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Reason for failure to mention Vascepa in commercial
invest83838: "at least to me, this infomercial was terrible for Amarin & Vascepa since during the 2 minute commercial she never directly mentions Vascepa"
The commercial then refers to a link (truetoyourheart.com) that doesn't mention Vascepa either. Marketing geniuses I'm telling you.
Maybe it is because once they mention the product, they then have to go through the litany of potentials adverse effects.
Valentine's commercial
Thanks Lemmi
"No resultados finales" is certainly open to interpretation but suggests some results are available.
Should have drum roll before scientific findings released
"I hope that no results would be presented because by the lack of (enthusiastic) promotion, they can't be that good."
"While anything could happen, I think the far likelier scenario is no results because if there were any, they would advertise as such."
Why just the other day I read on this very board what a good job Amarin did keeping a lid on news before REDUCE-IT results were released.
Really, with all the speculation on this board
Raf: "Why does anyone think they're giving any PREPARE-IT results? Where does it say such?"
Well, does anyone really think you get the PI from the REDUCE-IT study to talk about his data; the PI from the CARDIOLINK-9 study to talk about her data; and then throw in the PREPARE-IT PI to twiddle his thumbs for 30 minutes and say, "well we may have some results on our study in the future." Maybe. Could be.
Seems that way. PREPARE-IT 1 likely.
LBIO "My spanish not very good. Does this mean we get a preview of early results on Feb 5th?"
Dr. Rafael Díaz presents PREPARE-IT February 5th
REDUCE-IT PI, CARDIOLINK-9 PI; PREPARE-IT PI (90 minutes)
https://www.sadi.org.ar/novedades/item/1376-webinar-omega-3-y-covid-19
Speaking of off-label use
The prestigious North American researcher Deepak L. Bhatt, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School, presented the primary results of the first trial called VASCEPA COVID-19 CardioLink-9 in humans of a loading dose of "icosapent ethyl" -compound present in Omega-3- in patients with the new coronavirus.
"I am very excited to present the first human trial of an ethyl loading dose of icosapent," Bhatt anticipated in the run-up to the big event. “If this approach is found to be safe and well tolerated, it could serve as a prelude to future trials of this drug using a loading dose at the time of a heart attack or stroke, as well as in patients undergoing urgent procedures such as a stenting and / or bypass surgery.
https://revistaenterate.com.ar/un-prestigioso-cardiologo-de-harvard-revelo-que-el-omega-3-podria-ser-un-posible-tratamiento-para-pacientes-leves-con-covid-19-por-sus-propiedades-antiinflamatorias/
Off-label of approved medicines allowed in Europe
STS - "More than enough people in the EU meet those qualifications for AMRN to succeed, but unlike in the US they won't be able to capture off label but close to on label patients - like me."
https://ec.europa.eu/health/sites/health/files/files/committee/stamp/stamp6_off_label_use_background.pdf
Association of atherogenic dyslipidaemia with all-cause mortality
There were 3,602 deaths over a follow-up 7.42?±?2.05 years (31.0?×?1000 person-years). In the unadjusted analyses, the highest TG:HDL (but not triglyceride) and the lowest HDL cholesterol quartile were associated with increased death rate and mortality risk. When sequentially adjusting for confounders, including total, LDL, or non-HDL cholesterol and lipid-lowering treatment, mortality risk was significantly higher in the highest triglyceride (hazard ratio 1.167 [95% confidence interval 1.055–1.291], p?=?0.003) and TG:HDL (1.192 [1.082–1.314], p?<?0.0001) and the lowest HDL cholesterol (1.232 [1.117–1.360], p?<?0.0001) quartile, though the association of triglycerides and HDL cholesterol disappeared after further adjustment for each other. Interaction with gender was significant only for HDL cholesterol (p?=?0.0009). The relationship with death was stronger for triglycerides in males and HDL cholesterol in females, with these associations remaining significant even after adjustment for HDL cholesterol (1.161 [1.019–1.324], p?=?0.025, for the highest vs the lowest triglyceride quartile) and triglycerides (1.366 [1.176–1.587], p?<?0.0001, for the lowest vs the highest HDL cholesterol quartile).
https://cardiab.biomedcentral.com/articles/10.1186/s12933-021-01224-7
Wrong once again Lizzy.
