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JL-
USC Title 21 Ch 9 sub ch III 335a, ASN and GSK take note (If your f'ckn with Amarin a CP requesting a 10 yr ban will be made)They both qualify for a request to be made now.
Williams
Amarin's hiring through:
http://www.jobsonline.com/index.html?KEYWORD=amarin&cpd=&gclid=CPqQxrGIwroCFYhcMgodFkQA-A&md=&nwk=s&pos=1s1&tp_campaign_id=941&traffic_id=473604381
Something new on the press release:
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Something to follow:
LONDON (Reuters) - AstraZeneca is being investigated by U.S. authorities over a major clinical trial that was used to win marketing approval for its new heart drug Brilinta.
The British drugmaker said on Thursday it had received a civil investigative demand from the U.S. Department of Justice seeking documents and information regarding the so-called PLATO study.
AstraZeneca, which highlighted the investigation in its quarterly results statement, gave no further details but said it intended to cooperate with the inquiry.
Brilinta is a key new product for the company, although its progress to date has been slow, with sales in the third quarter edging up to $75 million from $65 million in the three months to end-June.
A key challenge for Brilinta is the fact that U.S. doctors tend to use high-dose aspirin for cardiovascular patients and clinical trials suggest AstraZeneca's new drug does not work as well in this setting.
Consider also contacting Senator Joe Manchin.
Just got a similar message...those Philippine robbers?....
The FDA has talked out of both sides of it's mouth on this issue. It depends on who their talking to....I hope Amarin can negotiate a Fibrate like label as the FDA still seems willing to back their high Trig treatment with the recent added U-1416 code for Fibrates on 10-25. Does anyone know what the SPA wording was for potential label?
I hope the Ad Com committee knows they where used as tools of blame if REDUCEIT is successful. Really makes me want to sign up for that job....NOT!
"Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL). Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL."
http://investor.amarincorp.com/secfiling.cfm?filingID=1193125-13-416032&CIK=897448
2011 Accord Study Ad Com:
Summary
• Mixed results from fibrate monotherapy cardiovascular outcome trials
– Gemfibrozil monotherapy trials: “positive” – Fenofibrate monotherapy trials: “negative”
• Trilipix NDA approved based on favorable HDL and TG changes
• ACCORD-Lipid trial
– Fenofibrate plus statin vs. statin: “negative”
– Suggestion of harm for women • NotobservedintheFIELDTrial
– Suggestion of benefit for TG >204 mg/dL and HDL-C < 34 mg/dL • Somepost-hocanalysesoffibratemonotherapyCVtrialsmay
suggest benefit in patients with TG >200 mg/dL and HDL <35 mg/dL
“TheresultsoftheACCORDLipidsubgroup analysis, together with those of previous fibrate trials, support the hypothesis that fibrate therapy may reduce cardiovascular events among patients with clinically significant dyslipidemia (i.e., hypertriglyceridemia and low HDL cholesterol levels).”
• “A definitive clinical trial involving such persons would provide critical information regarding this issue."
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm258119.pdf
By "rescinding" SPA based on high Trigs don't need to be treated, the FDA has regulated medicine. Note if you have been treated using Fibrates, Niacin, or bla bla.. and have suffered serious side effects from these medicines you are due compensation. On October 29th the FDA has ruled treatment of high Triglycerides 200-500 is not medically indicated.
Please pass along to all ambulance chasers.
This is new new science, the FDA will restudy the studies then ask for another PDUFA fee, and REDICKYOU study. We'll win for sure this time.
Our only hope is management can pull off a miracle...and I have very little confidence in that.
JZ.... Your fired turn in your keys,,, next,..
We'll we do have the smart skilled thing to fall back on....
Please send this to the FDA and have them cut me a check for $1 billion. Thanks
If REDUCEIT is a success the FDA will bring all the dead back to life. You mortals need to understand, the FDA is here to help you. They only approve time tested medication like cyanide, OxyContin, rat poison (literally), Vioxx, and Tylenol.
All hail the FDA! They know better than the untrained stupid AACE panel (that will be called to testify against the FDA).
BASF to provide a $1billion litigation fund....cool!
The FDA has enough data to pull labels on Fibrates, Bile acid crap, and Niacin for failed studies.
