BB, can you expand on the reasoning when you have time?

"Only reason FDA ruled against Fuson petition? They where caught red handed trying to rob Amarin stakeholders blind."

TIA.

This is the biggest BS I heard from Ajax, slightly ahead of his trashing of JT for not negotiating with the FDA over MLK weekend. NCE is the third most important value driver to our Amarin stock value. Strength of our patent estates and REDUCE-IT success being the most important.

BB, any connection with the timing of the release of CP comments right after Judge Moss finished gathering NCE case materials, i.e., Judge Moss probably thought he has all materials he needs to make NCE decision, not aware of updates of insightful and relevant CP comments.

Till right after you sell, as always.

AT, are you suppose to be sleeping?

BB, correct me if I am wrong, the damage to Amarin so far regarding NCE is only legal cost, which is in the millions.

Piper, if your charting were so accurate, you should be filthy rich by now. What's wrong?

Bad Advice, did you remember what you wrote in September of last year,

"It's not that they think R-it continuation is bad news, it's b/c the the amount of time it will take to reap the financial benefits of R-it is >1.5 years. Until then your investment is dead money. You can sell now (like 4.4 mill shares did today) and use that money for something else. You can easily get back in at $1.50 in a year or so. PPS is doing nothing until then. You can forget about Anchor......ain't gonna happen."

At least you live up to your namesake. LOL!

The long-term (3.5 yrs) assumption of 1g of polyunsaturated fatty acids (n-3 PUFA) improves significantly the prognosis of patients who have suffered a recent (<3 mos) myocardial infarction; the benefit is 10-15% relative reduction of the events included in the primary end-point (deaths and non-fatal cardiovascular events). This benefit is almost exclusively due to the decrease of total deaths (14-20%).

At variance with the results obtained with n-3 PUFA, those related to the other experimental treatment, vitamin E, 300 mg/day failed to reach formal statistical significance, though the data on mortality could be seen as highly suggestive of a possible beneficial effect to be verified with the information expected from other ongoing trials. The GISSI-Prevenzione provides also evidence that the combined administration of the two treatments does not add to the beneficial effect of n-3 PUFA.

These results have been produced by the GISSI-group (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto), who since 15 years is present in the international scene of cardiology with its large-scale trials, jointly sponsored by the Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) and by Istituto Mario Negri- Consorzio Mario Negri Sud.

The GISSI-Prevenzione includes 11,324 patients, recruited by 172 cardiological departments representing up to 2/3 of the structures of the Country National Health Care System. The results of the GISSI trial confirm early epidemiological reports on the protective effect of a diet rich in fish (n-3 PUFA are considered the main active component), and the findings of other much smaller controlled trials, not sufficiently powered to measure the impact of the treatment on cardiovascular and overall mortality. In the GISSI-Prevenzione, an impressive decrease (more than 40%) has been specifically shown on fatal events classified as sudden deaths, which accounts for up to 30% of all CV deaths. It is interesting to note that the exploratory analysis of the same class of events is also suggestive of an important beneficial effect (similar decrease of events in the treated group) of vitamin E.

A further hint on the importance of the findings of GISSI-Prevenzione must be seen in the fact that the beneficial effects of n-3 PUFA have been obtained in a population already maximally protected with recommended secondary prevention treatments (antiplatelet drugs, beta-blockers, ACE-inhibitors), and exposed to a mediterranead diet, which has been confirmed recently to be per se an important protective factor with respect to cardiovascular risks.

Based on the estimates produced by GISSI-Prevenzione, up to 20 lives are expected to be saved per 1,000 pts treated with n-3 PUFA. This 5.7 lives saved per year is a result which compares well with the benefit obtained with statins in the LIPID trial (5 lives / 1,000 pts/yr). The suggested, though statistically not proven benefit of 14 lives saved per 1,000 pts treated with vitamin E is definitely worth of verification.

http://www.gissi.org/Egissip/T_Risultati.php

Mixed results from GISSI-HF heart failure trial
No benefit from statins, but n-3 PUFA (fish oil supplement) more encouraging
Topics: Heart Failure (HF)
Date: 01 Sep 2008
Unexpected results from a large Italian study suggest that patients with heart failure should not be started on statins. The GISSI-HF trial found that rosuvastatin had no effect on clinical outcomes in patients with chronic heart failure of any cause. A separate arm of the same study found that a simple fish oil supplement can benefit patients with heart failure.

Gianni Tognoni, right and Luigi Tavazzi presenting results from GISSI-HF trial. The study was also reported by the LancetPresenting the data at yesterday’s Hot Line session, Professor Gianni Tognoni (Consorzio Mario Negri Sud) said that the results back up those from the recently published CORONA study. Because the two major studies concur, he said, “it is clear that statins cannot be considered to improve clinical outcome in patients with chronic heart failure, of any age, aetiology or systolic function level.”

However, for those with heart failure who are already receiving the drugs, the decision to continue treatment, he said, should be left to the informed judgement of the physician.

