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.
>$30
STS negotiation of labels is a fluid process after the acceptance of the application and 74 day letter. The "preg" 8.3 updated label is sNDA 9, we're missing sNDA 5,6,7, and 8. If not agreed on they'll never actually be posted on Drugs@FDA. Fact, within 14 days of 11-25, we'll see what number (revision/negotiation) 9-19-2013 corresponds to. The 8.3 update has zero to with the 9-19 sNDA update, 8.3 was sent by the FDA on 11-4, agreed to on 11-12 by Amarin and updated within the 14 day regulation period. 8.3 was however a prerequisite for the approval of sNDA #? Dated 9-19.
This is really confusing and took two days to sort through Amarin press releases, and tons of unrelated sNDA approvals.
It could be REDUCEIT TO it makes your dick bigger, my point was the label will change before 12-9 with sNDA 5,6,7, or 8.
My theory's are dead ass on, Antitrust/NCE, GSK/John Fuson, AZN/Omethera/Patents, Pfizer/Lipitor metabolite combo NCE, FDA criminal cartel with big Pharma....
Dead ass on
This is an example of an expanded label "supplement approval" letter, it goes into detail about the changes. Amarin's "supplement approval" letter is very vague and refers 9-19 sNDA. More than one governmental agency designed this letter.
The example:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022128s002ltr.pdf
-----------------
Peace out..... this could be very good or could mean nothing...only those with 9-19 sNDA knowledge know what's up.
I'm simply saying this acceptance letter is the 9-19-2013 sNDA. It could be full REDUCEIT with the NIH taking over the study costs or it could be investing in Vascepa is bad for your health...either way we'll know by 12-9...the regulatory period in which the label has to be updated.
The 10-25 communication wasn't meant to be clear to all, just those who know what 9-19 sNDA contains.
Trust me when I say the SEC is watching all trades between now and update. What's the ASK at? $7?
Amarin has Not accepted a deal. The FDA has accepted the sNDA from 9-19-2013...this is prior to the Ad Com. We have no idea what this sNDA is. Amarin agreed to the 11-12 label change, 8.3...and that's it.
Vascepa's label HAS to be updated by December 9th, with the Acceptance of the 9-19 sNDA...those changes where enclosed in the 11-25 letter.
11-25-2013 FDA letter:
Amarin Pharma, Inc.
Attention: Peggy Berry
VP, Regulatory Affairs and Clinical Quality 1430 Route 206, Suite 200
Bedminster, NJ 07921
Dear Ms. Berry:
Please refer to your Supplemental New Drug Application (sNDA) dated and received September 19, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vascepa (icosapent ethyl) Capsules.
----------------------
[This 9-19 supplemental approval" is the main topic of reference, the other dates and sNDA 9 label change (8.3) is just history. The new label 11-25....contains ONLY the changes Amarin accepted in the 11-4 communication from the FDA, and nothing in the 9-19 sNDA.]
-----------------------
We acknowledge receipt of your email dated November 12, 2013, stating your agreement to the labeling revisions that we communicated to you by email on November 4, 2013.
-----------------------
[We don't no what else the FDA requested, but Amarin ONLY agreed to change 8.3 and communicated it on 11-12 and posted those changes 11-25]
-----------------------
This “Prior Approval” supplemental new drug application provides for the following revisions to the package insert, in response to our letter dated July 15, 2013:
-----------------------
[FDA's pretending Oct 16th never happened, Instead skipped to communications prior to Ad Com.]
------------------------
“8.3 Nursing Mothers
Studies withomega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion is unknown; caution should be exercised when Vascepa is administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.”
------------------------
[The above is the only change Amarin agreed to from the 11-4 communication. Changes from the 11-25 letter are still to be made and to refer to the 9-19-2013 sNDA.]
-------------------------
APPROVAL & LABELING
We have completed our review of this supplemental application. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
--------------------------
[Certainly the FDA is not clear what they've approved, but at the beginning of the letter, "Please refer to your Supplemental New Drug Application (sNDA) dated and received September 19, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vascepa (icosapent ethyl) Capsules", this supplemental approval refers to the sNDA from 9-19-2013]
---------------------------
Content of Labeling:
-structured product labeling (SLP) & (CBE)
-Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE supplements for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental application, as well as annual reportable changes and annotate each change. To facilitate review of your submission, provide a highlighted or marked- up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should provide appropriate annotations, including supplement number(s) and annual report date(s).
