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It will be old information if not updated by August 1 I suppose, and it's the info I just copied today from the Amarim europe website https://www.amarincorp.eu. You can verify.
I see your link has a tab for management (https://business-monitor.ch/en/companies/1048093-amarin-switzerland-gmbh/management) that lists rather generic titles like "manager"... and this is for Amarin Switzerland, not Germany... I think they're separate subsidiaries. There is a similar listing at https://www.moneyhouse.ch/en/company/amarin-switzerland-gmbh-2618647891/management
I don't put much faith in these business register sites for having an accurate description of the current management and titles as someone just filled out a form or grabbed data somehow to complete that and it's not necessarily company verified. I can't click through to the linked-in pages, so maybe these titles are listed by these folks themselves?
All the executives are still listed on the Amarin Europe website at https://www.amarincorp.eu/executive-team (scroll down or simply click on OTHER AMARIN EXECUTIVES ARE LISTED BELOW).
Lizzy,
I'm wondering what your source is for this info on Kalb and Maher?
I used Google to translate Amarin's German website at https://www.amarincorp.de/amarin-in-deutschland and none of this is listed there... they only show Thomas Zuther as General Manager, Amarin Germany GmbH.
There has also been discussion questioning why there are only 2 (JT and KM) now shown on the management team at the main corporate website at https://amarincorp.com/management-team.html. My suspicion is this was perhaps just an unintentional omission when tweaking the website to feature the upcoming CEO transition.
If one looks at the Amarin Europe website at https://www.amarincorp.eu/executive-team, which still shows CG as SVP/CMO, and scroll down or simply click on OTHER AMARIN EXECUTIVES ARE LISTED BELOW, you can see the following full listing (which also still shows Kennedy and still shows Kalb as SVP/CFO).
Amarin needs better website coordination between HQ and EU... or do all these changes foretell behind the scenes happenings as speculated?
Introducing select members of the Amarin Corporation Executive Team.
Joseph T. Kennedy, EVP, General Counsel and Strategic Initiatives
Aaron Berg, SVP, Chief Commercial Officer
Rami Daoud, SVP, Corporate Development
Dan S. Dunham, SVP, Chief Pharmaceutical Compliance Officer
Daniela Dos Anjos Hanova, European Head of Human Resources
Rebecca Juliano, PhD, SVP, Clinical Research and Development
Michael W. Kalb, SVP, Chief Financial Officer
Derek Kalinowski, SVP, Commercial Supply Chain and Manufacturing Operations
Steven Ketchum, PhD, SVP, President of R&D and Chief Scientific Officer
Tom Maher, SVP, Chief of Operations, Amarin Pharmaceuticals Ireland, Ltd
Donna Pasek, SVP, Human Resources
I also think CG was doing good work in shepherding Icosapent Ethyl through all the regulatory hoops and more recently promoting its benefits. He is quoted effectively in nearly monthly press releases related to medical affairs, and in June participated in several interviews and posted an article promoting Vascepa while addressing the hidden pandemic of CVD:
June 7: https://www.healtheuropa.eu/vazkepa-icosapent-ethyl-revolutionising-cardiovascular-disease-care/108733/
June 14: https://www.linkedin.com/pulse/dodging-tsunami-craig-granowitz
June 25: https://pharmaphorum.com/views-and-analysis/is-cardiovascular-disease-a-pandemic-hiding-in-plain-sight/
It does seem unusual that he is leaving now. His new company has ~1/3 as many employees and ~ 1/3 the market cap, so maybe less than a lateral move, although they do have a more "robust" pipeline and more for him to work on.
Lexicon Pharmaceuticals appoints Craig Granowitz as Chief Medical Officer
https://seekingalpha.com/news/3722225-lexicon-pharmaceuticals-appoints-craig-granowitz-as-chief-medical-officer?mail_subject=amrn-lexicon-pharmaceuticals-appoints-craig-granowitz-as-chief-medical-officer&utm_campaign=rta-stock-news&utm_content=link-3&utm_medium=email&utm_source=seeking_alpha
Jul. 30, 2021 7:08 AM ETLexicon Pharmaceuticals, Inc. (LXRX), AMRNLexicon Pharmaceuticals, Inc. (LXRX)Amarin Corporation plc (AMRN)By: Preeti Singh, SA News Editor
Biopharmaceutical company Lexicon Pharmaceuticals (NASDAQ:LXRX) has appointed Craig Granowitz as Senior Vice President and Chief Medical Officer, effective August 2, 2021.