Post wasn't about insider trading, just that the disclosure of material information to insiders, even if they don't trade on it, is verboten unless the same information is provided to the public at large. I was trying to give you an out for when immediate disclosure is required.
https://www.investopedia.com/terms/r/regulationfd.asp
Maybe should stay away from factual posts like stating "that is a violation" - I mean some people might actually believe you and the next think you know we have an insurrection at Amarin HQ.
Lizzy, that's difference between ethics and the law.
The law says you have 4 days to disclose material information, not that that you should take all four days.
But the law also says, if you are disclosing material information to some insiders, you need to immediately disclose to everyone. So, for instance, once an institutional investor sitting on the Board has been told there is EU approval, then such information must be immediately made public.
Sorry Lizzy, not the way it works.
Any material news has to be disclosed within 4 business days, not just updated information previously reported in quarterly reports. Of course if you have a document that says otherwise, please post.
No, it would not be a violation.
Companies have 4 business days to disclose material events.
https://en.wikipedia.org/wiki/Form_8-K
Looks like jury trial can be demanded
...unless parties agree otherwise (or Court says no right)
RULE 38.1. Notation of "Jury Demand" on the Pleading.
If a party demands a jury trial by endorsing it on a pleading, as permitted by Fed. R. Civ. P. 38(b) , a notation shall be placed in the caption of the pleading stating "Demand For Jury Trial" or the equivalent. This notation will serve as a sufficient demand under Fed. R. Civ. P. 38(b).
(a) When a Demand Is Made. When a jury trial has been demanded under Rule 38, the action must be designated on the docket as a jury action. The trial on all issues so demanded must be by jury unless:
(1) the parties or their attorneys file a stipulation to a nonjury trial or so stipulate on the record; or
(2) the court, on motion or on its own, finds that on some or all of those issues there is no federal right to a jury trial.
https://www.ded.uscourts.gov/sites/ded/files/local-rules/District%20of%20Delaware%20LOCAL%20RULES%202016.pdf
https://www.law.cornell.edu/rules/frcp/rule_39
For those who love Vascepa, but hate Amarin
(Which could be a majority on this board). Edding (or Etten if you prefer) has submitted an application for the Hong Kong Stock Exchange as of last September, with Morgan Stanley and Credit Suisse as joint sponsors. It doesn't appear to have gone through yet.
https://translate.google.com/translate?hl=en&sl=zh-CN&u=http://www.crswim.com/mengzixinwenzhongxin/xinguxinwengunyitengyiyaogangjiaosuozhubandibiao_2019nianshouruchao18yi_870.html&prev=search&pto=aue
While Fidelity allows trades on HKEK, I think each trade through them costs about US $32.
The other way to trade HKEK is to set up an account via Boom. I read that it takes a couple weeks because snail mail of documents required to be sent to Honk Kong. (Probably Fed-Ex allowed).
http://boom.com/en/open_account/
Amarin remains undervalued under almost any scenario
Cowen analyst Ken Cacciatore believes Amarin shares remain undervalued under almost any scenario and said its valuation appears too discounted. He believes the company's best path forward it to cease US promotional spending to maximize profitability and then sell the company for European value, Cacciatore maintained his Outperform rating and $10 price target on Amarin shares.
https://thefly.com/landingPageNews.php?id=3231881&headline=AMRN-Amarin-remains-undervalued-under-almost-any-scenario-says-Cowen
But he hasn't announced it
"The Institutional investors knew ,as did posters of this board ,that amrn had been granted approval in China before Thero announced it."