----------------------------
[more changes within 14 days of this letter dated 11-25]
-----------------------------
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with annotated references, and (3) the package insert(s) to:
Food and Drug Administration
Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road
Beltsville, MD 20705-1266
You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions are provided on page 2 of the form. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for
-------------------------
[content labeling and promotional labeling doesn't make sense for just 8.3 change]
--------------------------
I know this is HARD to follow and IMPOSSIBLE to believe, but the FDA just approved sNDA 5,6,7, or 8 whichever is the correct 9-19-2013 number. Only Amarin and the FDA know what the heck that is? Regardless, we should find out within the 14 day window. Check the label site daily. Nothing will ever justify the FDA's reckless mismanagement, and most investors will never recover their financial losses...
Vascepa's label is being updated By December 9th.
11-25-2013 FDA letter:
Amarin Pharma, Inc.
Attention: Peggy Berry
VP, Regulatory Affairs and Clinical Quality 1430 Route 206, Suite 200
Bedminster, NJ 07921
Dear Ms. Berry:
Please refer to your Supplemental New Drug Application (sNDA) dated and received September 19, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vascepa (icosapent ethyl) Capsules.
----------------------
[9-19 What is this communication? This is the supplement approved, Is it Amarin's proposed Anchor Label before Ad Com?]
-----------------------
We acknowledge receipt of your email dated November 12, 2013, stating your agreement to the labeling revisions that we communicated to you by email on November 4, 2013.
-----------------------
[I believe this was the request to change 8.3, as this was agreed on and done before this letter was dated]
-----------------------
This “Prior Approval” supplemental new drug application provides for the following revisions to the package insert, in response to our letter dated July 15, 2013:
-----------------------
[FDA's pretending Oct 16th never happened?]
------------------------
“8.3 Nursing Mothers
Studies withomega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion is unknown; caution should be exercised when Vascepa is administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.”
------------------------
[The above is not the only change, the changes still to be made to the label refer to the 9-19-2013 sNDA, I don't know but this may be the agreed label negotiated before the Oct 16 Ad Com. It could also be why the FDA was so aggressive at the Ad Com]
-------------------------
APPROVAL & LABELING
We have completed our review of this supplemental application. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
--------------------------
[8.3 label was already done before this letter but after the 11-12, this supplemental approval refers to the sNDA from 9-19-2013]
---------------------------
Content of Labeling:
-structured product labeling (SLP) & (CBE)
-Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE supplements for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental application, as well as annual reportable changes and annotate each change. To facilitate review of your submission, provide a highlighted or marked- up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should provide appropriate annotations, including supplement number(s) and annual report date(s).
----------------------------
[more changes within 14 days of this letter dated 11-25]
-----------------------------
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with annotated references, and (3) the package insert(s) to:
Food and Drug Administration
Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road
Beltsville, MD 20705-1266
You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions are provided on page 2 of the form. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for
-------------------------
[content labeling and promotional labeling! doesn't make sense for just 8.3 change]
--------------------------
I know this is hard to follow and harder to believe, but I think we get whatever we asked for on 9-19-2013....and only Amarin and the FDA know what the heck that is?
sNDA 5,6,7,or 8 comes after 9 and includes new labeling, let's hope if full label negotiated 9-19-2013 before this horrible Ad Com disaster.
References:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
Peace out----my last post!
The letter is the same format as the 7-26-2012 NDA Vascepa approval letter.
Here's the 11-25-2013 Supplemental Approval Letter:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf
I know it fucking crazy, can someone look at the "supplement approval" letter signed by Eric Coleman and directs questions to Kati Johnson.
The new change, that was enclosed in the letter, is not the changes we saw in yesterday's label. The " new label" is suppose to be updated 14 days from the date of the letter. ... So by December 10 the we should see "new label".
Since it was "agreed" on with Amarin it would seem to be full Anchor? Anyone have thoughts on this?
Somebody want to confirm the "supplement approval" letter post today but dated 11-25-2013.
Signed by Eric Coleman.
Appears we'll see our new label within 14 days.
Williams
Amarin got something done at the FDA, just don't know what yet....
11-25-2013 label change posted today
Anybody know what going on?