Granowitz was previously Chief Medical Officer at Amarin (NASDAQ:AMRN). In the new role, Granowitz will oversee the development of Lexicon's product pipeline. He will be instrumental in building out the medical affairs organization as the company prepares to file a new drug application for sotagliflozin as a therapy for people suffering from heart failure and living with type 2 diabetes.
Now read: Lexicon Pharmaceuticals EPS beats by $0.03, beats on revenue
Perhaps our company was aptly named after a martyr...
(last posts about Saint Amarin... the prayers may be working! Keep them going!)
+++++++++++++++++++++++++++++++++++
SAINT GENESIUS I OF CLERMONT (DIED 660/662)
Roman Catholic Bishop of Clermont
His feast transferred from June 3
Patron of
SAINT PRAEJECTUS OF CLERMONT (625-676)
Roman Catholic Bishop of Clermont
His feast transferred from January 25
Martyred with
SAINT AMARIN (DIED 676)
Roman Catholic Abbot
+++++++++++++++++++++++++++++++++++++++++++++
St. Genesius I of Clermont became Bishop of Clermont against his will in 656. He founded a hospital, abbeys, and hospitals before running away in disguise to Rome. Yet his flock demanded the saint’s return. He died in 660 or 662. St. Genesius was patron of St. Praejectus, born into lesser nobility. St. Praejectus studied under St. Genesius I, whom he succeeded (not immediately) as bishop in 666. St. Praejectus founded churches, hospitals, and monasteries. Political intrigue led to his murder. One Hector, a Frankish nobleman, was accused of various offenses. Authorities arrested, tried, and executed him. One Agritus blamed St. Praejectus for Hector’s execution. Agritus murdered the bishop and St. Amarin, abbot at Volvic monastery, at the monastery on January 25, 676.
More about Saint Amarin
From Google translation of https://www.ville-saint-amarin.fr/histoire/
In the 7th century the monk Amarinus (+ in 674 in Volvic), coming from Luxeuil, founded a convent in a place called “Doroangus” (pasture on the Thur). A small city is created around the convent. At the beginning of the 9th century the valley became the owner of the Abbey of Murbach. The name of Saint-Amarin is mentioned for the first time in 1135. A collegiate church was built between 1050 and 1100 and the canons resided there until their transfer to Thann in 1441. A surrounding wall was erected between 1240 and 1260 leaving the collegiate church outside the walls (site of the current church). A bailiff (Vogt), appointed by Murbach, administered the possessions of the Abbey in the valley from the 9th century until 1789. In Roman times the valley was already a passageway to cross the Vosges via the col de Bussang. In the 12th century, with the opening of the St-Gothard pass,the valley opens up to international trade between Italy and Flanders.
The Thirty Years' War (1618-1648) decimates the population of the valley.
The industrialization of the valley begins in the 18th century, grows in the following centuries and the inhabitants become “worker-peasants” until around the 1950s. Saint-Amarin is the capital of the canton and has 2470 inhabitants.
Historical Description
The town of Saint-Amarin owes its existence to the foundation of a small monastery by Saint Amarin in the 7th century. In the 8th century Charlemagne donated the valley to the abbey of Murbach which transformed the monastery into a chapter. A church was probably erected in the 11th century. The collegiate church dedicated to Saint Amarin is mentioned in 1135. It is known only from a drawing by Hans Klauber representing the city around 1562. Wanting to escape the authority of the abbey, the canons decided to settle in Thann in 1441. They remained owners of the collegiate church and ensured its maintenance until 1632. After the Thirty Years' War, it saw its state of conservation deteriorate little by little. In Saint-Amarin, also outside the enclosure, stood since at least the 13th century the Saint-Martin parish church. From 1478 the cemetery was moved from the collegiate church to the parish church where it still exists, although the church was destroyed in 1809. In 1657 the parish was transferred to the collegiate church and the Saint-Martin church was only used for funerals and on the occasion of certain festivals. In 1756, the old collegiate church, which had become dilapidated, was destroyed and a new parish church was built from 1756 to 1758, dedicated to Saint Project and Saint Amarin on the same site. The choir was not completed until after 1772. The church was consecrated in 1786.
