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They have made an offer in the past. A ripp off offer that Amarin smartly refused.
Amarin only needs one or 2 decent attorneys to defend the patents if the venue is one of judicial integrity. They already have a good attorney with a proven track record.
Lets pray the patents are honored by the US courts. The difference with AMARIN is they have an approved drug and a legal leg to stand on. If big pharma wants a piece of amrn they will have to buy off some judges. Lets hope that will not happen. It looks like they are trying every means. Omega 6 as a placebo? Why ? Maybe to try to make epa/dha pill look better or as good as Vascepa?
Nice to have Amanin management that will not sell out the shareholders cheap.
I say hold the line we have come this far lets see how the FDA/big pharma does in court. A public forum they have little control over.
Which is why Amarin should be and is suing the FDA. It is the only venue that exposes all these nuances. The last part of government that still has some semblance of truthfulness.
Yes it would be cheaper as far as obtaining AMRN. But think of the lawsuits for selling people a drug most did not need--statins. The untold damage statins have done could keep the lawyers busy or a long time. That may be why they are trying to keep the truth from coming out about EPA.
Ya think the the fda is being a little hesitant to spew out more fuel for law suits? Hence the slower response?
FDA chief defends Zohydro as criticism intensifies0
By MATTHEW PERRONE
WASHINGTON (AP) - Debate over a powerful new painkiller ratcheted up Thursday as the head of the Food and Drug Administration defended the drug’s approval and a West Virginia Senator responded with a bill to force it off the market.
FDA Commissioner Dr. Margaret Hamburg told Senate lawmakers that the recently-launched Zohydro fills an “important and unique niche” for treating chronic pain. Her agency has been under fire for clearing the drug since December, amid concerns from lawmakers, addiction specialists and others that the drug will exacerbate the national epidemic of prescription drug abuse.
Zohydro is the first single-ingredient hydrocodone drug ever cleared for U.S. patients. Each extended-release pill contains up to five times more of the narcotic than previously available combination pills, such as Vicodin. Pharmacies began dispensing the drug earlier this week.
Hours after Hamburg’s appearance on Capitol Hill, Senator Joe Manchin, D-W. Va., introduced a bill that would force the FDA to withdraw the drug and prohibit the approval of any similar medications that don’t have tamper-resistant design features.
“I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug,” Manchin said in a statement. “Because of this painkiller’s high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country.”
Representative Stephen Lynch, D-Mass., introduced similar legislation in the House of Representatives.
In a statement late Thursday, Hamburg said the FDA has not had a chance to review the legislation.
“However, I look forward to continuing to work with Congress on preserving access to medications for patients suffering from pain, while addressing a serious public health problem - the inappropriate use of opioids.”
Hydrocodone is the most frequently abused prescription drug in the U.S., according to the Drug Enforcement Agency. The Centers for Disease Control and Prevention reported that hydrocodone and other prescription opiates accounted for more than 16,650 deaths in 2010, a fourfold increase from 1999.
The opiate class includes drugs that mimic the effect of the opium poppy, such as morphine, oxycodone and heroin. Doctors prescribe opiates to treat pain from injuries, surgery, cancer, arthritis and a variety of other ailments. The drugs can unleash intense feelings of euphoria and well-being, especially when quickly absorbed via injection or inhalation.
Before Zohydro’s approval, hydrocodone was available only in combinations with other non-addictive pain relievers, such as acetaminophen.
Hamburg pointed out Thursday that acetaminophen has its own well-known safety risks, including potentially deadly liver damage when taken at high levels. Zohydro provides doctors and patients with a “single hydrocodone product without that associated liver toxicity risk,” Hamburg said.
Chief among the criticisms leveled at the FDA is that regulators should have required Zohydro to be formulated in a way that would make it difficult for abusers to chew, crush or dissolve. Any of those approaches can quickly release a massive, heroin-like dose of the drug which can be fatal.
Hamburg cautioned that tamper-resistant formulations are still in the early stages of development. To date, the FDA has only approved one medication with such features, a tamper-resistant version of OxyContin in 2010.
“It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor,” Hamburg said.