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
A matter of national security?
http://clinicaltrials.gov/ct2/show/NCT01940679?term=Omega+3&rank=263
Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have anti-inflammatory properties and other documented beneficial health effects that could warrant n-3 fortification of combat rations. However, military combat rations must meet rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F), which is problematic for natural food sources of n-3s (e.g., oil and fish), which degrade when exposed to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating freeze dried n-3s with gelatin, can prevent this degradation, and Natick Soldier Research, Development and Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated n-3 technology to produce n-3 enriched ration items that withstand environmental stressors and meet shelf-life specifications for military rations. However, the bioavailability of the encapsulated n-3s in these rations is unknown, particularly when they are incorporated into high-protein food items and exposed to high temperatures and prolonged storage. In this randomized, cross-over study, civilian and/or military personnel will be asked to consume: 1) a high protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 2) a low-protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 3) a high protein food item with encapsulated n-3s (600 mg) that was not subjected to high-temperature and prolonged storage; and, 4) a low-protein food item with encapsulated n-3s (600 mg) that was not subjected to high temperature and prolonged storage. Serial blood sampling to measure acute changes in the circulating fatty acid profile will occur in the hour before and 6 hours after consumption of each ration component. The only known risks, which this study presents to participants, are those associated with venous catheter placement. The results will help military ration developers determine the ration components best suited for n-3 fortification.
JL
Relax...is not really in my vocabulary. Do you think the FDA knew anything about this study? Eric Coleman and Mary Parks have dug a hole they can't climb out of...
The Government seems to be spending money on this new science:
Metabolic Actions of Omega-3 Fatty Acids on Inflammation and Adipocyte Lipolysis in the Metabolic Syndrome
Epidemiological studies identify metabolic syndrome (MetS) as a biomarker of cardiovascular disease (CVD) risk, and recent AHA scientific statements recommend intensive lifestyle diet and exercise measures to reduce risk. Marine-derived omega-3 polyunsaturated fatty acids such as, eicosapentanoic acid (EPA) improve many constituents of the metabolic syndrome such as lowering fasting TG and glucose levels, inflammation, insulin resistance and blood pressure. These improvements may be mediated by increased fat cell storage and metabolism and lipids, reducing inflammation and ectopic fat deposition in visceral abdominal tissue, muscle and liver that results in excessive pro-inflammatory intra-abdominal fat (IAF), insulin resistance and reduced levels of HDL cholesterol, hallmark characteristics of the MetS. The anti-inflammatory actions of EPA lower acute phase reactants (APRs) and proinflammatory mediators are mechanisms for their lipid lowering and insulin sensitizing effects to reduce CVD risk. The systematic investigation of marine-derived omega-3 PUFAs on these inflammatory, metabolic and physiological parameters will provide new mechanistic insights for the therapeutic use of a potentially beneficial, safe nutraceutical, EPA in patients with MetS. Thus, it is our hypothesis that supplementation of marine-derived omega-3 PUFAs, will reduce constituents of MetS as well as systemic and tissue inflammation, insulin resistance (HOMA-IR), adipocyte lipolysis and cytokine release from AT to enhance TG storage capacity of subcutaneous AT. The reduction in inflammation and increase in insulin sensitivity will remodel adipose tissue to function more efficiently in TG uptake and storage; thus, reducing circulating FFAs and cytokines. We postulate that these metabolic effects may decrease ectopic fat deposition in viscera (IAF and muscle), an intriguing, novel outcome that provides rationale for the 9 month treatment.
The Specific Aims are to conduct a pilot 9 month randomized trial in adults with high Tg and at least one other component of the MetS to compare the effects of EPA vs. placebo on:
Aim 1: Metabolic (e.g., lipoproteins, inflammatory cytokines, acute phase reactants, glucose tolerance/insulin resistance) and adipose tissue responses (basal and insulin suppression of lipolysis (ED50), LPL activity, cytokine release and lipogenesis).
Aim 2: Regional fat distribution quantified anthropometrically as waist and hip circumference, visceral and subcutaneous adipose volumes and muscle lipid accumulation by CT-scan and body composition (total and regional fat mass) by dual energy absorptiometry (DXA).
These outcomes have potentially intriguing therapeutic implications for marine derived omega-3 PUFA supplementation as part of a lifestyle program for patients at increased cardiometabolic risk.
This is pure EPA.
