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Yes AF is entitled to his opinion.I tend to be more trusting of those with real skin in the game, like AMRN management.Its hard to believe they would misjudge or misrepresent the validity of the study.They are well aware the FDA will carefully review all the data.
Exactly people get lost in the technical aspects. They forget the bigger picture. How does the saying go"can't see the forest for the trees"
Cramer in the past viewed Amarin as a highly speculative stock. GUESS WHAT SPECULATION IS OVER it's known as Reduce it study success.
Supply and demand Its hard to apply here. So far not really enough Vacepa to go around. Should be an interesting dynamic when they set prescription price margins
JL had it right
We recognize that label expansion is important to promotion but we have reached agreement previously with the FDA that allows us to communicate information which is truthful and nonmisleading which means providing information with various appropriate qualifications to healthcare professionals and particularly after publication will be able to take steps that will allow us to communicate this information to healthcare professionals. We are doing some of that already, but with lots of qualifications including the fact that is not yet published and not yet presented.
Jl has it right
We recognize that label expansion is important to promotion but we have reached agreement previously with the FDA that allows us to communicate information which is truthful and nonmisleading which means providing information with various appropriate qualifications to healthcare professionals and particularly after publication will be able to take steps that will allow us to communicate this information to healthcare professionals. We are doing some of that already, but with lots of qualifications including the fact that is not yet published and not yet presented.
Thanks so much for the info. even with the restrictions it seems like Vacepa will become well known quickly. I just hope any lingering doubts about it rapadly disappears too
Go on YouTube and search for Dr Esselstyn
Sales reps? Seems the FDA settlement with Amarin gave them the right to speak about truthfull factual information re Vacepa with doctors. So in essence the reps can begin making the RI info known now.Which some Doctors may then begin to perscribe it for that off label use. Kind of unique situation to Amarin. Most newbes might not be aware of the increase in sales that could result verses the usual waiting for the regular approval process to fully mature. I wonder how many new investors know about the Negotiated agreement and the possible quick uptick in sales. I'm probably not the sharpest tool in the shed here. Maybe somebody's already expressed similar thoughts but I haven't noticed it. Vacepa has definitely caught many by surprise so it may be there is a learning curve that hasn't caught up to the pps?
Shaking out the stops?
Looks like the fog is lifting. The stigma is being outed. How high will it go is the question. Block buster drug. Nobody really understanding what it's worth at this point. So analysts are shooting in the dark. Maybe quite a ride. Have to wonder how clueless those who sold at 10$ were.
Yep FDA ,rigged ad com ,spa cancelled etc.I was there and Just as upset as anyone. Just how will the FDA pull such stunts again? I suppose anything's possible. Armageddon maybe? There isn't a stock with no risk. Just seems I'm having a hard time figuring out what that could be
I guess you have to consider what his remaining stock will be worth in the months ahead. Wild guess 6 to 10 times it's current value? How much does it take to have enough? Originally it was stated buyout offers would not even be considered for less than 30$ per share.That was pre RI trial.How much has USD devaluation been since? Just a very ruff guess but it would seem even with the stock dilution that has already occurred maybe 60$ minimum or more PS.starting point for offers now.I really can't fault them for wanting some compensation now,life is short etc. The science has been proven now. Hard to believe there is anything to worry about anymore.
Vacepa has historically been a "grind it out" story. The established pharma powers have been very sceptical of it. For those who believe in the science they can buy now at what still is a ridiculously low price because of this popular stigmatized view. Once that stigma is gone it will be too late.
JL a big THANKYOU! for your contributions and insight. YOU THE MAN! I will not be selling anytime soon. The stigma of "this is fish oil " no doubt will put a damper on the speed of the share price rise, but I agree what were seeing now is nothing.
Exactly
Get another doctor who is more in touch with the facts and reality.
And With a Food supply full of Inflammation causing foods there is a large supply of people in need of the reduction of Inflammation. GMO foods, Hybrid wheat, sugar sugar and more sugar. All courtesy of drs Bumblmeyer at the FDA.Makes you wonder who's or which cartel is in charge
Thanks from a stage 2/3 CRC survivor 12years. That's one thing I did was bomb myself with fish oil and still do 4pills a day
Sales Are exponentially increased by direct client contact. For the first time Amarin reps have freedom to present CV related data face to face. The longer this happens that much more the cat will get out of the bag.No way for the FDA to put it back in except for a failed RI study which everyone except them knows will not occur. As long as an injunction remains in place we win.
