"We have completed our review of this supplemental application. It is approved, effective on the date of this letters for use as recommended in the enclosed, agreed-upon labeling text."
As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(1)] in the structured product labeling (SLP) format......bla bla
Signed by Eric Coleman and call Kati Johnson for questions...
Someone verify and clarify what's going on?
One other stupid change where they put the trademark. I guess they where just practicing for adding something of significance. What a waste of time!
Folks this is a label confirmation, right? Typically not a negative event. You might want to wake up from your nap.
Anybody with a brain want to confirm my statement. We have action of some sort good or bad?
Not really sure what's going on but Amarin appears to be quiet.
It's more than strange that the two Cholesterol Expert groups NLA and ACCE didn't put their names on the guidelines.
The ACC and the American Heart Association (AHA), in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) and other specialty societies, released four guidelines focused on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults.
These four prevention guidelines were among five initially commissioned by NHLBI starting in 2008 and transitioned to the ACC and AHA in June 2013 as part of a collaborative arrangement to facilitate their completion and publication. A fifth guideline addressing hypertension will be initiated in early 2014. Each provides important updated guidance for primary care providers, nurses, pharmacists and specialty medicine providers on how best to manage care of individuals at risk for cardiovascular-related diseases based on the latest scientific evidence.
NLA Statement on the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults
The American College of Cardiology and the American Heart Association released the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. The National Lipid Association (NLA) was invited to participate in this process and worked initially with the NHLBI and then eventually with the AHA and ACC as the guidelines were transitioned and finalized. We provided our comments but after multiple revisions, ultimately felt that the document presented - although important and constructive--does not go far enough to address gaps in clinical care and therefore decided not to endorse them as guidelines. We understand the constraints that the NHLBI panel had in limiting their review to only high quality randomized controlled trials but also believe that other important types of clinical evidence should not have been excluded. We also do not find evidence-based support for the Panel’s recommendation for removing LDL-C (and Non-HDL-C) treatment targets. We question the need to remove such important and well-known clinical performance metrics that have been so widely endorsed by the clinical community. Further we find there to be an absence of discussion regarding other therapeutic options for patients on high-dose statins but which still exhibit high residual risk and/or significantly elevated LDL-C levels. There also needs to be more discussion on managing special populations such as older patients above age 75, those with familial hypercholesterolemia, those who are statin-intolerant, and younger high risk patients under age 40.
The NLA understands and appreciates the considerable effort and professionalism that went into creating this document which should serve as an initial focal point for ongoing discussion. We have been invited and will participate fully in the next phase of guidelines development with the AHA and ACC, along with other stakeholder groups, to discuss further implementation options and considerations. Our goal is to contribute our vast expertise and experience to the next set of guidelines so that clinicians can better and more comprehensively manage their patients in both primary care and specialty practice. The NLA looks forward to a continued collaborative partnership with the ACC and the AHA to enhance these guidelines in the next phase.
Here's a quote from the intro of the new 4 guidelines:
"The Expert Panel acknowledges that our process did not provide for a comprehensive approach to the detection, evaluation, and treatment of lipid disorders as was done in the prior ATP III Report (6). However, these guidelines were never intended to be a comprehensive approach to lipid management for purposes other than ASCVD risk reduction. A limited number of expert opinion recommendations were made only when RCT evidence was not present and after a thorough consideration of what the Expert Panel had learned from the RCTs. For the many questions regarding complex lipid disorders that are beyond the scope of our systematic evidence review, or for which little or no RCT data are available, it is anticipated that clinicians with lipid expertise can contribute to their management."
Bottom line, the only scientific changes are in the opposite direction the FDA insinuated. 2013 AACE guidelines recommend "aggressive treatment" including treatment of Trigs 150 mg/dL and "very aggressive treatment" for those with a history of a prior coronary event and Metabolic Syndrome. These treatments include the use of "Ethyl Esters of Omega 3" and caution DHA may increase LDL. The 2013 AACE statement specifically mentions EPA only. The "new" 4 guidelines only include reviews of studies through 2011 and will be updated again in 2014.
The FDA is in a deep, deep hole...and I'm ready to start pushing the dirt in.