Metabolic Actions of Omega-3 Fatty Acids on Inflammation and Adipocyte Lipolysis in the Metabolic Syndrome
Epidemiological studies identify metabolic syndrome (MetS) as a biomarker of cardiovascular disease (CVD) risk, and recent AHA scientific statements recommend intensive lifestyle diet and exercise measures to reduce risk. Marine-derived omega-3 polyunsaturated fatty acids such as, eicosapentanoic acid (EPA) improve many constituents of the metabolic syndrome such as lowering fasting TG and glucose levels, inflammation, insulin resistance and blood pressure. These improvements may be mediated by increased fat cell storage and metabolism and lipids, reducing inflammation and ectopic fat deposition in visceral abdominal tissue, muscle and liver that results in excessive pro-inflammatory intra-abdominal fat (IAF), insulin resistance and reduced levels of HDL cholesterol, hallmark characteristics of the MetS. The anti-inflammatory actions of EPA lower acute phase reactants (APRs) and proinflammatory mediators are mechanisms for their lipid lowering and insulin sensitizing effects to reduce CVD risk. The systematic investigation of marine-derived omega-3 PUFAs on these inflammatory, metabolic and physiological parameters will provide new mechanistic insights for the therapeutic use of a potentially beneficial, safe nutraceutical, EPA in patients with MetS. Thus, it is our hypothesis that supplementation of marine-derived omega-3 PUFAs, will reduce constituents of MetS as well as systemic and tissue inflammation, insulin resistance (HOMA-IR), adipocyte lipolysis and cytokine release from AT to enhance TG storage capacity of subcutaneous AT. The reduction in inflammation and increase in insulin sensitivity will remodel adipose tissue to function more efficiently in TG uptake and storage; thus, reducing circulating FFAs and cytokines. We postulate that these metabolic effects may decrease ectopic fat deposition in viscera (IAF and muscle), an intriguing, novel outcome that provides rationale for the 9 month treatment.
The Specific Aims are to conduct a pilot 9 month randomized trial in adults with high Tg and at least one other component of the MetS to compare the effects of EPA vs. placebo on:
Aim 1: Metabolic (e.g., lipoproteins, inflammatory cytokines, acute phase reactants, glucose tolerance/insulin resistance) and adipose tissue responses (basal and insulin suppression of lipolysis (ED50), LPL activity, cytokine release and lipogenesis).
Aim 2: Regional fat distribution quantified anthropometrically as waist and hip circumference, visceral and subcutaneous adipose volumes and muscle lipid accumulation by CT-scan and body composition (total and regional fat mass) by dual energy absorptiometry (DXA).
These outcomes have potentially intriguing therapeutic implications for marine derived omega-3 PUFA supplementation as part of a lifestyle program for patients at increased cardiometabolic risk.
They read the posts..hey Joe call me tomorrow...
Is this a shell study to take over REDUCEIT...after Amarin can't afford it?
Get it?
That's my point, WTF....it should be an Amarin study...right?
The collaborators are NIH, and the VA?!
Timing: Ad Com planning, and a ATP 4 handed off to AHA/ACC
This study is not fully designed yet...not recruiting. Look at the collaborators and PI talk for Amarin at Ad Com.
Kind of strange to have the two happening together. Amarin needs to explain and point this out.
Collaborators support the theory and the theory is the basis for Anchor & REDUCEIT!
This timing is also the exact time ATP 4 guidelines handed off to AHA/ACC to put their Statin stamp of approval.
I'm telling all of you, this is fishy timing and circumstances. Pun intended.
Certainly this doesn't back the FDA's new science BS!
The US government has already started a REDUCEIT trial after they destroy Amarin.
The metabolic syndrome raises the risk of heart disease and is currently at epidemic proportions in the U.S. It consists of 3 of the following components: central obesity, high triglycerides, low HDL, abnormal blood pressure and impaired fasting glucose levels. Previous studies have suggested that omega-3 fish oil may influence some of these components but the mechanisms involved are not well understood. Therefore, this proposal will investigate how omega-3 fish oils affect inflammation, lipids and fat breakdown by comparing it to placebo. Favorable outcomes from this study could translate into a new approach to improve heart disease risk in men and women with the metabolic syndrome.
http://clinicaltrials.gov/ct2/show/study/NCT01896414?term=Omega+3&rank=251
The governments interest in Vascepa:
http://clinicaltrials.gov/ct2/show/NCT01896414?term=Omega+3&rank=251
Something is starting to stink BAD!
Failure to disclose conflicts of interest, does it violate OIG mission statement?
Could it be viewed as obstruction? Can the FDA charge Ad Com members with Obstruction?
Hummm?