They also have info to pull most DM 2 drugs for increase CV risks.
If none of the above happen after they reject Anchor, my new hobby will be making the FDA look like a bunch of idiots. That's a promise.
Yup, except I don't think management will give me $900,000, so I'm Repo'n all of the Board of Directors cars. Hope they have some nice rides.
When Amarin announced sNDA my read was they asked for REDUCEIT, if I was feeling like being a real dick I'd go back and find my post. Instead I'm gonna get another drink... I'll be back....
Zum and all, Keep the pressure up.
http://www.foxnews.com/health/2013/10/29/study-questions-fda-shorter-drug-approval-times/
The FDA's latest comments on surrogate markers.
I believe the FDA has no access to data. If REDUCEIT reaches 15% statistical reduction in CV events the Steering Committee would have to break the news. Not really sure how it works?
Has the FDA asked Amarin for more data related to Vascepa or the Placebo at any point during Anchor that Amarin has not met? This is the question that must be answered by Amarin. Remember the tone of the Ad Com, the FDA has/had no intension of approving Anchor on or before 12-20. The FDA has forced Amarin to make the next move, Amarin chose to consolidate assets.
Amarin is negotiating a label change for an already approved drug. Anchor will be on the new label. This doesn't mean the FDA approved the new indication...just the label. I expect Amarin to also have reference to REDUCEIT and JELIS on new label...this was stated in the Marine Review Documents.
My worse case FDA FUBAR's Anchor SPA, but includes Anchor/REDUCEIT/JELIS on Label. Amarin cuts costs by reducing staff (not sales force). Amarin has 316 direct sales staff run by Rick Shalaby/PDI they essentially get rolled over into a PDI contract sales. This is essentially the cost of running REDUCEIT per year.
Every 6 months that rolls by and the Steering Committee for REDUCEIT recommends the study continues is an excellent sign. There must be some diversion from the treatment and placebo for this to be enrolled to >6000 and lasted for two years.
I'm in Amarin for REDUCEIT, it might be fight to my death.
I suggest we follow Zum's lead and continue to fight the man/woman.
VVUS drug had/has clear safety signals, Vascepa doesn't.
It's all good. I didn't really appreciate how hard Amarin kicked the FDA in the nuts with that June CP.
Zum's doing a great job organizing "the fight", but you have to know who your up against.
CDER retailated against Amarin after the USPTO forced CDER's exclusivity hand:
http://www.regulations.gov/contentStreamer?objectId=0900006481348650&disposition=attachment&contentType=pdf
35 U.S.C. 156 (d)(2)(A)
(d)
(2)
(A) 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.
Was this Ad Com a show for HHS secretary? Should we be directing letters here also?
Doc,
2013 AACE guidelines completely changed from 2012 to ad EPA/Omega 3. If you have time read the full statement.
https://www.aace.com/files/algorithm-07-11-2013.pdf
Otherwise great.
Williams
Yes, as I posted, requesting a joint investigation. The last joint investigation put a FDA scientist in jail.
Zip
Yes my thoughts also. The angle I'm persueing is a request for a duel investigation, both the OCI (tasked with the responsibility for criminal investigations conducted by the FDA) and SEC agents. The Ad Com was legal cover to beat the crap out of Amarin Corp using lies and deceit.
Do you know what public Ad Com member didn't disclose his work in a current Cardiovascular outcomes study?
Williams
Here's one patent:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=7&f=G&l=50&co1=AND&d=PTXT&s1=Capsule.TI.&s2=%22Fatty+acids%22&OS=TTL/Capsule+AND+%22Fatty+acids%22&RS=TTL/Capsule+AND+%22Fatty+acids%22
http://assignments.uspto.gov/assignments/q?db=pat&pat=8383678
Looks to be the only relevant patent, what they put in the cap Amarin owns the IP.
Good letter JL, short to the point. Balloon pumps are still used today to help those recover from massive MI's...that's really cool.
Will
They have a capsule patent...but not what's in it. That's Amarin's.
Amarin's Omthera patent's
13685281 10-24-2013 Track 1 Request Granted
13685291 10-22-2013 Mail Notice of Allowance
I see your point, we should sell them to AZN.
