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Good Evening ALL, I posed a question a few days ago and I'd like to try again.....does anybody know which Patent Claim would be infringed by Omthera/AstraZeneca bringing Epanova to market?
Not much really......just the things that actually matter, EPA/AA, Triglycerides, other Inflammation Markers. But hey now, let's not be nit-picky! One day, the ACA will figure it all out.....really, no they will...really........??..
Not today "freak", not today.....
What is the actual Claim in the Vascepa Patent that would be infringed if Epanova is brought to market by Omthera?
Delayed decision for another month. The FDA has no Conscience, the FDA has no Morality, the FDA really has no Reason for Being. It should be dissolved this evening as it serves no useful purpose except to remind the American public of the corruption that is rampant throughout our Government.
The FDA failure to make Vascepa more widely available takes a greater toll as a percentage on the US African American community than any other population. Type-2 Diabetes and its complications are an extremely serious problem and Vascepa could really make a difference if it were available. This information needs to get to media savvy people who know how to fight injustice like Al Sharpton and Tavis Smiley. Then the case against the FDA should be placed in the hands of members of the Congressional Black Caucus, that would get the bureaucrats off their behinds!
IMO, should the FDA not reinstate the SPA or take some other conciliatory action with Amarin, then the company must rise up and act to overcome further delays. This becomes a fight for life and Amarin must authorize their Sales Force to provide information to Docs based on Clinical Trials and other peer reviewed evaluations. It's the proverbial "straw" and it must trigger the start of the 1st Amendment battle. If the Amarin Sales Force provides honest 3rd party information about the benefits of EPA, the Courts have ruled that it is allowable free speech. If the FDA wants to fight Amarin on this, then I say let them go for it....let's see how that plays out in the Media, the Congress and the Courts.
That may all be true but I think the author makes a decidedly strong case for the actions that John Thero SHOULD be taking NOW!
I guess developments such as these do not bode well for Amarin. If algal culture enables production of an essentially unlimited supply of EPA, then our primary barrier to entry is removed and the door is wide open to competitors.....especially those who won't be visiting the FDA for permission to introduce a new drug. As word spreads about the benefits of EPA, GNC and others are in for a raging bull market!
Gabor, you are a breath of fresh air on this board. With the treatment that Amarin/Vascepa have received by our public watchdog, the FDA, at times I find myself nearly unable to engage in rational thought on the issues present. It is at these waypoints that your well informed, non-emotional posts help to keep me in check. Thank you for your deliberation and insights.
CaptBeer, I added my 2-cents to your CP. And may God damn those who are corrupt at the FDA, they are no better than cold-blooded killers!
Interesting TIME Magazine cover story in the June 23rd issue - "Eat Butter. Scientists labeled fat the enemy. Why they were wrong". Brian Walsh has done a credible job of presenting the current science (as far as it goes anyway), including the failure of existing dietary guidelines to positively impact on heart disease. He points out that they likely missed the boat when the AHA et al accepted a flawed premise that Fat intake is the problem. He cites new thinking that the real problem is excessive carb intake as the true cause of obesity, the culprit in promoting insulin resistance and the likely predicate for heart disease. He mentions the role of Triglycerides, LDL-P and (not his words) the A-Holes who control the scientific media.
He stops short of any discussion of EPA vs AA but he walks right up to that doorstep. I'm going to find a way to use this "popular" venue to add some really "new science" to the discussion he's initiated. I need to goad him into deeper investigation of exactly what's going on at the FDA today and the truth in the benefits of EPA. Pray that I'm able to develop a cogent argument in spite of my daily statin dosage and wish me luck!
It's just unfortunate in the extreme that the FDA doesn't consider the patients from these studies or perhaps even the investigators themselves to be 100% compatible human equivalents of the population that the FDA has jurisdiction over. JELIS anyone?
Thank you for the analogy ziploc_1, it fits perfectly!
Actually BioChica, one of the significant problems here is that AMARIN has been primarily focused on Triglycerides rather than Inflammation.
The truth is that they've been privy to more than three (3) years of education by members of this and other expert boards demonstrating that inflammation is the problem. There have been more than ONE HUNDRED studies, many posted by Zumantu (thank you!), that illustrate how Vascepa works at a metabolic level that includes, but is not limited to, reduction of TGs (these have all been forwarded to Amarin). I wonder when or if ever Amarin could be expected to learn SOMETHING....AND ACT!!!....instead of allowing every other "johnnie-come-lately" to steal the thunder!
It's an outrage and I've probably stayed involved way too long to still remain objective. JZ was a paper tiger, JT is a neanderthal....he sounds like one anyway. Wonderful representation at Jeffries.......again.
I have read Bruno's comments and they were in response to questions raised by a poster named John King. King naively confused the response from Bruno and emerged as a vocal poster stating that FDA would have approved Anchor if "only Amarin had just asked for lowering high triglycerides just as they did for Marine". This was not the context of Bruno's discussions with King but no one ever bothered to take up a challenge to King because we were all still shell-shocked by the FDA decisions. There was never a claim by Amarin that labeling should state that Vascepa lowers risk of CVD - END OF STORY - PLEASE!!