Saint Amarin
In my web searching, I discovered there is a Saint Amarin we can all pray to.
When we eventually realize substantive investment gains, we can plan a pilgrimage to Saint Amarin, a small commune in the Haut-Rhin department in Grand Est in north-eastern France, to offer alms at the lovely Church of Saint Amarin.
Tourism resources to begin planning your trip:
https://www.map-france.com/Saint-Amarin-68550/
https://www.tripadvisor.com/Tourism-g1055932-Saint_Amarin_Haut_Rhin_Grand_Est-Vacations.html
https://www.francethisway.com/places/a/saint-amarin-haut-rhin.php
https://www.france-voyage.com/cities-towns/saint-amarin-27181.htm
https://www.france-voyage.com/travel-guide/saint-amarin-commune-27181.htm
Amarin Connect trademark registered July 9 in Europe
https://euipo.europa.eu/eSearch/#details/trademarks/018385170
shows filing language English, second language German, with filing assistance provided by GRÜNECKER PATENT- UND RECHTSANWÄLTE PARTG MBB in München (Munich).
Certainly related to KM's new digital marketing strategy, launching first in Germany, now seeking to register "Amarin Connect" trademark in USA as well.
Amarin Connect trademark
Again found this post from January 29 European application, following links see "EUTM registeredand published" July 9, 2021, with Jan. 29, 2031 expiry date:
https://euipo.europa.eu/eSearch/#details/trademarks/018385170
(from link in twitter , scroll to end, click "+ info" link)
OptumRX w/BCBS coverage of Vascepa FWIW
Finally got around to checking that our OptumRX pharmacy plan and formulary as part of private employer self-funded Blue Cross Blue Shield plan lists the following for Vascepa, 1 gram cap:
Tier 2 (Mid-range cost, preferred brand name)
Cost: $339.26 (30 day supply, $11.31/day)
OptumRX Home Delivery $911.42 (90 day supply, $10.13/day)
Generic Icosapent Ethyl: $304.36 (30 day supply, $10.15/day)
(no pricing shown for 90 day supply of generic Vascepa)
Most concerning to me, as others have noted, that this major PBM still lists indication as only:
"It is used to lower triglycerides. It may be given to you for other reasons. Talk with the doctor."
When did they change?
This 2019 filing also shows Ernst & Young. I saw another from 2012 showing Deloitte & Touch. And who are the big 3? Didn’t dig further but don’t think E&Y is that new for Amarin.
Adding my thanks to the chorus... Thank you, Marjac for your dedicated efforts on behalf of all shareholders!
Study raises more concerns about the use of combined EPA DHA through supplements
A May 17 story in News Medical Life Sciences covering Viet Le's ACC presentation.
https://www.news-medical.net/news/20210517/Study-raises-more-concerns-about-the-use-of-combined-EPADHA-through-supplements.aspx
Viet Le said that these results raise further concerns about the use of combined EPA/DHA, particularly through supplements.
"Based on these and other findings, we can still tell our patients to eat Omega-3 rich foods, but we should not be recommending them in pill form as supplements or even as combined (EPA + DHA) prescription products," he said. "Our data adds further strength to the findings of the recent REDUCE-IT (2018) study that EPA-only prescription products reduce heart disease events."
How Strength Results Impact Reduce-It article
Sleven, ... credit to SoCal_Trader for first posting this on iHub yesterday post#339945
Always good to refresh so others don't miss it, as it's really excellent at providing clarity for our investment thesis!
The false or misleading rumors may be positive or negative. We should all avoid even the appearance of market manipulation one way or the other, don't you think?