Mission
OCI protects the public health and furthers the FDA mission by investigating suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and other related laws.
OCI has the primary responsibility for criminal investigations conducted by the FDA and for all law enforcement and intelligence issues pertaining to threats against FDA-regulated products. OCI concentrates its resources on investigations of significant criminal violations that pose a danger to the public health.
Our priorities include:
1. Breaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products.
2. Criminal violations in situations where the normal regulatory process has been unable to remedy the problem.
3. Criminal violations where the risk of harm to the public health is particularly significant and the only remedy appears to be through the criminal process.
4. Criminal conduct that prevents the FDA from being able to properly regulate. This includes false statements to the FDA during the regulatory process and obstruction of justice
Japan's national plans focus:
Metabolic Syndrome
http://www.mhlw.go.jp/english/policy/health-medical/health-insurance/dl/health_insurance_bureau.pdf
The FDA hates him, he pisses them off. He needs to fall on the perverbible knife. Amarin needs to beg the FDA to expand Marine to 200-500 and exclusivity after REDUCEIT.
He needs to go.
JZ needs to be fired over the weekend:
Amarin may have made a fatal mistake, type A meeting was denied because they didn't follow procedure when requesting the meeting. They first need to contact CDER before requesting meeting. They fucked up. Type A meeting will now be after PDUFA...if at all. This must fall on leaderships head. Requesting that the board remove JZ immediately, and beg the FDA's forgiveness for having to deal with this buffoon.
Beg for type A Meeting before PDUFA and negotiate a expanded Marine label to include Trig treatments of 199-500, sign off on Anchor SPA rescindment, getting further blessing for Reduce-IT. Request no exclusivity decision be made until after REDUCE-IT.
JZ must go or Amarin as a company is done.
I hope to have the backing of an immediate 20 Million shares.
Biobillion
Nothing personal JZ, you just can't get us to the finish line.
Can you email me so I can send my draft letter to you to look at?
I lost your email in the flurry of activity.
Thanks
Williams
Sounds like a Sherman Act violation.
No, if I sue anyone it will be these ambulance chasers or the FDA. Probable both...
At this point a type A meeting isn't needed. We can petition the HHS secretary to lawfully make an Anchor and exclusivity decision based on the inactions of the FDA with the patent extension request. This is just further evidence of FDA malfeasance.
This maybe why the FDA slammed Amarin so hard at the Ad Com, defaming Vascepa and the Anchor SPA study.
June 12 letter to Beverly Friedman, FDA from the USPTO Mary Till, Senior USPTO legal advisor.
http://www.regulations.gov/contentStreamer?objectId=0900006481348650&disposition=attachment&contentType=pdf
After this letter was delivered the FDA went ape shit with rage...
35 USC 156 (a): http://www.law.cornell.edu/uscode/text/35/156
Within 60 days of the submittal of an application for extension of the term of a patent under paragraph (1), the Director shall notify—
(i) the Secretary of Agriculture if the patent claims a drug product or a method of using or manufacturing a drug product and the drug product is subject to the Virus-Serum-Toxin Act, and
(ii) the Secretary of Health and Human Services if the patent claims any other drug product, a medical device, or a food additive or color additive or a method of using or manufacturing such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug, and Cosmetic Act,
of the extension application and shall submit to the Secretary who is so notified a copy of the application. Not later than 30 days after the receipt of an application from the Director, the Secretary receiving the application shall review the dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Director of the determination, and shall publish in the Federal Register a notice of such determination.
(B)
(i) If a petition is submitted to the Secretary making the determination under subparagraph (A), not later than 180 days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period, the Secretary making the determination shall, in accordance with regulations promulgated by such Secretary, determine if the applicant acted with due diligence during the applicable regulatory review period. The Secretary making the determination shall make such determination not later than 90 days after the receipt of such a petition. For a drug product, device, or additive subject to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, the Secretary may not delegate the authority to make the determination prescribed by this clause to an office below the Office of the Director [1] of Food and Drugs. For a product subject to the Virus-Serum-Toxin Act, the Secretary of Agriculture may not delegate the authority to make the determination prescribed by this clause to an office below the Office of the Assistant Secretary for Marketing and Inspection Services.