Read more: http://www.washingtontimes.com/news/2014/mar/13/fda-chief-defends-zohydro-as-criticism-intensifies/#ixzz2vtrFwIjY
Follow us: @washtimes on Twitter
Hamburg gets grilled today LOOKS LIKE THEY ARE TURNING UP THE HEAT ON THE FDA DANCING CHICKENS. ABOUT TIME GOOGLE IT
Wasn't Chtp an appeal case? Now approved
Mootley goofy fool same old blah blah half of the info etc. Where do they get these clowns. They sound more like political talking heads commercials etc.
Cool article spot on too IMO
WOW!!!!! thats all I got to say about that!!! I knew this junk was toxic but didn't know it was that toxic.
Right except the vascepa cats out of the bag. We are slowly eroding Lovaza sales. Next up statin sales. The strategy of marketing to the top CV Dr.s will then teach the rest the value of this treatment. Corperate may have put up a dam but the dam will break.The cracks are already showing.
IMO the review division is just covering for each other. They may be thinking that way it legitimizes their position, 2 wrongs make it right. Or at least they feel protected by a united stand. After all they are alone in their "change science" ideology.
YES accumulation! was actually positive for the day. someone is loading cheap shares. Its been steady despite the sell off today.
Awesome article thanks
FDA CLEANING HOUSE FIRST?MAYBE they have determined the same clowns who created this mess are being investigated and so will not be allowed to rule on it again. Once it is fully sorted out they rule on it.
Thats my guess too they said the 15th in the US. So they may very well not release anything until after hours tomorrow
For those wondering what will happen pps if spa reinstated just look at CHTP instant tripple
If you think for a minute that this is not getting noticed just look the lawyers lining up to get a piece of the action! Do you think the FDA want's them lining up around the block at their door?
How could they know? The comment at the adcom was to the effect that this would be president setting and legal troubles etc. Being something altogether new no way they could predict this level of outrage. IMO the FDA review division just thought business as usual we will slip this one past, a little noise from a little bio company in IRELAND etc. and that's that. To dumb to see through the fog etc. What they didn't think about is the caliber of highly educated investors, DR's lawyers etc. who were not "hood winked" by the slight of hand game being perpetrated.
NO matter what the FDA knows they are in the public spot light with regards to Vascepa. The epadrug initiative drug website and other efforts have seen to that. So legal or procedural issues will not keep the FDA from big trouble nor will the government. Any adverse decision had better be a good one a real one. Not the trash they are getting grilled for now. They have been made well aware they will be picked apart and the outcry will not stop but will only grow if they spew out more crap reasoning.
OUR MYSTERY OPTIONS BUYER? FDA hacked, pharmaceutical companies push for online security audit
Read more: http://medcitynews.com/2013/12/fda-hacked-pharmaceutical-companies-push-online-security-audit/#ixzz2oKoFCsaR
The dilemma with the EBM reasoning in this instance is the subgroups. Those in the FDA cited trials that correspond to the 2 to 500 tri. Group did show CV benefit. BY a true and accurate evidence based evaluation the FDA conclusion is not based on EBM. Rather it points to either a grossly under qualified bungling idiot FDA or an outright corrupt FDA, maybe some of both. Now whether the real evidence is ever presented and reasoned on seems to be now solely up to the citizens or AMRN and the courts. How far the FDA is going to go in violating the laws regulating their activities is anybodies guess. I agree at this point there is little hope they will come to their senses on their own.
ARE WE TO BECOME A NATION OF MORONS??????????apsincero2003 (signed in using yahoo)
Dr. Sears, I had been taking blood pressure pills for 39 years and thanks to your book on high dose omega-3, I have now stopped taking those pills. I stopped them on August 30, 2013 and followed your zone diet with a high dose omega-3 of 9 grams per day. My systolic is now less than 130 and my diastolic is on the high 60's to low 70's. I finished reading your other three books. I am totally convinced that inflammation is the cause of all chronic diseases. I read not only your books but also those written by other authors. They run on the same theme. Inflammation is the shortest road to the cemetery.
So, now, I am concerned about this new policy of requiring statins to be taken. They are even proposing that school children with high cholesterol take statins. Because statins have an effect on memory, we may become a country of morons 10 to 20 year from now. If the children in China do not take statins as our children do, China would easily overtake us.
Dr Arcadio P Sincero
Reply · · November 21 at 11:22am MORONS??
No "new Science" for Europe. Oh did you notice 7.2 million shares accumulated the last 5 trading days.