There has never been proof offered that Amarin did any such thing. Please stop slinging this pile of bullshit around until you have something more to offer.
OK, OK !!! If freak is agreeing with me, perhaps I phrased my last comment a bit strongly! (Lol)! Nevertheless, this management has been woefully remiss in providing a degree of transparency on any level....and they don't seem to have learned anything from their past disasters. It makes my head hurt, let's see....where's my Vascepa?
Unfortunately in recent history, that "additional quiet period" crap from the company has been just that. It has only served to underscore how inept they are at communicating any sort of positive news to the Investor Community in a timely disclosure. Absolute Freaking Morons!
Thank you for pointing that out Ricardo! You're a wizard!
I think Larry8 was referring to the current Management not Sales.......and he makes a good analogy!
Sorry, can't accept that without any evidence except - I SWEAR IT'S TRUE! Although there is ample reason to question why Thero holds the position of CEO, there is no reason to believe that he refused or failed to negotiate a compromise with the FDA.
And ricardoga, greetings again to you! How is it that by now you haven't choked to death on all your meandering bullshit?
Ajax133, I have posted this comment on numerous previous instances when a claim was posited that "Thero would not compromise with the FDA". I feel my stomach turn over every time I read it but my requests for validation have gone unanswered. Where is the proof? Hearsay does not suffice! So unless you have it, please shut the hell up!
STS66, you've repeatedly made that statement about Amarin going for Reduce-It language on the Anchor label, but where did anyone ever determine that Amarin ever actually made that attempt. There were other posters on this board who, through ignorance (no insult intended), made claims that Amarin had done that but I have never seen a clear admission or independent evidence to that effect. Have you?
I'm not sure I got this, "ricardoga"....is the problem their parthener or their pipperline? I mean, either way it could be significant or it could mean nothing, you get what I'm saying? Thanks for your post!
Dave, great looking site....small typo on "home page" discussion, middle of text .....aseicosapentaenoic.....
Ajax, it's certainly possible that I missed it but upon what information are you basing your conclusion that Thero refused or, for that matter, even had an opportunity to compromise with the FDA? Not challenging you, but what did I miss?
Dave, I'll have information to add about Vascepa benefits for a variety of Digestive Disorders. Please keep us all posted on where and when we can act.
In recent years, I've experienced two significant episodes of ischemic colitis (blood flow diminished due to CHF) and have dealt with gastrointestinal symptoms similar to IBS for many years before that. The colitis begins as an inflammation to colon tissue due to cellular starvation resulting from the poor blood flow. I've also had diverticulosis for many years which may become inflammatory and might help to explain some of the other inflammation related issues I experience.
After a year of taking Vascepa at the 4gm dose, I have experienced a major improvement in symptoms and substantial reduction in frequency of onset. I will stop short of calling it miraculous, but I've become a V Evangelist to anyone I learn has gastro problems in any way similar to mine. I've had many friends and acquaintances with Crohn's and Celiac disease who've provided surprisingly positive feedback, not cures but relief!!
P.S. Trigs are at 175, not perfect but not bad.
P.P.S. I've owned Amarin stock back to early 2010 so as far as that "euphoria thing" goes, Not So Much!!!
I got very little resistance from my Cardiologist when I requested that he write me a script for V a year ago. Admittedly, he couldn't find it in his "drug index" and he prescribed a 2gm dosage rather than the preferable 4gm but we worked that out with my 1st refill. My TGs were slightly elevated and HDL on the low side but I also stressed the anti-inflammatory properties. He pointed to a lack of outcomes studies re: inflammation as causation but allowed that the safety profile was so benevolent that he was willing to prescribe...and he did!
STS, the poster whose wife you referred to re: Dialysis is Whalatane from the Bay Area.
Interesting Development - CBS 2 News in NYC about to air story about teen struck by hit-and-run driver. Recovering from major brain trauma due to administration of Omega-3 Fatty Acid - EPA.
"Well, there you go again!"
But everybody liked Ronnie.....must have been something in his inflection, I dunno.
I thought the Perseid Meteor Shower last August was pretty spectacular but it's proving to be trivial compared to the huge flaming asshole that's been posting here lately!
ANNAC, thank you for posting link to Vascepa Discount Card
Seeya' Nutso!!
I see there are a few "deleted messages" preceding mine. Must have been responses to the continuing efforts of NuttyCrackersProfessor to make himself look intelligent to other posters on this board. He may actually be intelligent but he's also biased and that makes his assertions veritably WORTHLESS. He needs to be ignored like any other fool would be!!
LDL-C and TGs DO NOT CAUSE the inflammation, the low ratio of Eicosapentaenoic Acid to Arachidonic Acid resulting from our Atomic Age diets causes the inflammation. Everything that follows in terms of Immune Response exacerbates the initial vascular damage caused by Chronic Inflammation.