(ii) The Secretary making a determination under clause (i) shall notify the Director of the determination and shall publish in the Federal Register a notice of such determination together with the factual and legal basis for such determination. Any interested person may request, within the 60-day period beginning on the publication of a determination, the Secretary making the determination to hold an informal hearing on the determination. If such a request is made within such period, such Secretary shall hold such hearing not later than 30 days after the date of the request, or at the request of the person making the request, not later than 60 days after such date. The Secretary who is holding the hearing shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportunity to participate in the hearing. Within 30 days after the completion of the hearing, such Secretary shall affirm or revise the determination which was the subject of the hearing and shall notify the Director of any revision of the determination and shall publish any such revision in the Federal Register.
The FDA can say F u c k You and refuse a meeting. According to guidance Amarin needs to contact CDER to request the meeting with list of people to attend and basically a script of the whole meeting.
My script:
1) Who the s h I t bag that allowed the NCE to be delayed for over a f u c king year?
2) Who's getting a bag of cash from GSK and AZN this Holiday Season?
3) How can a bunch of Fu ck sticks like yourselves make a decision to rescind Anchor SPA in 9 days but it takes you over 1 1/2 to assign exclusivity?
4) What your favorite color?
5) Do you look good in Orange?
6) Any experience making license plates?
Last piece of advice, don't drop the soap Eric.
Yes all the issues should be exposed at this meeting. I wouldn't start off by calling them criminals...but depending how the meeting finished it may get to that.
Repeated violations of FDA regulations/21 USC Reg, guidances and MAPPs all of which contributed to the demise of Amarin's Market Cap.
In contrast, fibrates have been shooting patent use codes out of their asses with two more added yesterday.
U-1447 & U-1448 for Antara
Criminal Antitrust laws have been and are continue to be violated.
Amarin's not going to this meeting to argue Triglycerides, they're going to argue facts:
1) Marine Exclusivity withheld
2) Vascepa Exclusivity Delayed, Month over Month & USPTO denied the information needed from the FDA to extend the Patent on Vascepa. This is the first violation of Federal Regulatory guidelines.
3) John Fuson, was hired by GSK to defend Antitrust lawsuit 2005, Hired by the FDA to work with enforcement and DOJ 2007-2011, hired by C&M 2011 to help the firm "legally" extend the life of pharmaceutical products OWKA How to legally form an Antitrust against your competitors.
4) FDA accepts "shame Citizen Petition" from the above former FDA attorney. By no stretch of the imagination does this petition pass the smell test. Second violation of Federal Regulatory Guidelines.
5) CP delays exclusivity Month over Month for (Non public safety reasons, the only justified Regulatory reason for delay of a 505b2 application. The Marine application is NOT complete without the Hatch-Waxmann exclusivity determination. Third violation of Federal Regulations.
6) Accepts Anchor sNDA and provides "clean 74 day letter" clear intent to mislead Amarin into the Rigged Ad Com.
7) Ad Com rigged to achieve negative vote, with the intent to use to rescind Anchor. Ad a Com broke multiple guidances related to Ad Com procedure, used incomplete documents, and potentially conspired with public Ad Com members to DEFAME Anchor, REDUCEIT, Vadcepa, and Amarin.
8) 9 days later Rescind SPA, how many meetings took place in that 9 days....zero?
9) Amarin shareholder are decimated many will never recover financial loss due to the recklessness of 1-8
Amarin's going to the a Type A meeting to hold all accountable for their actions. This was a planned, coordinated, and illegal attempt to destroy a publicly traded company using and abusing the powers given to them through positions at the FDA.
It time to pay for the crimes committed.
Vascepa was too big for the FDA and BP to submissively let through. Now the FDA and co-conspirators will pay the price for Criminally attempting to destroy a public company by violating the Sherman Act.
Triple damages!
Jail!
Oddly enough, the FDA doesn't respond to my emails like they use to. I think they get it.
Ajax, if this is traced back to the WhiteHouse we are looking at the biggest scandal ever! It'll make WaterGate look like a College Keg party.
The Statin Cartel conspiracy:
Statins reduction in overall outcomes assumes that the JUPITER trial was "accurate":
JUPITER was a randomized double-blind placebo-controlled study investigating the use of rosuvastatin in the primary prevention of cardiovascular disease. The trial focused on patients with normal low-density lipoprotein (LDL) cholesterol levels but increased levels of high-sensitivity C-reactive protein (hs-CRP). JUPITER was the first clinical trial to indicate that statin therapy may provide benefit to patients with low-to-normal LDL levels and no known cardiovascular disease.[1] The trial, which began in 2003, is directed by Paul Ridker of Brigham and Women’s Hospital.[2]-
http://en.wikipedia.org/wiki/JUPITER_trial
JUPITER studied "low-to-normal LDL" with increased inflammation markers, Inflammation is/was/and will always be the key! LDL-c is a 1/3 of the Big Picture when it comes to what we know today about the reductions of CV disease. Yet the FDA, and Statin industry has built a Monopoly-Cartel-Antitrust violating industry on partial incomplete data! Now the FDA is using "new science", guidelines only backing Statins!