Dr OZ show what do you think? I thought he did a good job. Definitely not in the FDA "NEW SCIENCE" camp. Next up next week he is going to torpedo the " NEW AND IMPROVED STATIN GUIDELINES". IMO he listened to the people from here. He seems to be a DR. who views the patient above his bank account.
Colloidal silver is considered an antibiotic but is really just silver ionized water. Not really an antibiotic in the true sense of the word.
Dilemma with Vascepa is other Drugs trying to become an add on are failures. IMO they will continue to be failures. Even the new inhibitor. Remember INX189? New wonder drug failed phaze3 do to death. Vascepa works but since no other drug has succeed in this application it will have to prove it on it's own merits according to the idiots at the FDA who can't see the nose on their face. Only their buddies stock accounts.
Agreed but just can't help myself if these guys think they are going to win this one there nuts. In the end no matter how long it takes Vasceoa is going to severely reduce the need for statins. Its a done deal just a matter of time.
So more statins? Huh? Lets see people are able to reduce there intake of statins by adding Vascepa. Statins kill muscles. Wait a minute isn't the heart a muscle? So our medical brain trust isn't sure Vascepa will help. Humm well according to patients using it and doctors prescribing it, it does. Now if the heart muscle is stronger will it last longer? Gee you would think so. But what do I know I'm just a laymen with common sense. Not a collage educated FDA doctor who has no common sense. Well I guess they might need 7 more years of night school with professor Bumblemeyer. Maybe then they could realize the real world is going to do what works and makes them feel better and live longer. Despite there well meaning foot dragging re the anchor indication. Well meaning for their Stock account an their buddies stock account.
Just a suggestion to Amarin re sales. Since they will have to sell of label. Why not also target the doctors in the well to do areas that can afford to pay out of pocket. Those people go to a doctor to feel better. Not to make the FDA's day.
No 2nd Generation SS/GESTAPO more retarded than the 1st but they have managed to put at risk 36 to 80 million lives
Long here, This SPA/science fraud is a new president so how can you compare it to anything done in the past? The FDA has now lost what little trust they had. Unless you are big CO. and can arrange for secret kick backs you can no longer expect any favorable process by the FDA. The only way FDA will get any credit score back is to do a 180 on this. Hard to believe it will according to most authors. I just found it hard to believe the FDA would be so bold, in plan view of John Q Public, as to think people do not see what a sham they are trying to pull here. YEP looks like the Gestapo is back in business. Those who managed this circus adcom seem to IMO have no more moral conscious or regard for the population that needs this drug. IN my limited dealing with this type the only thing that controls them is the arm of the law. So I for one was happy to hear that Amarin has decided to pursue that if need be. By the way if Amarin can get criminal charges filed the whatever DA will foot ALL LEGAL COSTS to prosecute and get to the bottom of this.
FRom the INV. Vilg. board RE APPEAL
: Where is everyone
Couldn't disagree with you more - I think our chances are good, especially with medical professionals on our side - a bombshell of protest from the AHA etc. would shine a big ugly light on those FDA cockroaches. And the FDA just got caught dirty-dealing again:
Feds launch probe of AstraZeneca's controversial late-stage Brilinta study
October 31, 2013 | By John Carroll
When EP Vantage went back to look over some of the bullish peak sales projections made for a new generation of medicines, its analysts pulled out AstraZeneca's blood-thinner Brilinta as one of the industry's top duds. Once expected to crest at $2.52 billion a year, most analysts now don't see it hitting the $1 billion blockbuster mark, with a poor impact in the U.S. market dragging down projections.
Now AstraZeneca ($AZN) has another Brilinta headache to deal with. In its third-quarter earnings release the company revealed that the U.S. Justice Department's civil division is probing PLATO, its big clinical trial of Brilinta. The feds demanded "documents and information" on the study. And the pharma giant noted briefly that it will be cooperating with investigators.
While the company offers no details about exactly what the feds are after, the PLATO study has been subjected to some harsh criticism from James DiNicolantonio, Pharm.D., and Dr. Ales Tomek, of Charles University in Prague. The two raised serious questions about the study results last summer in a report published in the International Journal of Cardiology. They highlighted concerns that study results reviewed by an independent CRO demonstrated a worse outcome for the drug--ticagrelor--than the clopidogrel arm compared to the positive results reported by AstraZeneca's investigators.