Tognoni stressed that the GISSI-HF results were neutral rather than negative and that patients on rosuvastatin did not suffer harm. Safety data were “reassuring”. Nevertheless, discussant Philip Poole-Wilson said that heart failure patients already on the drugs should “probably” have them withdrawn.

The study, which was simultaneously published online by the Lancet, included 4574 patients with chronic heart failure (New York Association class II to IV), irrespective of cause and left ventricular ejection fraction. They were randomised to receive either placebo or rosuvastatin (10 mg daily) and followed for a median of 3.9 years. No differences between the groups were found in the primary endpoints: time to death, or the composite of time to death and admission to hospital for CVD.

Lowered concentrations of LDL and C-reactive protein were found, but these pharmacological effects did not translate into clinical benefit.

Poole-Wilson said that the study had a strong rationale. Observational studies and meta-analyses had predicted a positive outcome: “There were even those who said the CORONA study, and possibly this study, were unethical because it was so obvious that statins would be beneficial. They were wrong, and this is an unexpected result, which
makes us think again. It will have a considerable impact on our thoughts on the pathophysiology of heart failure.

A separate arm of the same study found that a simple fish oil supplement can benefit patients with heart failure. Patients given a supplement of n-3 polyunsaturated fatty acids (n-3 PUFA, 1 g daily) saw an 8% reduction in their relative risk of mortality and admissions to hospital for cardiovascular reasons.

The benefit was moderate and smaller than expected - the study had assumed a 15% reduction in relative risk. However, it was achieved in a population which was already well treated with recommended therapies. In absolute terms, it means that 56 patients need to be treated for 3.9 years to avoid one death.

Presenting the results at yesterday’s Hot Line session, Professor Luigi Tavazzi (Pavia, Italy) said the n-3 PUFA treatment is “moderately effective, safe and cheap, a once-daily administration”.

Discussant Michel Komajda pointed out that the “modest benefit” of supplementation took time to have an effect: mortality curves for treated and placebo groups only started to diverge after two years of follow-up. But he added that the benefit was statistically significant and at present physicians have little further to offer patients with heart failure. “I am sure that those of us who have responsibility for drawing up the next CHF guidelines will pay a lot of attention to the results of this trial,” he said.

http://www.escardio.org/congresses/esc2008/news/Pages/Mixed-results-GISSI-HF-heartfailure-trial.aspx

NCE exclusivity is actually 8 years from the date of approval,
7.5 years of NCE exclusivity + 6 months of pediatric exclusivity,

"If an application submitted under [FDC Act § 505(b)] for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under [FDC Act § 505(b)], is approved after September 24, 1984, no [ANDA] may be submitted under [FDC Act § 505(j)] which refers to the drug for which the [FDC Act § 505(b)] application was submitted before the expiration of five years from the date of the approval of the application under [FDC Act § 505(b)], except that [an ANDA] may be submitted under [FDC Act § 505(j)] after the expiration of four years from the date of the approval of the [FDC Act § 505(b)] application if it contains a [Paragraph IV certification]. The approval of such [ANDA] shall be made effective in accordance with [FDC Act § 505(j)(5)(B)] except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the [NCE NDA], the thirty-month period referred to in [FDC Act § 505(j)(5)(B)(iii)] shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the [NCE NDA]."

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/01/when-is-5-year-nce-exclusivity-less-than-5-years.html

Raf, you should drop it. You are just continuing your "bring nothing to the table style" and make it even worst.

My TG is 149 and was able to get a script. You should have no problem.

With the coupon, you'll pay $9/month.

Interesting read of the Judge's thinking on the Depomed case,

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/09/court-upends-fdas-clinical-superiority-requirement-for-granting-orphan-drug-exclusivity-decision-lea.html

Thanks. Motley Fool is one step above Sierra World, .i.e, garbage stuff.

What's "MF"? TIA.

HD,

"District Judge Randolph Moss questioned how the agency could reason that the phrase “active ingredient” could have different meanings in different sections of the act. He pointed to a portion of the statute that referred to drugs with multiple separate active ingredients applying for generic approval."

Is that your argument with the NCE case? Seems like the judge think along the same line as well.

Order of Importance, IMO,

1) patent estate holding up against infringement
2) REDUCE-IT trial success
3) getting NCE
4) ANCHOR approval

again, JMHO.

BB, regarding the NCE case, we know 2 things,

1) Amarin's attorney is better and more motivated than the FDA attorney.

2) The judge might not be impartial since he and the FDA ultimately answer to the same boss.

So the NCE decision is at best a coin toss. But I have tremendous confidence in Amarin's patent estate and JT shares the same opinion.

For those who short this stock, answer a simple question:

Who's more informed about the future prospect of Amarin? You or the Baker Brothers?

