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Somebody better tell Dr. Oz about the new treatment guidelines!! He still thinks you need to treat TGs over 200mg/dL. Better call the AHA and the FDA right away!!
DeepBreath, BioChica, zmanindc, rsquirrel,
The Initiative has a website: www.epadruginitiative.com with a Contact Us link. If you have suggestions, something you want to see published or if you want something from them, go ahead and make contact; I think they'll respond quickly.
DeepB, thank you.
DeepB, that's a good move, which list did you work from? I want to send something personal to each of them as well. It's hard to keep up on everything so sorry if this has already been published but is there a House Committee that also has oversight of the FDA?
JL and DBreath,
If that's possible (and anything is), then the only way to really go at this is to cluster bomb the entire Senate and House of Representatives with our "factual" allegations. There have to be some honest people with integrity representing us and we need to ferret them out. The initiative has the right idea, we have to build political pressure on the FDA but we also need to put the information out to the Medical community in the hope that we can generate scientific backlash.
Not that he doesn't have other things to keep him busy, but maybe this would also be a good time to push this all in front of President Obama's Team and try to encourage someone there to make an inquiry. "Peggy" certainly had awareness of the extent of FDA corruption when she took the job as Commish. Maybe we can get a "rise" by letting them all know we remember 2009 warnings.
Doesn't work because it is inhibiting Lp-PLA2 at the wrong time in the wrong place! Needs to operate in the natural cascade process of the inflammatory response. Lp-PLA2 is an effect not a cause of the inflammation that destabilizes ahterosclerotic plaque. Tough nuts Glazo.....('<
Epanova Trial: Sounds Like ANCHOR to me.
Main Inclusion Criteria:
Fasting triglycerides 200-499 mg/dl
Non-HDL-C > 130 mg/dl
Stable statin treatment
Exclusion Criteria:
Type I diabetes or uncontrolled type II diabetes
Recent cardiovascular or coronary event
History of pancreatitis
History or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data
Uncontrolled hypertension
Mid to Hi 2s....well that's pretty encouraging!! NOT (lol)
Not very long ago, I was congratulating myself on having successfully averaged down to 6.30/shr by writing Calls, buying and writing Puts and trading in and out of the stock. And I thought I was pretty well positioned for the AdComm owning Calls for Dec and out to Jan 2015 from strikes of 6 to 10. Holding a little over 500 Calls and 24K shares. Should have taken the blinders off but I didn't. I'm kinda shell-shocked just now so just watching developments....it's a mess!
Yeah.....about those earlier comments of mine porgyrusty, ahhh....it looks like I may have misspoken. As it is, I would probably have reneged on the bet since I have very little left to payoff with, but I would have laid a sizable amount that I was right. I was totally surprised by this outcome but you were right on the money! I would have done well to take your advice. Hope you made out on it and good luck going forward!
nelustar, where can you be reached with E-mail?
That would be great Ajax. And as goseek just pointed out, I completely agree that if the FDA took any approach that approves the Vascepa label for Trigs of 200-500, everybody could be satisfied.
But the FDA won't do it! That's the end of it....period. Why won't they do it? That question has kept me awake at night! Because the FDA can not tolerate a paradigm shift in the treatment of cardiovascular disease in the USA. That would be an existential threat. The FDA has long-standing relationships with all the members of the BP club. (In politics, it's called cronyism). The FDA consists of Bureaucrats and if there is one thing bureaucrats know....it's where their bread is buttered!
Amarin isn't a member of the BP club and so it has no allegiance. What it has is a drug that could have the same impact on the Pharma industry that a terrorist group with the "bomb" would have on the existing world order. Possession of that drug by Amarin, with all that benefit it may bring to healthcare in this country...and the rest of the world, is not an acceptable option to the FDA. If they gave Amarin free reign to market Vascepa, that would be the start of a massive power shift in the industry....perhaps away from cronyism! The FDA can't have that happen.
Please don't misunderstand this, the FDA absolutely wants Vascepa to be successful, but in the hands of one of its cronies.....not in Amarin's. The FDA has other plans for Amarin, they want Amarin.....Dead!
IMHO, I'm disgusted and I'm drained.