I forgot Amarin owned Epanova's IP....thanks!
Omthera's applications have both been rejected in August.
13797557
NONE
US20130209556
OMTHERA PHARMACEUTICALS,
13734846
NONE
US20130177643
OMTHERA PHARMACEUTICALS, INC.
Parks has been following Amarin through the process since Marine. She's pissed Amarin's ready to sue at the drop of anything but NCE. 6-28-2013 USPTO patent extension request. NCE is based on Icosapent Ethyl never before being in the OB. Patent life is money, if the FDA rules unfavorably this will be litigated.
http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=Vascepa;fp=true;ns=true
So Mary Parks and the FDA retaliate by abuse of power at the Ad Com, implying SPA is done. Under FTCA act nothing can be litigated though.
However, when/if the FDA breaks binding contract all parties including investors can claim damages against the FDA through FTCA act and SF 95. You must file within two years....
http://federal-tort-claims.com/images/form%2095.pdf.pdf
$2.4 Billion dollars in damage to Amarin's Market share alone 7-27-2012 to 10-25-2013.
Remember that GSK billions of dollars in fines? Hey, GSK I think Amarin can get that money back;)
"Go ahead...make my day"
The second closed door AdCom.
We have a group working on those sound bites.
The "failure" reduced events by 8-11%, if you happen to be in that 8-11% not grabbing your chest...I doubt you'd consider it a failure.
Listen! My assertation is the FDA has not changed opinion on Surrogate Markers, or intends to renege Anchor SPA. I base this on the approval of a new use code, and new printed label for Fibrates. If the FDA thought so strongly about the "failed" Fibrate studies they wouldn't contain the 8-11% reduction in CV events in the new label 10-18-2013. This label was signed and approved by Dr. Eric Coleman, for those that don't know he was at Anchor Ad Com.
The FDA scared the crap out of longs and Amarin. I hope they find it in their hearts to not let the company layoff half the sales staff before they approve Anchor.
This is a Fibrate use code for treating high Trigs. Patent use codes where updated for Fibrates shortly before Marine approval. Is this a trend?
Yes, it was a lot more exciting in my own head....
IMO it shows the FDA hasn't changed opinion or intended to break SPA.
DISCLAIMER STATEMENT
The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought this supplemental application, VASCEPA (icosapent ethyl), NDA 202057/Supplement -005 to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting
My disclaimer:
My thoughts might not be reality, but they do make me feel better.
3 week early update of OB...trying to cover AZ for NME statement.
Read the disclaimer, it was on top of the FDA's BD. It doesn't however excuse "defamation", "intent to breach contract", or supersede Tort law.
DISCLAIMER STATEMENT
The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought this supplemental application, VASCEPA (icosapent ethyl), NDA 202057/Supplement -005 to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting
The new patent use code only applies for Antara (Fibrate), they where awarded a new patent, 8481078.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Anyone remember the FDA Ad Com member exclaim to Dr. Hiatt, "this is not a NME", after Hiatt was busting on the FDA for not presenting safety data?
Well the FDA OB was just updated 3 weeks early, with no change to Vascepa exclusivity.
U - 1416 USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
The use code was approved and signed by Eric Coleman 10-18-2013. The Ad Com wasn't enough to deny treatment of high Trigs. It was enough to create panic selling and the company to layoff half it's sales force though.
Fibrates also kept label wording, with "failed" studies showing an 8% and 11% reduction in CV events.
The Ad Com was like yelling "FIRE" in a crowded movie...then after people are trampled to death..exclaim..."just joking".
Most on the board have the info....ya might want to discuss when to drop it on the public.
BioChica's has the info;)
Don't sweat it, Amarin haulted patent and sited and reference Ad Com Documents. They haulted it on 10-14 two days before the FDA gutted Amarin's shareholders.
Not imaginary, I'm going to notify Amarin first. It very material and I'm surprised it hasn't been reported.
When I give it, I'll just post it with the link. Maybe if a HF offers me "one million dollars" I will sell them the info...
Nah...$10 million maybe...$20 million for sure;)
I'm thinking about a treasure hunt starting at 7 AM EST... I'll drop crumbs until someone find it. Or should I wait until the markets open? What's fairer pre-market or opening bell?