They also reported that almost half of the favorable results for Brilinta were drawn from just two Eastern European countries, Hungary and Poland. Reporting on cardiovascular events appeared to favor Brilinta and "an estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to 'softer' endpoints (this was not shown in the FDA review for clopidogrel), and four FDA reviewers voted for non-approval of ticagrelor."
"The FDA report highlights what appear to be multiple serious deficiencies in the reporting of the PLATO results, which clinicians will not have gleaned from the primary publication alone," they wrote, according to a report in MedPage Today. "Individual clinicians may therefore wish to carefully reconsider their practice of ticagrelor prescription for this indication. Guideline bodies should also evaluate the information in its totality."
Oh, and now the EMA is after them too:
EU watchdogs demand info on AstraZeneca's disputed Brilinta trial November 8, 2013 | By Tracy Staton
Last week, AstraZeneca ($AZN) succinctly disclosed that Department of Justice investigators are digging into its data on the blood thinner Brilinta. Now, European regulators are adding their shovels to the effort. If they're not satisfied with their findings, AstraZeneca's hopes for pumping up Brilinta sales could be in vain.
At issue is the PLATO trial, a pivotal study that helped lay the foundation for Brilinta's regulatory approval. The head-to-head trial against megablockbuster clot-fighter Plavix helped support a superiority claim on Brilinta's FDA label when its was approved in 2011. That gave AstraZeneca some extra marketing ammo. And that was important, given the fact that the Sanofi ($SNY) and Bristol-Myers Squibb ($BMY) drug--the standard of care--was about to go off patent. The study also gave AstraZeneca some pricing support; in setting a premium price for the drug in Europe, the company cited PLATO data as justification.
But how justified was it, really? The European Medicines Agency (EMA) said yesterday that it asked AstraZeneca for more information after the Justice Department's probe came to light. "The EMA takes seriously any information that may have an impact on the profile of a drug's benefits and risks," an EMA spokeswoman told Reuters. "At the moment we are at the point of trying to understand what is going on."
PLATO has come under fire before. Researchers have pointed to flaws in the study, with some suggesting that the data appeared to be fudged to benefit Brilinta. Last summer, a report in the International Journal of Cardiology said an independent group's review of PLATO data yielded a more negative picture than AstraZeneca's analysis.
One more dynamic IMO Controversies like the one created by the FDA mess will have the exact opposite effect intended. It often has the effect of more rapidly making known Vascepa than would have been had this been just another adcom.
LIKE the quick trans fat rejection by consumers, when it became widely known. If Amarin can last long enough for the word to get out, Vascepa sales will rise rapidly. IMO you haven't seen anything yet. There is so much "fish oil bias" Most don't know what they have here.
YA I know,,I just felt compelled to give some real life perspective. Some reality to the real consequences to human lives.
40 Million LIVES ?
Lets see Hitler kills 3.6 million
Stalin 36 Million
FDA Recends Vascepa spa that cloud lengthen or save 40 million of there own people
WHAT'S wrong with this picture? If I was one of those heart patients I would be very upset right now. As it is I almost lost my life to the cancer that trans fats caused which the FDA would not remove from the market when asked to over a decade ago. How do these people sleep at night?
Not Just Statins Think about it Vascepa has shown potential to treat a bunch of inflammatory conditions and thus could reduce the need for a number of drugs. Not just Statins. Does that invite opposition from others knowing this drug could seriously hit their bottom line? Interesting, just was thinking about that today. Why is the FDA so bent on burying Amarin.
On another front some on various boards have been asking why no insider buying going on. IMO that could make them look like they helped created this mess to take advantage of it.
BD yes slowmover I see your point, at adcom the reports for the subgroups were never mentioned and the slides never when asked for. Not the ones on investor village post 1062. The point of the adcom is to get other doctors opinion of the data. How can they form their opinion if they don't get to see it for themselves? Funny in the bd's as you say there is evidence of attempting to obscure the data.
That's what IMO the bottom line is. Big pharma knows what EPA will do as they just like us get feedback from the field. They are hoping Vascepa stays out of the public eye as long as possible. That's why the dynamics of this relatively unknown drug and a small company with a limited budget is really at a disadvantage. This drug needs maximum exposure.Once the drug gets well known it will be very difficult to keep pushing it down. Amarin's tactics should include re allocating more towards advertising To not just the dr's but also the patients.