell my shares although my finger would not be far from the trigger.
Good luck to us longs.
Marzan; That question was pertaining to the Anchor Adcom for the high triglyceride (200-499) indication a different indication than Reduce-it.
JL; Hilarious, LMAO, I keep thinking of this even fifteen minutes later. Classic.
JL; Firstly, thanks again for all you bring to this board intellectually.
While I agree with your line of thinking in general, I do not see the need to reinstate the SPA. Would this mean another AdCom? Why even prolong this that much more when the sixty days they have requested is in my opinion enough time to review the new science and address concerns they might have with label language. This along with as I recall that the FDA really doesn't need an AdCom as this is not a new and unknown drug (Vasepa for the Marine indication has been on the market for a while) and they could move expeditiously to an approval and expansion of the label. I would think that Amarins legal team would want to move as expediently as possible. Maybe I could understand the SPA if that wrong needed to be righted from some legal standpoint but other than that why bother. I don't wish to rush the best outcome for us but on the other hand I don't want unnecessary time wasted.
Zu; I also wish to thank you for the never ending scientific information and even though I don't understand most of it, some I get and all of it I appreciate.
Thanks.
There must be something awfully contagious going around, It has been contracted by some of our best and most talented posters. I can't get a handle on what it is we need JL's expertise for that. Whatever it is we need to eradicate it. A lot of us don't have the stamina, we need a formidable personality with the perseverance of Will for that. Although as powerful as this thing may be and even though individually it may be able to take us all, collectively we can take it down. Stand together for the good of us all. Let's toast in Las Vegas
Zumantu: Excellent post, of the many excellent postings written here by many bright people this post has earned it's place.
I would imagine the FDA is starting to see the writing on the wall. They probably and rightly so can see and fear a changing of their house as they know it. Congress needs to restructure the FDA so this kind of thing cannot happen again.
Invest: We may find ourselves pleasantly surprised fairly soon as a result of the "settlement talks" underway now between Amarin and the FDA or at least the road forward if these talks fail. Quite possibly Amarin will seek label expansion AND a monetary settlement that the FDA finds both hard to swallow and equally difficult to dismiss. This is a quandary of no small matter caused by their own arrogance and stupidity.
Taking this a bit further, if there is a monetary settlement, how best could this money be used to increase shareholder value, i.e. Paying off loans, buying back shares, marketing Vascepa, or any other ideas?
HDG; It is my belief that the NCE case is all but in the books as far as Amarin,the FDA and the courts are concerned. At this point any further litigation concerning Watson is side noise which will be addressed as another issue even though related, but should not preclude OB admission of Vascepa's NCE. I do not think FDA's legal team would allow or advise the FDA to withhold this OB entry and risk the ire of the Court of His Honorable Randy Moss. He did not think highly of their earlier antics with respect to Amarin's treatment at their hands and this OB omission would further test his judicial temperament should it come to his attention.
So what does the past court actions say about the FDA'S rule on appealing through the levels of FDA hierarchy before suing in court and other such items of horse shit?.....sorry Bull pucky?
invest; I also think it would be a good idea to go to J.W. "first" with "truthful and non-misleading" information about Anchor,JELIS and the subtle hint of another law suit to negotiate the recission of the recission. Lets hope she might be in a more conciliatory mood. We just want what is rightfully ours.
drrc1949; I can do you one better, may we have the "life" we deserve and may Vascepa make us healthy and wealthy. Best wishes.
drrc1949; been here since 2010 and have added continuously since, be it up ($14.00 (sold some at $16.00)) or down ($.87) most recently bought more at $2.18. This to illustrate that I may be foolish but certainly not bashful. Thanks to all who contribute here including those who ask what may appear to others to be foolish questions.
ggwpq; Thanks very much and best wishes, this should change the game for us. This quite possibly could lead to a more serious look at who Amarin is and what it has to offer by those searching for the next blockbuster!
Raf; I think you may have meant "apprehensive" in your last paragraph, first sentence instead of "comprehensive".
Thanks for your thoughts.
Sts; Amarin filed suit in federal court against the FDA for the right to use truthful and non misleading speech in promotion of Vasepa. Freedom of speech as allowed by the 1st Amendment of the Constitution is prohibited by the FDA with respect to off label speech. In addition to this,they are seeking a preliminary injunction to allow them to engage in this "prohibited" speech for the off label promotion of Vasepa which is prohibited as well by the FDA until this case is adjudicated.
Sorry if this appears overly simplified but this kind of simplicity helps me understand things abstract to my way of thinking.
My thinking is that while winning the injunction will help pps moderately,initially. What it does more importantly is give us a David like appearance that would garner press for the fight against Goliath and thus needed exposure. This in turn helping us in terms of being more visible and accepted by hospitals and Doctor's offices to hear truthful and non misleading drug promotion and thereby increasing sales and value. This building of market share and value leading up to RI.
Will; In this context couldn't AZN sell Omthera and having purchased AMRN, they could give or sell a license for the distribution rights of Omthera since they would then also own the patents. This would justify the awkward purchase of Omthera with the knowledge of Amarin's patents also this might help offset the multi-billion purchaser of Amarin.