No matter what the currupt funds and their buddies at the FDA try Amarin now has a real shot as a very profitable business. Amarin management has survived being kicked in every possible way and has come off the winner. Quite an accomplishment in the shark tank they have had to negotiate. I just hope the thieves trying to steal Vascepa are not able to buy off the US judicial system.
Thanks for the reply JL always read your posts.
Agreed if there was a way to prove it AMARIN would have done so. Still very compelling facts make it hard to believe there isn't something going on. Especially with the huge $ at stake here. Here is a very interesting debate where corporate and the FDA seem to have little interest in public health. Oh and he does mention EFA'S at the end.Interesting how the Canadian government and US corperations are attempting to discredit this Doctor. Thier arguments against him are just as ridiculous as those in the adcom .
60 Minutes? remember whenJL and others were tossing around a magazine show etc? Well Let the FDA take this mess up a notch an lose again! Now you got a story that will sell. As a bonus now instead of trying for an expanded indication you get all news sources coverage for free.Think Vascepa flying of the shelves.Who would need big pharma to promote it then? Fun to ponder.
SEEMS the last thing an FDA with full mental capacity would want is to draw yet more attention to their curruption and incompetentcy. Which is just what yet another loss in a higher court would do.
Folks just don't delude yourselves Amarin has only gotten this far by calling in the law!I hope Amarin never never drops their guard against the lawless currupt agency they are dealing with. If there is any deal I am glad the law will oversee it. Why after all the crud we have seen from the FDA would Amarin legal team in any way trust the FDA again? What ever is "agreed upon" the court has to remain in oversight somehow. IMO this is critical to restoring investors confidence here. It would be fantastic if Amarin gets what they should. If they do it will only be at the point of a judje and his enforcement team.
Definitely is a show me market now. Especially with regards to Amarin. With the past disappointments people are jaded with regards to Amarin. Too bad for those not knowing the whole story, because it looks like the table is now set for success.
Guess we know now why Amarin is down small caps being the first to get crushed in a down market. IMO a good sign we are hanging in there where we are at. Was also thinking how I was looking for a home run stock when I got into this. Times have changed. Now we have sales and court victories that make this a more legitimate investment. How times have changed.Funny after all this time etc. how the market still seems to miss the potential here. Oh well just gives ones more time to buy more.
THE MAN WHO BEAT THE FDA what's fascinating is the same law suit process that worked is what Amarin is pursuing. Also the quote " it always ended up they wanted more studies done etc." Too he doen't think cholesterol has a lot to do with this .msn news
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How a 100-year-old scientist’s ‘lonely battle’ against trans fat led to a ban
Washington Post - Washington Post
The Washington Post
Brady Dennis 3 hrs ago
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No one was more pleased by the Food and Drug Administration's decision Tuesday to eliminate artificial trans fats from the U.S. food supply than Fred Kummerow, a 100-year-old University of Illinois professor who has warned about the dangers of the artery-clogging substance for nearly six decades.
"Science won out," Kummerow, who sued the FDA in 2013 for not acting sooner, said in an interview from his home in Illinois. "It's very important that we don't have this in our diet."
[FDA moves to ban trans fat from the U.S. food supply]
In the 1950s, as a young university researcher, Kummerow convinced a local hospital to let him examine the arteries of people who had died from heart disease. He made a jarring discovery. The tissue contained high levels of artificial trans fat, a substance that had been discovered decades earlier but had become ubiquitous in processed foods throughout the country.
Later, he conducted a study showing that rats developed atherosclerosis after being fed artificial trans fats. When he removed the substance from their diets, the atherosclerosis disappeared from their arteries.
Kummerow first published his research warning about the dangers of artery-clogging trans fats in 1957. More than a decade later, while serving on a subcommittee of the American Heart Association, he detailed the massive amounts of trans fat in the shortening and margarines lining grocery shelves, and helped convince the food industry to lower the content in certain products.