You're a very funny guy David Fowler! Well, I hope you scored on this event, you've been on the right side of the trade for a long time. Sorry I wasn't there with you but I do still believe in the drug....if not the company. Good luck.
If there is any silver-lining here, I think it is that the focus of efforts from this and other boards has just been crystallized. The best short term expectation is compromise labeling to be negotiated between FDA and AMRN in a Type A meeting.
If that doesn't result in a positive outcome, then the Courts must be utilized to obtain any form of remedy. I still don't see how they can justify this position regarding the SPA contract but.....
I'm curious how you determined that 200 events had taken place to this point. Can you say where that information is published? Thanks!
So you're saying the "deer in the headlights" stare from our team was really a clever subterfuge to mask the genius master plan they'd been preparing? Ahhhhh....now I get it!
WM, it's not necessarily true that cost savings with Vascepa aren't immediate. I recently detailed two personal incidents on this board in which my underlying coronary condition was responsible for an exacerbated inflammatory reaction that caused me to be hospitalized. The actual amounts paid by my insurance after contractual discounts was over $33,000 for the first incident and over $37,000 for the second. Since beginning treatment with Vascepa, the symptoms which led to these hospitalizations have been vastly improved and I am hopeful that I can avoid future events. 70 grand buys a fishload of Vascepa.
It is damn sure worth a try! There's a bit of the problem, JL. If AMRN management gave us any insight into what they are actually doing to help our cause, there might be slightly less frustration with them, slightly less anger.
bobjones2731, I just read your post. It seems that in fairness I should allow JZ a little space to maneuver (see my post #19515), but I really FEEL like responding to your post with one word......DITTO!!!
Yoyo, just about anyone who's followed these developments between the FDA and Amarin would echo your thoughts. Personally, I am completely shocked and dismayed by what appears to be deliberately damaging action against Amarin. It raises a host of questions in my mind that are incredibly frustrating because the potential answers just don't seem plausible! I'm not naive but the FDA is supposed to serve the public good. We'll see how some of that resolves over the next few months. The importance of efforts being made by many on this board to spread the word and support our case for Vascepa can't be overstated and it has to continue. Thanks to all of you!
I'm waiting, quite anxiously, for the Earnings Report and CC from our management. To date, I've not been impressed with their skills in representing our interests during any adversity....not impressed at all!. I believe it was a post from "annac" on this board that summed it up quite clearly, this team has poor social skills. They've consistently failed to rally any kind of support when trouble has knocked on our door. Instead, they've barricaded themselves inside their "cone of silence" while the value of the company has wasted away. I'm hoping to see a change! A real action plan....something with teeth in it! A sense of urgency....12/20/2013 looms closer everyday! And a commitment to us....the Shareholders...tell us what we need to know!
If they can't figure this out, then they will have lost my support. If that happens, I place them in the same camp as the FDA....the enemy camp. My future actions will be determined in accord.
Zu, you're a gosh-damn wonder man!! This is really a super compilation of Vascepa and AdComm information! Thank you for your efforts.
Speed, your letter is an excellent presentation for the powers that be at the FDA. It argues a very legitimate case for Vascepa. I hope you don't mind my suggestions (below) for a few minor editorial adjustments.
As a side note, I'm under treatment for ideopathic cardiomyopathy since 2002. I've had gastro problems for most of my life and feel like a lifelong adherent to proton pump inhibitors. Bowel symptoms have remained prevalent as well. Four years ago and again two years ago, I was hospitalized under emergency with ischemic colitis, first for nine days and next for ten days. Treatment with intravenous CIPRO and FLAGYL and DILAUDID for pain was successful in suppressing the infection. Each time I avoided re-sectioning of the colon. I always thought my heart would eventually kill me but never anticipated it would take this course....it's pretty scary.
My point in all this is that several years ago, I began learning about Vascepa as a TG lowering substitute, Lovaza was always difficult for me to take with awful eructation and bouts of dyspepsia. But over time, I began to understand the anti-inflammatory properties of EPA as well, so when Vascepa was approved, I bullied my Cardiologist into prescribing it for me. Here's the good part.....since initiating treatment in March, the frequency and severity of many of my bowel symptoms has decreased significantly. Random bouts of stomach and intestinal distress have lessened dramatically. Most importantly, my fear of dragging myself to the ER with the prospect of never leaving is beginning to wain....a little. I'm not calling it a miracle....but I do believe Vascepa is the agent at work. Maybe it can help some of your patients.