We must find Attorney connections with SEC & FDA experience. Anyone have any contacts?
Before you take my Twinky you'd better show me the outcome study!!!
I do believe I can comment on this. Today the FDA has delayed Amarin exclusivity, USPTO patent extension request for well over 1 year. Combined with the shame Lovaza CP, I do believe we have a great Antitrust lawsuit. Just need to figure out who John Fuson, ex FDA lawyers, client. The FDA knows...they've collaborated with them to impede Amarin every step of the way. Questions?
For the bleeding to stop we must take out one BP with CP, requesting 10 year sanction from All marketing based on Criminal Convictions and Federal Law USC 21. GSK is the easiest target.
Amarin and most longs have no idea what's going on:
The FDA is a Corrupt White Collar Organized Crime Syndicate, I've been telling all of you this since the December 2012. It became crystal clear after 2-6-2013 shame CP was filed. Now, this FDA mafia has destroyed Amarin...period. Why? Because Amarin can't get too big without understanding the game.
Here's the game with examples:
1) Pay to Play (there's the small everyday Pay to play like the $25,000 seats to inside meetings) but the real pay to play are large fines charged to BP for "Crimes"...(after they pay or before) depending on the trust level of the BP FDA relationship and past history of Quid Pro Quo.
Example: Janssen's very dangerous diabetes drug gets approved March 29 , 2013 with clear signs of Cardiovascular risk, higher than the FDA was willing to accept. Mary Parks MD, pushed it through with a postmarking CVOT. Janssen settles with the Justice Department for a long pending case for something like $1.2 Billion dollars. These are related and Quid Pro Quo.
2) Out right Antitrust violation using CP to delay generics, sometimes just to delay them enough to get a new patent or some other advantage. Nonetheless, it's a violation of US Antitrust laws. GSK has lost these suits and I have posted them in the past.
So what can you, we, Amarin do about it? First acknowledge the rules, they are criminal but not enforced because this is part of the White Collar Government Mafia "club". If you don't believe me and understand me...Dec 20 the will be too late.
THE PLAN:(We can fight legally and in a public forum)
1) We must gain legal support and retain a kick butt law office that isn't afraid to mix it up with the FDA and DOJ
2) Goal is to get Vascepa approved fully with a SPA that is not justified to break
How we fight?
Utilizing USC 21 Government law and prior Big Pharma convictions we can selectively request the US government to sanction Big Pharma that have been convicted of crimes. Take your pick, GSK (Antitrust, Federal crimes convictions for Marketing (paid fines), Bayer, JNJ, AZN (with holding safety data, also punishable)
By law, any company that's been convicted or withheld studies showing drug safety danger, the secretary (assuming HHS or DOJ) can sanction Marketing of those company's prohibiting ALL marketing for up to 10 years. This is Federal Law USC 21.
Requests can be made to the Secretary via Citizen Petition, the Petition must be responded to. We can withdraw the petition if "we change our minds".
I'm gonna start with GSK, since they've been convicted of so many crimes and China is in the news so frequently. Perhaps if GSK could find it in there hearts to help Amarin out I would reconsider....
This is the "game". Leverage, threats, and abusing the legal system of the USA...anyone want to play?
We are going to lose if you don't know the rules....I've tried in my "crazy" rants to show you the game...wake up or Amarin is done.
Any contract Attorney's that could work on a joint White House / Department of Justice letter?
while under normal private contract terms a company can be sued for threatening to breach a contract. It is however, a completely different circumstance when the FDA does breach a contract. The party has to exhaust grievances (type A) meeting, then file in Federal court. I'm hopeful when we do file Amarin values the damage based on share count and called margin damages. The FDA is looking at paying out multiples it's budget. This is also a reason why "we the people" should be contacting both the White House & Justice Department, perhaps they can get the FDA to see their judgement error clearly.
Include the new meta analysis and send your warning on. I have a more general warning, but it's a little harsher.
"While the FDA is charged with approving drugs to improve your health, we on occasion get egomaniacal and refuse good drugs to market out of spite. This helps us maintain good pay to play relationships with corrupt Big Pharm., they have great breach house "rentals"."