SEC.gov | Updated Investor Alert: Social Media and Investing -- Stock Rumors
While social media can provide many benefits for investors, it also presents opportunities for fraudsters. Through social media, fraudsters can spread false or misleading information about a stock to large numbers of people with minimum effort and at a relatively low cost. They can also conceal their true identities by acting anonymously or even impersonating credible sources of market information.
One way fraudsters may exploit social media is to engage in a market manipulation, such as spreading false and misleading information about a company to affect the stock’s share price. Wrongdoers may perpetuate stock rumors on social media, as well as on online bulletin boards and in Internet chat rooms.
The false or misleading rumors may be positive or negative. For example, in a “pump-and-dump” scheme, promoters “pump” up the stock price by spreading positive rumors that incite a buying frenzy and they quickly “dump” their own shares before the hype ends. Typically, after the promoters profit from their sales, the stock price drops and the remaining investors lose money. In other instances, fraudsters start negative rumors urging investors to sell their shares so that the stock price plummets and the fraudsters take advantage of buying shares at the artificially low price.
Think twice about investing if you spot any of these red flags of investment fraud:
Limited history of posts.
Fraudsters can set up new accounts specifically designed to carry out their scam while concealing their true identities. Be skeptical of information from social media accounts that lack a history of prior postings or sending messages.
Pressure to buy or sell RIGHT NOW.
Take the time to research the stock before you invest. Be skeptical of messages urging you to buy a hot stock before you “miss out” or to sell shares of a stock you own before the price goes down after negative news is announced. Be especially wary if the promoter claims the recommendation is based on “inside” or confidential information.
Thanks jasbg for the suggestion... followed the trail and read many of JL's AMRN msg board posts as far back as this insightful post#294730 (one of many) on 9/2/20 on "Amarin as a long term position".
Thanks for sharing this. Valuable summary! Well worth a listen.
Very positive study IMO... I like how Dr. Bhatt says (from 3:06 to the end, my transcription) "...but we do see this relationship that hopefully future trials will investigate ...whether higher achieved levels of serum EPA really do reduce heart failure, but again for the moment I wouldn't say that the information is actionable, I wouldn't for example just use higher doses of icosapent ethyl to try to reduce heart failure endpoints, maybe in the future such a trial would be warranted, but right now in this work I think it's just hypothesis generating, and more than anything affirms the value to human health of high serum EPA levels, at least when that's achieved by a prescription medicine of icosapent ethyl. You know, whether the same relationship would apply with other drugs or with diet alone and so forth, that we can't comment on from this data set. Though I will point out from diet alone it would be virtually impossible to achieve the level of EPA at which we're seeing this association with less heart failure."
Good point about the low dose in the cited study. The paper I linked however is a useful read, a 2019 review paper, raises questions about interaction of statins and omega-3s, suggesting the EPA may work even better without statin use and pointing out the need for further studies:
These findings suggest that statins may inhibit the cardioprotective effects of n-3 fatty acids. Mechanisms potentially involved in this interaction include (1) statin-induced increase in arachidonic acid levels (ie, the main n-6 fatty acid), thus favoring n-6 fatty acids in the n-3/n-6 interplay, and (2) counteraction at the mitochondria level between statins and n-3 fatty acids.17 Another suggestion is that n-3 fatty acids supplements could be protective in terms of CVD risk only in patients who are n-3 deficient.17 These issues remain to be further elucidated in future trials. Of note, all patients were on a statin in the JELIS14 and the REDUCE-IT trials.8
Thank you for this helpful clarification of what "irrespective of statin use" meant.
Still curious what is known about EPA's efficacy for treating CVD when patients are not on statins.
...with alias born just on 5/1/2021 ... 66 posts in 2 weeks confident of $25-$30 BO and promoting selling options...?