Putting out a FAQ sheet is not an announcement. That was a SOP to the pesky investors on this board pelting them with questions. So still most people do not know about pilot program approval. If management wasn't afraid of the follow-up questions, (like how much are we charging) they would PR:
"Vascepa Gains approval in Chinese Pilot Program"
and
"First prescription written for Vascepa in China"
If Grace was all that sharp ...
... she would have had Biocryst's berotralstat on her tweet
Hainan FAQ: Provokes more questions than answers
So, did Amarin simply "provide" a pre-license supply or are they getting fairly compensated for it? What happens when the supply runs out and China Mainland still hasn't approved? With Amarin's participation in this "pilot program", will they have real time access to the mandatory data being collected on the Chinese patients? With the lack of a formal PR answering these kinds of questions, I am guessing this is an instance of Big China simply dictating the terms of the deal. I am hoping the pre-license supply is small enough to incentivize a quick Mainland approval. A phase III study was already done with Chinese citizens showing the efficacy and safety of Vascepa.
Amarin "speaks" on Hainan
https://investor.amarincorp.com/static-files/adacf865-646c-46ec-909d-63c4b7ce19ab
First China Vascepa prescription issued yesterday
http://sh.xinhuanet.com/2021-01/20/c_139683425.htm
One medicine, one strategy for each patient
(Gu Gang, Director General of the Boao Lecheng International Medical Tourism Pioneer District Administration, Hainan) With the introduction of the interim measures for drug removal from the park, our patients can take the drug out of the park after the first hospitalization. Of patients in the Mainland of China provide great convenience. Especially for patients with tumors who need to take oral medicines for a long time, they no longer need to buy them abroad, and they are not limited to use in the park, which is a very convenient for the patient's experience.
Jia Ning, director of the Drug Administration of Hainan Province, said that the "Interim Measures" have two obvious characteristics: First, patients must sign a written informed consent and a letter of commitment from the hospital, promising to import clinically needed drugs for personal use only, and cooperate Supervision and monitoring. The second is to implement "one medicine, one strategy" for each patient.
Jia Ning, Director of the Drug Administration of Hainan Province) The interim measures clarified that medical institutions should formulate a discharge plan and emergency plan for each patient based on the actual situation of different patients who need to continue to use clinically-imported drugs. Patients can take away a small amount of oral clinically needed imported drugs for personal use only from the advance zone.
According to the introduction, the implementation of the "Interim Measures" will effectively solve the problem that patients must be hospitalized every time they use clinically needed imported drugs, greatly reducing the cost of medication and making it easier for patients at home and abroad to diagnose and treat.
https://www.tellerreport.com/business/2020-03-29---new-policy-in-boao-lecheng-xiancheng-district--hainan--patients-can-leave-the-park-with-licensed-drugs-chinanews-com-.HJfkVOnTII.html
Couldbe - thanks for the welcome.
First off, am just a schmo to whom nobody should listen. I worked at a DoD medical research facility for years (mostly epidemiological research), picked up a law degree, and then ran the IRB/Data Privacy function for 15 years. Mostly retired now but have done a little VA/Medicare work last couple years.
My entrance into AMRN was rather fortuitous in December. I was researching BCRX, who had a PDUFA date coming up, and started looking at EMA documents, wherein that caused me to look at AMRN. BCRX has had a good run and may have a little more steam with Japan/Europe approvals coming up. I tend to hold stocks longer than I should. Am a long-time ARNA sufferer but 2020 made me grateful I held and bought dips. But still just paper gains at this point.
With regard to AMRN, when I started looking at it on the long Christmas weekend, I felt it was well worth taking a position. So much positive news out of REDUCE-IT, and frankly the fact that AMRN had taken such a hit over the patent issues encouraged me (sorry). That tumbling in SP seemed way over done, and I figured if it was really worth $20 before the IP issue, then it should similarly be worth that much with EU approval and no patent issues there. Plus, I reasoned, institutions that brought the price down in 2020 are probably ready to take it back up to rinse and repeat. PREPARE-IT and China efforts are icing on the cake. As a one-trick pony, AMRN should be appealing to some big pharma. I have lost money on options on other stocks so figured I should give myself an opportunity to lose some here as well. After my Christmas weekend homework, I had orders in for shares and March, April, and June options when market opened the following Monday. I am a small player but easily excitable. And that is the perspective of a pair of fresh eyes on this stock.
