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Ajax, I hope you are not referring to Sierra World Equity (SWE) as one of the two industry publications. SWE, IMO, is the pond scum of biotech research.
HD, we know the event rate at the beginning of the trial was less than 5.2%. We also know that event rate went up after May 2013 due to the increased TG requirement (hence confirms higher TG leads to higher MACE). Now we are tracking to the 5.2% event rate according to management. By definition, the TG over 200 group's event rate must exceed 5.2% for the trial to be able to catch up (like press on the gas pedal too hard to catch up). That also leads to increased confidence from the management as the trial progresses.
I believe the mid-course TG requirement correction makes JL and EPADI's stat-man analysis a bit tricky, IMO. I do have to say AK's lecture to the stat-man is like him teaching Peyton Manning how to read NFL defenses or Lebron James how to play basketball.
Good luck to you tomorrow AK.
Stock up 6% on 18% dilution news with broad market down triple digits. Where are you Ladavis?
No management will hint about dilution during a conference call.
Stock price holding up well despite dilution news. Two conclusions from the dilution news:
1) institutions and accredited investors want in now for good things to come.
2) JT and management want to ensure the company survives. Now I know management and shareholders' interests are aligned. Back when we were trading around 80 cents, I thought there is a chance that management might run the company to ground and hand the Newco to themselves and debtholders. Despite the slight dilution, shareholders are assured to benefit from the fruits of R-I trial results. 82.5% of a smaller pie is better than 0% of a big pie.
Another reason, do a favor for institutions who want to get in the stock now at a discount.
Market like the financing news, pre-market $1.76 bid, $1.80 offer.
From sam81, good script growth
Week ending 27/02: TRx=10,588 NRx=4,820{Last week:9,823&4,357, meaning TRx +7.80%&NRx +10.6%}—SECTOR: TRx +4.3% NRx +5.4%
I am fortunate to own some PCYC. One day, a similar story might be wriiten for our Amarin Corp.
http://www.wsj.com/articles/bidding-war-yields-rich-price-for-biotech-1425602974
Herper, AF, Jenkins, Park, Colman ...
I think I see a pattern.
Mr. John Jenkins' thought on OREX's interim analysis,
http://www.forbes.com/sites/matthewherper/2015/03/05/top-fda-official-says-orexigen-data-unreliable-likely-false/
Do you guys agree that the R-I trial enrollment rate has been in snail pace since last couple quarters? It might due to:
1) expense reduction
2) management has seen the event number/rate and happy/confident with the trial progress and feel no rush/pressure to speed up the enrollment.
Any thoughts?
Dew, does less obese means healthier body which leads to MACE reduction make sense? TIA.
Zum, BB is too busy filing lawsuits against FDA! Just kidding.
Interesting look on CVOT interim analysis,
https://propthink.com/latest-data-bode-well-for-orexigens-weight-loss-drug-contrave/
http://www.nytimes.com/2008/06/24/health/24hear.html?_r=0
Mr. Russert’s heart disease was a mixed picture. Some factors looked favorable. There was no family history of heart attacks. Though he had high blood pressure, drugs lowered it pretty well, said his internist, Dr. Michael A. Newman. His total cholesterol was not high, nor was his LDL, the bad type of cholesterol, or his C-reactive protein, a measure of inflammation that is thought to contribute to plaque rupture. He did not smoke. At his last physical, in April, he passed a stress test, and his heart function was good. Dr. Newman estimated his risk of a heart attack in the next 10 years at 5 percent, based on a widely used calculator.
On the negative side, Mr. Russert had low HDL, the protective cholesterol, and high triglycerides. He was quite overweight; a waist more than 40 inches in men increases heart risk. A CT scan of his coronary arteries in 1998 gave a calcium score of 210, indicating artery disease — healthy arteries do not have calcium deposits — and a moderate to high risk of a heart attack. An echocardiogram in April found that the main heart pumping chamber had thickened, his ability to exercise had decreased slightly, and his blood pressure had increased a bit. Dr. Newman and his cardiologist, Dr. George Bren, changed his blood pressure medicines, and the pressure lowered to 120/80, Dr. Newman said.
Thanks HD. It's the first time I saw such a language in any Amarin press releases,
"Completion of the REDUCE-IT study, if not stopped earlier based on the interim analysis by the independent DMC, is expected in 2017 with published results expected to be available in 2018".
JT said something similar verbally in conference calls or presentations, but to put it on paper in a press release is another matter. That shows lots of confidence regarding interim data.
JT is the worst CEO speaker and presenter I known, but he delivered everything he promised and hinted so far (uphill battle regarding sNDA, cutting cash burn, selling ex-US Vascepa right, etc).