Benefits irrespective of statin use
This April 2019 article in the journal Angiology on The Role of n-3 Fatty Acids in Cardiovascular Disease: Back to the Future notes (emphasis mine):
Furthermore, it has been suggested that statin use may diminish the beneficial impact of n-3 fatty acids on CVD events.[citation: Eussen, SR, et al., Effects of n-3 fatty acids on major cardiovascular events in statin users and non-users with a history of myocardial infarction. Eur Heart J. 2012;33(13):1582–8.] In this context, in post-MI patients participating in the Alpha Omega Trial, daily administration of 400 mg EPA + DHA plus 2 g a-linolenic acid was reported to significantly lower major adverse CV events (by 54%) only in statin nonusers (n = 413) and not in statin-treated patients (n = 3740).
and also:
Of note, all patients were on a statin in the JELIS and the REDUCE-IT trials.
In REDUCE-IT, among the 8179 participants with high CV risk of whom 71% had established cardiovascular disease, 29% comprised a primary prevention cohort, and 58% had type 2 diabetes mellitus (diabetes): the baseline LDL-C levels were well-controlled with statins (median value, 75.0 mg/dL), while triglyceride levels were moderately elevated (median value, 216.0 mg/dL). With a median follow-up of 4.9 years, the primary endpoint was reduced in patients in the IPE group at 17.2% compared with 22.0% in the placebo group (hazard ratio, 0.75; 95% CI 0.68–0.83). Notably in subgroup analysis, the benefit was observed irrespective of initial and attained levels of triglyceride or LDL-C and irrespective of statin use.
Really, why must Vascepa's label require use in conjunction with maximally-tolerated statins which cause these multiple adverse side effects?
ED/low testosterone
Kidney disease
Muscle atrophy
Type 2 diabetes
Impaired Motor Performance
Mitochondrial dysfunction
Cataracts
Acute Renal Failure
Cancer
Liver Dysfunction
Vascepa seems to have a very good safety profile with far fewer harmful side effects (mainly slightly increased AFib, bleeding vs. placebo).
I would hope Amarin is working hard to research & develop and get approval for indications not dependent upon statins.
Concerns about statins and tying Vascepa's label to statin use
Looking to learn more about Nissen led me to this video, cued to just before the speaker questions his praise of statins.
My PCP is discussing statins bc of high HDL and increasing cardiovascular risk growing with age (58).
This video addresses how statistics are manipulated to make ~1% absolute risk reduction appear as a more significant 36% relative risk reduction. Reduce-it (and most drug studies) due likewise.
I looked up the number needed to treat (NNT) for Lipitor and find NNT=100 for this 36% RRR.
Vascepa's NNT is much better for measurable benefit when treating "persistent CVR" RRR on top of Statins.
The linked video and article state undesirable harm from side effects of statins outweigh their benefits. Yet it's a multibillion dollar industry BP has cultivated.
I often wonder: where does Amarin stand in studies to obtain a drug indication for using Vascepa to treat CVD without being a treatment on top of Statins? The label does say for patients on maximally tolerated statins, which supposes it can be RXd w/o statins if physician can show statins are not tolerated. But has the benefit of prescription EPA apart from Statin use for treating CVD been demonstrated yet?
Is Vascepa's approval so closely tied to continued statin use to not make waves with BP? Are proposed EPA+statin combo pills really the way to go? And finally, the video disputes the value of lowering LDL cholesterol for reducing mortality rates, while EPA is promoted as the one omega3 that does NOT raise "bad LDL." It seems like the cardiologists still have a lot of conflicting opinions to resolve. While there may remain disputes about the value of lowering triglycerides or LDL, it would seem the value of reducing & stabilizing coronary plaque as shown by EVAPORATE study is harder to dispute, as is the beneficial role of EPA in reducing inflammation.
While in this post#339612 by Sleven linking Nissui's May 2020 annual report they state they planned to begin supplying Amarin by Fall 2020 (though FDA inspection, approval and contracts were not yet finalized)... it seems to have not happened yet.
(I posted a quote here from Sleven's link but incorrectly stated supply beginning Fall 2021... Nissui meant Fall 2020).
But Nissui's 3Q FY2020 Supplemental Docs from February 5, 2021 notes (slide 26, Initiatives for Fine Chemicals Business):
Expand suppliers of EPA/DHA raw materials in short supply and maximize plant operation
Q. Please tell us about the progress of the overseas export of high-purity EPA in the fine chemicals business.
A. It is scheduled to be inspected by the FDA, but the situation where the FDA cannot come to Japan continues due to the influence of the new coronavirus.