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Despite Kummerow's research and warnings over the years, artificial trans fats remained a staple of processed food for decades. Well into the 1980s, many scientists and public health advocates believed that partially hydrogenated oils were preferable to more natural saturated fats. And the food industry was reluctant to do away with artificial trans fats, which were cheaper than their natural counterparts, extended shelf life and gave foods desirable taste and texture.
[FDA: Foods that might have trans fats in them]
"The industry was very much for trans fat," said Kummerow, noting that each time a group formed to study the issue over the years, it seemed to turn out the same way. "It always ended up that you had to have more research before you could come to a conclusion."
Frustrated by the lack of action, Kummerow filed a 3,000-word citizen petition with the FDA in 2009, citing the mounting body of evidence against trans fat. The first line read: "I request to ban partially hydrogenated fat from the American diet."
By that time, he certainly wasn't alone.
In the 1990s, more and more studies had shown that trans fats were a key culprit in the rising rates of heart disease. The advocacy group Center for Science in the Public Interest also petitioned the FDA in 1994 to require that the substance be listed on nutrition labels -- a move that the agency put into place in 2006. In 2002, the Institute of Medicine found that there was “no safe level of trans fatty acids and people should eat as little of them as possible.” As the dangers of trans fat became clearer, public opinion also shifted, and food companies increasingly removed the substance from products, though it remained in a broad range of foods, from cake frostings to baked goods.
Four years after filing his petition and hearing nothing, Kummerow sued the FDA and the Department of Health and Human Services in 2013, with the help of a California law firm. The suit asked a judge to compel the agency to respond to Kummerow's petition and "to ban partially hydrogenated oils unless a complete administrative review finds new evidence for their safety."
Three months later, the FDA announced its plans to effectively eliminate trans fats by saying that the substance no longer would be assumed safe for use in human foods. Tuesday's action finalizes that initial proposal, and manufacturers will have three years to reformulate products or to petition the agency for an exception.
[Trans fats to be phased out, FDA says]
Glad as he was to see the government finally eliminate most trans fat from the food supply -- a move he thinks will save thousands of lives -- Kummerow doesn't consider his job done. He's pressing forward on research about how fried fats can affect metabolism, hoping to add more academic journal articles to his long list of publications.
As for his own diet, Kummerow said he doesn't spend much time worrying about cholesterol, which he doesn't believe is a central culprit in heart disease (he even wrote a book on the topic). He drinks whole milk and eats eggs. But he does steer clear of fried foods, margarine and anything associated with partially-hydrogenated oils.
Kummerow recalled how last fall, at his 100th birthday celebration, someone brought a ready-made cake to the party. When he studied the label, he quickly noticed that it contained trans fat.
"I threw it out," he joked. "There were a lot of other things [to eat]."
READ MORE:
Good news, chocolate lovers: The more you eat the lower your risk of heart disease
Common heartburn medications linked to greater risk of heart attack
5 things about trans fats and the FDA’s proposed phase out
DDT's breast cancer legacy: Daughters of those exposed have 4x higher risk of breast cancer
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So according to these brainiacs we should see a bunch of Asian zombies due to the elevated epa in their bodies. NOT!
HA HA HA HA CAN't HELP IT HA HA HA FDA HA HA FDA DUMMIES!!! would be funny except for all the harm it's done. Still thats my first reaction.
Thanks JL for the summery
Fish oil provides a second benefit, in that it reduces T-cell stimulation in the intestinal tract that may be involved in triggering inflammation and auto-immune responses.
From; http://www.itmonline.org/arts/lox.htm
And I second that welcome back emotion JL. Really do appreciate your professional perspective!
Here's the multitasking that got me interested in Vascepa from the perspective of a stage2/3 cancer survivor.
http://www.envita.com/cancer/chronic-inflammation
I have not a prescription I sure would like to get one. I do take a high quality fish oil 4 1000mg pills a day. I have taken more but after 12 years clean, that seems to be the max my stomach can handle.
I second that thought That's a huge chunk of money or vote of confidence
HERE IS a similar scenario that speaks as to the mountain AMARIN has to climb
Results and Science will eventually overwhelm the FDA. They will have no choice when awareness of inflammations effects are made plain and well known.
WOW SCRIPTS UP CRAMER SAYS BUY BIO'S we are on a roll, sweet
Summer street science reasoning can be found on the toilet stalls of the Fda or any statin suppliers