The reason why the FDA delayed exclusivity? They thought they could use the cover of these stupid ass new guidelines ( Not backed By the two Professional Lipid Orgs. AACE & NLA) to rescind the Anchor SPA. Now the FDA has NO cover, no where to hide. They are exposed for what they truly are, an ORGANIZED CRIME CARTEL!!! Colluding with BP to crush Amarin. Why? Eicosanoids! They happen to be the physiological backbone to INFLAMMATION!!!!
Inflammation is the reason for Statin success, not the poor ass LDL/Trig surrogate markers.
Vascepa was too big for the FDA and BP to submissively let through. Now they will pay the price for Criminally attempting to destroy a public company by violating the Sherman Act.
Williams
We demand fair treatment and fair trade! End the FDA Cartel!
Ajax,
If the FDA keeps this up everyone will forget about Secret Service sex scandal, Benghazi, Turbo tax Tim, Solaria.....all they'll remember is FDA officials being hauled off to Federal Prison for violating the one of the most sacred of American values... Free Trade.
This literally may meet the Cartel definition. Now that will make a headline!
Williams
Big Pharma & FDA drug cartel: The FDA and big pharm have formed a drug cartel on the backs of statin medications. As wacko as this sounds, with the help of national lipid organizations that bowed out of blessing the new guidelines we may be able to prove such a collusion exists. Not only triple damages to Amarin can be paid under Criminal Antitrust laws but triple Whistleblower damages from price fixing for the Billions of dollars statins have charged Medicare/Medicaid.
What Whistleblower firm would like to represent my group?
Yes, the FDA is a corrupt now criminal organization. They clearly can make a decision to rescind a the SPA but exclusivity is just too difficult to call. Or...part of the corruption and Criminal Antitrust violations against the FDA, centers around exclusivity.
It's finally starting to be clear to all involved and not just a wacko theory of mine.
It's worth looking into.
LOCAL BUSINESS NEWS
Web petition calls on FDA to reconsider Amarin drug
By Lee Howard
November 19, 2013
COMMENTS (0)
Website makes case for Vascepa approval
An online petition urging the U.S. Food and Drug Administration to consider approving Amarin Corp. plc's application for expanded use of its new heart medication Vascepa has garnered more than 1,000 electronic signatures.
Responding to an FDA panel's recommendation last month against allowing the marketing of Vascepa in conjunction with cholesterol-lowering statins such as Lipitor, an organization calling itself The EPA Drug Initiative issued a press release Monday stating its intention to take on the committee's "flawed scientific reasoning."
The group's site includes pro-Amarin articles and a link to the petition, whose author is listed as Madi Matusow.
Calling itself an ad hoc group of physicians, patients and concerned citizens, the pro-Amarin group offered a laundry list of reasons to support Vascepa's expanded labeling, including its view that Americans will be denied an effective and possibly life-saving heart drug at a time of escalating need.
"The decision is hugely unfair to Amarin," the release said.
Amarin, an Irish company with U.S. headquarters in Bedminster, N.J., has its research-and-development hub in Groton. The company announced last month that it would be laying off more than 100 people - half its worldwide staff - in anticipation that the FDA would not approve widening the market for Vascepa when it meets next month.
The fish-oil pill, which competes with GlaxoSmithKline's drug Lovaza, already has been approved for patients with very high levels of blood fat.
To see the petition and related articles, visit www.epadruginitiative.com. The group's email is contactus@epadruginitiative.com.
A request sent by email to the group seeking more information about the campaign elicited no response Monday.
l.howard@theday.com
Share on facebook Share on twitter Share on email Share on gmail More Sharing Services
1
CLICK TO VIEW OR POST COMMENTS
In 2005 John Fuson represented GSK in an Antitrust suit. GSK planted his ass into the FDA after, to stand guard. It's not known how far GSK has infiltrated and infected the FDA. It's time to pay for your crimes, you house of cards is ready to fall.