I normally post on the Village but am not shilling for them. They are just good for me for posting links, documents, and pictures. Not much activity over there for AMRN (the IV ARNA board is excellent) and thus I sought out IHub. Some very, very good posts on this board and am appreciative to all that contribute.
Cheers!
Come for the beaches, leave with Vascepa
Sorry, about the multiple repeat posts earlier. First time poster, long time fumbler. Thanks to whoever deleted the repeats. Then those multiples exceeded the three posts allowed on your first day, so I was in poster prison until it turned midnight somewhere …
Description
Hainan is an island province of China and the nation’s southernmost point. It's known for its tropical climate, beach resorts and forested, mountainous interior. The southern city of Sanya has many beaches that range from 22km-long Sanya Bay to crescent Yalong Bay and its luxury hotels. Outside Sanya, the hilly hiking trails of Yanoda Rainforest Cultural Tourism Zone pass over suspension bridges and by waterfalls.
Compared to most of mainland China, the air quality of Hainan is far higher since it is not affected by factory pollution, which has adversely affected the air on the mainland. Throughout 2012, Hainan had the highest air quality in the country for 351 days.
On June 1, 2020, a large-scale plan was announced by the Chinese government to transform the entire island province into a free trade port (FTP), with the aim of turning it into the largest special economic zone in China. The island is also China's first blockchain testing zone that was officially started in 2019.
On September 1, the Hainan Provincial People’s Government issued the Integration and Innovation Reform Plan (IIR Plan) for the new Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Medical Tourism Zone).
The Hainan Medical Tourism Zone sits within broader plans to transform Hainan into the world’s largest Free Trade Port, where other industries, such as modern services and high-tech industries, also play a central role.
On September 1, the Hainan Provincial People’s Government issued the Integration and Innovation Reform Plan (IIR Plan) for the new Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Medical Tourism Zone).
Within the plan, the 10 goals are further broken down into 34 specific policy measures. Some of the more notable measures are stated below.
Creating the only ‘global special drug insurance’ in China and innovating payment methods for medical insurance. Multiple advances have already been made to the administration of health insurance in Hainan, including improving health insurance access by way of relaxing the age, occupation, and medical history restrictions as well as eliminating the waiting period, deductible amount, and prerequisite medical examination requirements – which have also served as significant barriers to entry in the past. Under the latest IIR document, the following changes have been made:
- Under the “medical insurance + commercial insurance” mechanism, the domestic unlisted drug will be added to the domestic health insurance;
- A system of “global special drug insurance” will be established, alongside specific reform measures to guide the innovation of payment methods for this medical insurance; and
- Introduce a commercial insurance payment platform to provide plans, such as installment payment for patients’ medication.
Timeline of developments in the Hainan Medical Tourism Zone
Since the medical tourism zone was first developed in 2013, the central and provincial governments have released a number of new policies to make possible the transformation of the Hainan International Medical Zone into a world-class medical tourism destination and medical technology innovation center by 2030.
In September 2019, the Hainan Medical Zone Implementation Plan, also known as the National Nine Articles, first introduced numerous key policies and delegated the authority to approve the import of drugs to the local authorities. The plan had the following effects:
• Allowed in-zone medical institutions to import much needed foreign drugs and medical equipment that are not yet approved by the top drug authority in China.
• Allowed patients to take imported drugs of limited dosage (which have not been registered in China) out of the pilot zone for personal use.
• Allowed research hospitals to collect real-world clinical data from patients using imported drugs and medical devices. The data could be used to expedite the registration and approval process for innovative drugs and medical instruments to enter China.