Your Letter:
"I am an academic center based gastroenterologist who specializes in both clinical practice and research related to obesity and inflammatory complications. With our current epidemic of obesityxxxxxxxxx, cardiovascular disease (CVD) remains the number one cause of adult mortality in the US. Although statins have had a major impact in improving CV outcome, risk of CVD remains high for many patients despite being on statin therapy. Previous studies have shown that elevated triglycerides (TG) are an important independent risk factor for CVD and that patients with elevated TG are much more likely to have complications related to CVD. Current recommendations of major medical societies including American Heart Association (AHA) and American Association of Clinical Endocrinologists (AACE) are to treat elevated TG levels above 200 mg/dl. The most recent guidelines published by the AACE in 2012 xxxxxxx state that “increasing clinical evidence suggests that elevated triglycerides may be an independent risk factor for CAD; therefore, AACE recommends screening of triglycerides as a component of lipid screening” and target “ triglyceride levels less than 150 mg/dL in both men and women are recommended (Grade A)”. Both AHA and AACE recommend treating triglyceride levels of 200-500 mg/dl with TG lowering agents “including omega fatty acids”. The current standard of care management strategy dictates that high risk patients with elevated triglycerides (200-500 mg/dl) be treated with TG lowering therapy.
Recently completed clinical trials (Marine and Anchor) have shown icosapent ethyl or vascepa to be highly efficacious in lowering TG in high risk patients with TG levels above 200 and 500 mg/dl without raising LDL-cholesterol levels. Moreover, the safety profile was excellent and favorable to other currently approved agents for lowering TG. Based on the published clinical trial data, vascepa has important therapeutic advantages over other currently approved medications for management of elevated TG levels in both safety and efficacy. Given the current recommendations by the major medical societies and the compelling data showing TG to be an independent risk factor for CVD, I urge the FDA to approve vascepa for treatment of TG between 200-500 mg/dl as the best drug in this class (best safety profile without raising LDL-cholesterol).
I would also like to express concern about the recent controversy surrounding the FDA advisory panel vote on the Amarin sNDA submission and the possible FDA decision to break the special protocol agreement (SPA) with Amarin. Amarin has fulfilled all aspects of the SPA in regards to the Anchor indication and sNDA submission. However, based on the xxxx voting question presented and comments made, the FDA seems poised to breach the SPA by imposing a new requirement before granting sNDA approval. If indeed this is being considered, it would be a huge mistake for the FDA as such action could materially damage FDA’s credibility going forward. In my view, this breach and violation of the SPA will have serious long-term consequences and could discourage new innovation and high risk development of drugs by small biotech companies. The suggestion by the FDA that “a substantial scientific issue essential to determining safety or efficacy of the drug has been identified after the testing has begun” is highly subjective and certainly has not been shown to be the case. The threshold level for such determination should be set xxxx very high xxxxx and any benefit of doubt should favor complying with the agreement. There were no substantive or indisputable evidence xxxxxxxxxx presented that demonstrate vascepa reduction of TG would fail to improve clinical outcome. All of the studies presented had major flaws in the design or did not study the high TG population. The only study to use icosapent ethyl showed a 53 % reduction in CVD related outcome, supporting the vascepa approval. In fact, more recent publications showing genetic linkage studies provide compelling evidence that elevated TG levels are an important risk factor of CVD.
In conclusion, TG elevation is an important risk factor for CVD and the current standard of care is to treat high risk patients with elevated TGs (200-500 mg/dl). Based on the clinical trial results of Anchor, which fulfilled all of the requirements of the SPA, I strongly urge the FDA to approve the sNDA for vascepas use in treating patients with elevated triglyceride levels between 200-500 mg/dl."
May I suggest slightly different wording for the following passage in your letter to Dr. Hamburg at the FDA....
"This is troubling, because Vascepa because of its proven anti chronic inflammatory properties has the potential for prevention in many chronic diseases which chronic inflammation is the underlying process and diet seems to be the driver.."
might be altered to.....