In fact, the story does reference Reduce-it success and correctly identifies the drug as "an Omega 3 derivative - eicosapentaenoic acid, EPA":
The PREPARE-IT study will have its branch of volunteers in Argentina, it has
a solid scientific background to rely on. It is based on the experience of
the REDUCE-IT research , which has already shown that the
administration of an Omega 3 derivative -eicosapentaenoic acid, EPA- in
high concentrations and in patients at high risk of developing vascular
events reduced mortality. And the experimental data further
demonstrated that these agents possess antimicrobial and antiviral
properties.
Referencing older Kycc post#301137, Nissui's capacity can supply about 112,000 scripts per week (assuming "not quite 400 MT" ~ 350 MT per plant x 2), but not all their high purity EPA will go to Amarin (stating "In addition to the existing domestic production, the company will manufacture products for Amarin, but the amount of supply cannot be disclosed.")
Thanks, Sleven... good find! Says Nissui actually has 2 plants for high purity EPA, with somewhat less than 800 metric tons/year capacity, and starts supplying Amarin in Fall 2021. Reposting here as it also addresses North's question in post #339619
Supplying highly-purified EPA to Amarin Corporation
Q. When will the supply to Amarin start?
A. It is scheduled for this fall. It is necessary to conclude contracts with the Corporation and obtain FDA approval, but due to the effect of coronavirus, it is uncertain when the inspection for the approval start.
Q. Do you have any visions in three to five years?
A. Since the population of the United States is larger than that of Japan, and the daily prescription volume of drugs made from high-purity EPA is twice as large in the United States as Japan, the demand will be several times than Japan, if a market like Japan is formulated in United States.
Q. How do you expect the production capacity (MT) of highly-purified EPA and supply amount and share to Amarin Corporation?
A. The production capacity of the high-purity EPA was initially expected to be about 800 MT per year at two plants, including the existing Tsukuba plant and the Kashima pharmaceutical plant. Production capacity will be lower than expected due to stricter standards for pharmaceutical raw material. In addition to the existing domestic production, the company will manufacture products for Amarin, but the amount of supply cannot be disclosed.
KYCC, adding my thanks for this informative post.
I went back and read your prior posts also... very helpful. You've indeed done much valuable research on API! Thanks for sharing again.
Helpful clarification.
Thanks for this reply, and sorry I overlooked your earlier post!
Is Nissui an Amarin supplier?
Nissui developed refined EPA with Mochida, with whom Amarin announced a collaboration in 2018.
From Nissui company history timeline:
March 1987 Applied for approval to manufacture "EPA-E Nissui" together with Mochida Pharmaceutical.
August 1990 Jointly developed EPA drug "Epadel" with Mochida Pharmaceutical.
May 2017 The Pharmaceuticals Plant in Kashima for the Fine Chemicals Business was completed.
Nippon Suisan ("Nissui") has a new fish-oil EPA plant with 420 tons/year in capacity and is currently operating at 50% utilization. The company built the plant with expectations of supplying US-listed biotech firm, Amarin (AMRN US) with EPA for its drug, Vascepa, after the drug's Phase III trials were announced. It now appears like Nissui will have to wait at least two years for the start of its EPA shipments to Amarin.
Existing EPA Suppliers for Amarin Take Priority: At the AHA conference, Amarin's CEO John Thero said that his company would stick with existing suppliers for the meantime, as they have "worked hard" to build up capacity ahead of the favorable "Reduce-It" trial results announced. This is more evidence that Nissui will only begin a supply agreement after Amarin has used up its $1bn worth of EPA supply in its current supply base.
If this data--due to be released by the end of September--shows a better than 15% improvement for patients, Nissui is prepared to supply Amarin with its high purity EPA and has already spent Y9bn ($82m, or 20% of 2 years' worth of capex) to double its EPA production capacity.
$21.80 price estimate nine months ago
What if anything has changed significantly since then (as share price has not)?