• Encouraged state-level public hospitals to enter the zone. Three to five public hospitals will be authorized to franchise brand, trademark, and technology to medical institutions in the pilot zone.
• Built an evaluation center for imported drugs and medical devices to facilitate the clinical use of imported drugs and medical devices.
Since then, developments within the Hainan International Medical Tourism Zone have been rolled out quickly – this latest plan marking the third key document released by the Hainan Provincial government just in 2020 alone.
The latest reform plan adds the development of a “global special drug insurance” and implementation of “a full-process pharmaceutical traceability platform” to a growing list of new systems and processes that will be adopted to support the growth of this zone. The most recent document also removes a lot of the red tape that existed for the import of new medical products, the construction of new medical projects, or the licensing of medical institutions and practitioners within the zone.
First approval of Vascepa in China
American cardiovascular drug Vascepa will enter Boao Lecheng
On the morning of January 17, the Vascepa clinical research kick-off meeting in Boao Lecheng Pioneer District was held at Boao Yiling Life Care Center. Liu Zhefeng, Deputy Director of Boao Lecheng International Medical Tourism Pilot Zone Administration; ...
This conference conducted in-depth discussions and exchanges on the research and practical application of Vascepa's real-world data, and jointly discussed the feasible path of Vascepa's clinical data collection and clinical research plan, and developed innovative ideas, unified and efficient actions, and worked together to accelerate the promotion of Vascepa in The domestic approval for listing also provides valuable experience for the regulatory model of innovative drugs and medical devices, allowing more domestic patients with cardiovascular and cerebrovascular diseases to use new, good, and assured drugs
At the meeting, Liu Zhefeng, deputy director of the Boao Lecheng International Medical Tourism Pilot Zone Administration, delivered a speech. He said that as the only "medical special zone" in the country and one of the key parks for the construction of Hainan Free Trade Port, Lecheng Pioneer Zone has always been a test field for bold experiments, bold breakthroughs, and independent reforms.
The implementation of the pilot work for the application of clinical real-world data in Boao Lecheng, Hainan, is to make full use of the advantages of the policy system and mechanism of the Lecheng Pilot Area, and is an extension of the policy of urgently needed imported licensed medicines and devices in Lecheng clinical.
Deng Jianwei, Vice President of Eton Pharmaceuticals, said: "We are pleased to see that Vascepa, a new drug that reduces cardiovascular risk, has been approved for first use. The U.S. Food and Drug Administration (FDA) approved Vascepa as a supplement to the maximum tolerance of statins In order to reduce cardiovascular risk, the introduction of this new drug is another successful practice of the licensing policy of the pilot zone. Looking forward to the future, Eton Pharmaceuticals will continue to introduce innovative drugs into the park at a faster rate, benefiting more Domestic patients."
"Before today's seminar, I have studied for many days and done a lot of homework." Yue Hongwen, director of Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment Center, said with excitement, "At present, Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment The center has established a special medical team to provide guarantee for the smooth implementation of the new drug introduced, and carry out comprehensive collection of patient feedback on clinical use, data statistics, real-world data research, etc. for the optimization of clinical pathways for chronic cardiovascular diseases. I also I very much hope that this new natural medicine, based on statins, can help more patients with chronic cardiovascular diseases, reverse coronary heart disease plaques (soft plaques), reduce the risk of cardiovascular malignant events, and unlock the heart of China A new era in the prevention and rehabilitation of chronic vascular diseases."
The introduction of Vascepa into Lecheng as the drug with the greatest tolerance to statins to reduce the cardiovascular risk of high-risk patients means that Chinese patients will simultaneously share this cutting-edge therapy with patients around the world. Professor Wu Yongjian from Fuwai Hospital of the Chinese Academy of Medical Sciences said that the advent of Vascepa further addresses the urgent need for excellent clinical efficacy in the field of cardiovascular therapy, and can effectively reduce the residual risk of a variety of major cardiovascular adverse events, in order to benefit more Chinese patients.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8066&pt=msg&mid=21582694