"This is troubling, because Vascepa with its proven anti-inflammatory properties has the potential for prevention of many persistent diseases in which chronic inflammation is a causal factor and improper dietary intake appears to be the primary driver..."
This letter is a very well constructed and informative position statement being made to Dr. Hamburg. Hope you don't object if I plagiarize and paraphrase?
Sorry this got you riled up JL, I was responding to ranjo post# 19157
Have you seen this study on Statins and EPA?
http://www.biomedcentral.com/1741-7015/11/5
Connecticut?
Script Numbers for last week.....has anyone seen the published totals?
Oh and BTW as "Dancing" re-references in Post 19019, who really did change the Anchor labeling for the AdComm and why the hell didn't management either prep for it or fight it? Oh right....it's that balls thing again! Absolute bullshit!
Given all of the circumstances, if Amarin CAN'T swing something close to an amended label to include Diabetics with Dyslipidemia, then we really do need to start looking at replacing Senior Management and current Legal Counsel. Maybe it's going to take some skills that our executive team lacks. They've done a stellar job advancing the Company EXCEPT when they've faced any type of adversity. Think back over the last three years and you'll agree that these are a group of "fair weather" managers, they do not deal with threats of any type instead they "circle the wagons", group themselves into a little cluster, declare a "communication blackout" and do NOTHING. No rebukes, no defense, no Plan B's, no explanations and no balls......I've got a feeling that course won't work any better this time than it has in the past. It's over a week after that abortion of an AdComm (shame on both sides) and so far.....they fired the income generators. Really.....great, that couldn't wait until PDUFA?
Oh my God, you have finally lost your minds completely. A primary emphasis of the Affordable Care Act is preventive medicine. Vascepa is preventative medicine! Any poster on this board with a brain knows that Vascepa usage could eventually result in billions of dollars in savings on healthcare costs. How can you possibly entertain the idea for even a nanosecond that the Obama Administartion is trying to save money by not approving drugs like Vascepa? Stop posting here and call Fox News, right away!
I'm sorry....but when you say "talk to Amarin", is this something that's just going on in your head or is it a real conversation? I gotta tell ya', the last thing I want to hear on this MB is little teaser comments followed by imaginary discussions. Haven't we gotten our fill of that from JZ?
I don't intend to comment on the efficacy of Vascepa in improving the appearance of the skin in your abdominal area, I'm merely going to point out "You go girl!!". I might also mention that I am an adult male. LOL
Error 404 when I try to open 74 day letter posted by Louieblouie.
I happened to see a message that was quite an eye opener for me! Actually there seem to have been 2 of 2 (missed the 1st one until this evening) that I've now had a chance to peruse. I am somewhat surprised as well as disappointed....I thought the other side was the dark realm but seems it lurks in many places. I can certainly empathize with any situation that hasn't gone well.....I've taken a big hit on my end over the last 2 1/2 years....quite painful actually. It'd be my pleasure to do whatever can be done to help end this turmoil....let's see what that might be.
I think it serves no useful purpose to carry on with that activity, just causes grief all around.
Yeah but did you note that Wile E. Coyote always survives to track another day......I say that Amarin will do the same!
You know JK29, that's really great but I hope that Joe is planning on having a lot of communication between Amarin and it's owners (you know...us, the shareholders) between now and Dec 20th. I for one have grown very tired of the perpetual information blackout imposed on us by our company's managers. I say, cut the BS and keep us informed.
Nice presentation, Zu....simple, to the point, get it on the docket if it's not there already. Have a good weekend sir!
Look on the bright side Grant, a 1% burst upward!!
They're all in a GIANT funk and don't know where to turn or what to do. I definitely empathize since I wasn't immune from the recent ass kickin'. Do you really see the FDA approving the Anchor sNDA?
They (FDA) obviously screwed up the process in a number of different ways. Banging on safety concerns and then conceding that's not an issue, no notification on bringing in new science but then slamming the panel with it, an absolute joke of a vote, hell half the panel didn't seem to know what they were voting on and finally, the ramifications on the rest of the industry! Do they think they can just screw AMRN and keep it on the hush-hush?
I'm having some trouble getting past the stink of "vested interests" (read BP) all over this AdComm and the frustration with that is nearly overwhelming. That's what's happening on all the boards, probably be calmer on Monday. Have a good weekend!