Independent Data Monitoring Committee Unanimously Recommends Unblinding of IMBRUVICA® (ibrutinib) Phase III Combination HELIOS Trial Based on Interim Analysis Showing Significant Improvement in Progression-Free Survival in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

http://finance.yahoo.com/news/independent-data-monitoring-committee-unanimously-190000090.html

Amarin's REDUCE-IT trial next?

Freak, JL's post did not mention or imply "sell" at all. Why you reply to him with such a meaningless post. As a moderator, you should know better and set a better example for this board.

Already traded over 10 times average daily volume before 11:00 am. If this can close near the high of the day, then it has accomplished a feat that I haven't seen before in over 20 years of trading, hence the probability is low for such to occur. No matter what, given JT's confidence in the CC and BB's involvement, our future is never brighter

There is nothing to settle on the NCE case. Amarin says yes but FDA says no. I don't see any middle ground for settlement.

HD, if you look at slide #73, on May 2013 the primary event was tracking pretty close to the projected event. So the main reason for Amarin to bump up the TG requirement in May 2013 was to recruit sicker patients in order to accelerate interim data read out. Do you agree?

If the composite event rate is 5.2%, then the placebo group event rate should be around 5.62% for an expected 15% risk reduction in the Vascepa arm. Do I have the correct interpretation? TIA.

Raf, this is 95% BB. Probability of leak or BO is less than 5%.
BB is the god/warren buffet/george soros/peter lynch of small/midcap biotech investing. The private placement is essentially 100% BB private equity financing. The sequence of events is:

BB investment news -> investment community digest the news and piggy back BB -> short covering -> momentum trader pile on -> more short covering, etc.

BB could have invested $40M in hundreds of other beat-up smallcap biotechs but they chose Amarin. Think about it.

If Monday we get similar stock movement, i.e., stock up over 20% on 10 times average daily volume, then I'll conclude that there is a material leak and very positive development to the stock price in the very near future.

In my over 20 year of stock market involvement, I have never seen a stock go up over 20% on 10 times average daily volume 3 days in a row.

Up 22% on 13 times average daily volume today compared with up 23% on 10 times average daily volume yesterday. All I have to say is,

Thank you Baker Brothers.

HD, thanks for getting back to me. Do you agree that on May 2013, R-I is still tracking to 5.2% event rate?

Looking at slide CO-73 again, primary events was occurring at the projected 5.2% rate when they increased the TG requirement to greater than 200. Once they have R-I substantially enrolled (over 4k) and able to file ANCHOR sNDA, Amarin started to enroll sicker patients in order to accelerate primary events. As a result, the placebo group event rate could be substantially higher than 5.2%. Hence, 2015 interim look highly probable.

Also note that on slide CO-73, you can see the primary events line started to separate from the 5.2% projected line a bit around September 2013. EPA started to work its magic?

Is that JT's slip of his tongue regarding 2015 interim analysis there?

Does anybody remember when R-I increased its TG requirement to 200? Is it May 2013 or March 2013?

I know. That's why the $40M investment from the Baker Brothers is such a golden seal of approval. You can't find a better endorsement than that.

SunTrust says $6, Wainwright says $10, Baker Brothers drops $40M and the stock up 23% on over 10 times average daily trading volume.
You JT is a heck of a CEO.

STS, SLXP got bought out recently too.

Please remind me in which post you made such call. TIA.

The prowess of the Baker Brothers,



"Julian Baker and Felix Baker‘s Baker Bros. Advisors’ top pick from the end of 2014 has paid off for the fund in a big way in 2015. AbbVie Inc (NYSE:ABBV) announced last night that they will purchase Pharmacyclics Inc (NASDAQ:PCYC) for about $21 billion, paying $261.25 per share in cash and stock. The sale seemingly brings closure to a dynamic 2015 for the stock, and a windfall for Baker Bros., which entered 2015 with a 12.1% passive ownership stake of 9.13 million shares in Pharmacyclics, making it by far the largest shareholder among funds we track. It was also the fund’s largest position."

http://www.insidermonkey.com/blog/baker-bros-advisors-hits-the-jackpot-with-pharmacyclics-inc-pcyc-sale-incyte-corporation-incy-among-funds-other-top-picks-339953/

Thank you FDA for screwing Amarin so royally that allows me to build a large position in the stock at an attractive price.

Thank you Zum for your tireless research on EPA.

Thank you HD for answering all the stupid questions I have.

Thank you JL for your steadfast confidence in the stock when I question my own sanity during the darkest hour.

Thank you AK for ... for ... for ... I don't know, whatever.

HD, if you look at slide #73, on May 2013 the primary event was tracking pretty close to the projected event. Amarin then bump up the TG requirement to "enrich" the population. As a result, I believe the current event rate with the enriched population might be much higher than 5.2%. Hence, early 2016 interim look for R-I with overwhelming efficacy is highly probable.

Stocks over $2.00. Sometimes a stock is a better and safer buy @ $2 than 78 cents given all the updated info. that are presented. Good luck to all die hard long here.