Zum, in the latest Amarin's press release on Feb 26, it contains the following language regarding REDUCE-IT (4th paragraph):
"REDUCE-IT enrollment of an estimated 8,000 patients is expected to be completed in 2015, with a protocol pre-specified interim data analysis of efficacy and safety results at 60% of targeted events anticipated in 2016 by the independent Data Monitoring Committee (DMC). Completion of the REDUCE-IT study, if not stopped earlier based on the interim analysis by the independent DMC, is expected in 2017 with published results expected to be available in 2018."
That shows me increased confidence by Amarin's management regarding interim R-I data not previously shown.
HD, the following is what FDA used as an argument against Vascepa being granted NCE
"a drug product with a single active ingredient may contain multiple active moieties. The identification of the active moieties of a naturally derived mixture depends on how well the mixture can be characterized, whether the component in question is consistently present in the mixture, and whether there is evidence that the component is clinically active."
Do you think this argument is a strong one? TIA.
Eddingpharm is based in China while Kowa is headquartered in Japan. I am glad FDA's corrupt influence and practice do not extend to the Far East. EU and the Americas is another story.
Ignore the short term. Market will always try to frustrate the majority.
JT for President! Sure glad JZ was replaced by him.
$1.5 warrant will be exercised for sure. No need for secondary until interim data.
AMRN trading halt! Any quess?
AK, it's me who called you as_h_le for your unnecessary remarks to one of my post. It must be those max does Crestor that causing your terrible memory.
AK, with Obamacare I believe you could choose other health plans. Any reason why you still sick with Kaiser?
Unlike you, at least he tried very hard to right the wrong.
Amarin is what every good investor and trader looks for every single day, asymmetrical risk. Don't want to jinx it, we are comfortably above the 200-day moving average of $1.33, signalling a major change in trend.
Judging from Epanova's failure to launch, seems like Amarin's patent estate is very strong. I believe it's the unexpected and novel invention of AMR-101 which lowers trig. and other biomarkers without increasing LDL that does the trick. I think we and Amarin got lucky on that one.
Zum. I thought Lovaza has a greater TG lowering effect than Vascepa and since TG=fat in blood, I don't understand what the visual aid is showing?
AK, assume more RI trial participants are taking Crestor than HD's expectation, the event rate to date is still tracking to the expected rate. I'll be more alarmed had the event rate to date still tracking below the expected rate despite the bump in TG requirement from 150 to 200 two years ago. That suggests higher TG leads to higher MACE. It also suggests that Crestor might not be as efficacious as you think,i.e., could single-handedly shift the whole event curve.
AK, 4gms of Vascepa a day could be a life extender. If you live a clean life, perhaps you'll die @ 88 years old instead of 80 with V. If you smoke a pack a day and live at Mickey D's, perhaps you'll die @ 55 instead of 50 with V. That's my hope anyway based on the scientific evidence that Zum and others have pointed out.
I am not going to argue with the smartest one on this board. Hope you'll update your cash flow analysis after the next earning call. Hoping for a 2015 cash burn of no more than 60 million so that JT can hold off dilution or selling off EU Vascepa right decision as late as possible.
Happy with 252 NRx increase.
With 150 NRx increase/week, we get 25000 TRx/week by year end, i.e., cash flow breakeven.
Might have posted before by others,
http://www.jewsnews.co.il/2013/08/27/world-renowned-heart-surgeon-speaks-out-on-what-really-causes-heart-disease/
"Teva Pharmaceutical Industries Ltd.TEVA -0.70% said in a securities filing that an internal investigation has turned up business practices that were “likely” violations of the Foreign Corrupt Practices Act.
The drugmaker had previously said it was looking into “issues” in a number of countries around the world that “could rise to the level of FCPA violations and/or violations of local law,” according to a 2014 securities filing.
The company has said its internal probe began after it received subpoenas and other requests for information related to foreign bribery from the Securities and Exchange Commission and Justice Department starting in 2012. The company’s investigation has since turned up business practices and transactions in Russia, Eastern Europe and Latin America that are “likely” violations of the FCPA and local laws, it said in the recent filing. The drugmaker also said the probe will last through at least 2015."
Teva makes generic Lovaza. That's what Amarin's up against folks.
Higher TG leads to higher MACE?
See REDUCE-IT protocol amendment.
AstraZeneca settles U.S. kickback allegations for $7.9M
AstraZeneca has agreed to pay the government $7.9M to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced. The settlement resolves allegations that AstraZeneca agreed to provide remuneration to Medco Health Solutions in exchange for Medco maintaining Nexium's "sole and exclusive" status on certain formularies. :theflyonthewall.com
Why food with trans fat is still not recommended?
Consuming trans fats elevates your triglyceride levels which then increases your risk of developing atherosclerosis, or hardening of the arteries, according to a study published in "Metabolism" in December 2009. Atherosclerosis subsequently increases your risk for heart attack, stroke, heart disease and Type 2 diabetes.
But FDA said trig bewteen 200-499 is fine. I am so confused.