Not being sarcastic. Personally, am bullish... added shares today
Amarin currently has 40 posted "Sales Professional" job openings
linked to their website "Careers> Current Opportunities section.
Prothena was established in December 2012 when it separated from Elan Corporation, plc with a substantial portion of its drug discovery platform. Our ordinary shares began trading on the Nasdaq Global Market under the symbol “PRTA” and are currently traded on the Nasdaq Global Select Market.
https://www.prothena.com/about-us/
Prothena Corp. - same board chairman, hopeful stock chart
I noticed that Amarin's Board of Directors Chairman since Jan. 2014, Lars Ekman, has also been Chairman of the Board at Prothena (PRTA) since 2012.
Experiencing a similar 2/3 valuation haircut in 2018, PRTA has more than doubled since Feb. 2021. Hopefully, Lars has the skillset and knowhow to similarly help Amarin navigate out of it's current quagmire and stock price slump.
President Biden Signs Bipartisan Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition
This new summary posted today (https://www.whitecase.com/publications/alert/president-biden-signs-bipartisan-legislation-boosting-generic-and-biosimilar, mentions Amarin and the FDA's granting icosapent ethyl new chemical entity (NCE) exclusivity in 2016:
Historically, the FDA has interpreted "active ingredient (including any ester or salt of the active ingredient)" in the statute to mean "active moiety." Nonetheless, this practice has been questioned by the courts. For example, in the 2015 case Amarin Pharmaceuticals Ireland Ltd. v. FDA, the US District Court for the District of Columbia rejected the FDA's denial of NCE exclusivity to Amarin's Vascepa (icosapent ethyl), finding that the FDA's interpretation of "active ingredient" along the lines of "active moiety" was inconsistent with the relevant statutory provision.7 Rather than appeal the ruling in favor of Amarin, the FDA granted NCE exclusivity to Vascepa in 2016.8 Subsequent cases have not rejected the Amarin decision. The Ensuring Innovation Act thus clarifies the statutory grounds for existing FDA practice concerning exclusivity and keeps in place a regulatory approach that makes it more difficult for pharmaceutical companies to obtain NCE exclusivity periods.
Well, it's a small world after all!
Keep fighting the good fight to make it a more just world!
Not sure if intentional, but I liked the "doggone" simile to my screen name (though it is actually an homage to Zen master Dogen and rotation & move of the "u" in my name Doug)j.
Perspective from "The Trial of the Chicago 7"
After watching The Trial of the Chicago 7 movie Friday night, one moment stuck in my mind is just after former US AG Ramsey Clark's shocking testimony was denied it's hearing by the jury and he whispered to the defense attorney "Start working on the appeal."
I see parallels (albeit flipped political party affiliations) here in a judge either so biased or unethical to be able to see and rule in favor of the truth.
Start working on the appeal!
What happened to Judge Julius Hoffman is also interesting... he never changed, but was widely viewed negatively as incompetent:
Although the judge was able to obstruct his way to declaring the group guilty, in 1970, all of their convictions were overturned by a U.S. Court of Appeals, due largely to Hoffman's radical unfairness toward the anti-war activists. After his apparent incompetence and outright antagonism of the Chicago 7, the judge drew skepticism in his ability to adjudicate effectively or fairly. A 1974 book entitled The Benchwarmers exposed the negative reputation of Hoffman among his colleagues in Chicago, claiming a 78% "Unqualified" rating.
A year before his death, Hoffman was forced into retirement by an executive committee, citing age and poor judgment. Stubborn until the end, the real Judge Hoffman defended the actions depicted in The Trial of the Chicago 7, even extolling his own judicial dignity.
Another Amarin website update...
Amarin is reading this investors hub message board. Following this recent post, they have removed the link to out of date "Downloads" section of website from the bottom of their investors page!
THANK YOU AMARIN for paying attention to investor concerns!
No, it is out of date...if you click "last" it takes you to 2008-2011 posts. You can also filter by year at top and confirm nothing added to this website section since April 2019. It seems to be a useless section of website they can eliminate... the FAQ and Press Release sections are kept up to date fine. It's access by scrolling to bottom of investors page and clicking "DOWNLOADS" link in center.