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Amarin Corp. plc - der absolute Hit!
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falls Du eine gute Pharma suchst -(A1K051)- kann ich nur empfehlen!
No Comment:
seekingalpha.com/article/...assessment-agreement?source=nasdaq
After Hours:
Emotionen und Psychologie leiten die Börse...
Y M
Y M
Gut gemeinter Hinweis für unsere Sorgenkinder wie Magnetfeldfredy, Cosmictrade, aber ...
L O N G
wie z.B. in:
* longe Leitung
* zuviel verlongt
* zu long gezögert
* long kann das unmöglich gut geh`n
* jetzt longt´s mir aber!
Ich erkenne da doch den ein oder anderen Grundsatzkonflikt
mit einem gesunden operativen Anlageverhalten à la Shorty ....
Chalifmann
L O N G
wie z.B. in:
* longe Leitung
* zuviel verlongt
* zu long gezögert
* long kann das unmöglich gut geh`n
* jetzt longt´s mir aber!
Ich erkenne da doch den ein oder anderen Grundsatzkonflikt
mit einem gesunden operativen Anlageverhalten à la Shorty ....
Chalifmann
www.fool.com/investing/general/2013/10/30/...-drug-approv.aspx
Amarin Reports Third Quarter 2013 Financial Results
3/2013 Net loss: -$48,884 MINUS
3/2013 Loss per share: -$0,29 MINUS
Nine Months Ended September 30: - $150,816 MINUS
Quelle/Source:
www.otcbb.com/asp/..._module.asp?qm_page=36362&symbol=AMRN
After Hours Attempt of the manipulation!
3/2013 Net loss: -$48,884 MINUS
3/2013 Loss per share: -$0,29 MINUS
Nine Months Ended September 30: - $150,816 MINUS
Quelle/Source:
www.otcbb.com/asp/..._module.asp?qm_page=36362&symbol=AMRN
After Hours Attempt of the manipulation!
Emotionen und Psychologie leiten die Börse...
Y M
Y M
All of information in Millions
Emotionen und Psychologie leiten die Börse...
Y M
Y M
Dreckskorrupte FDA und USA:
www.epadruginitiative.com/
www.epadruginitiative.com/
us.rd.yahoo.com/finance/external/pssa/...bmission?source=yahoo
Gelöschter Beitrag.
Einblenden
»
#85 
FDA hat den Antrag nicht angenommen
Meine Meinung - KEINE Verkaufs-/Kaufsempfehlung.
us.rd.yahoo.com/finance/external/pssa/...educe-it?source=yahoo
Schaut's euch auf der yahoo finance Seite an oder direkt bei Amarin.
Gute NEWS...
Gute NEWS...
Endlich gibts was zum freuen und hier ist niemand mehr da?
Die Meldung sollte wenigstens für nen Jubel-Trubel gut sein
Die Meldung sollte wenigstens für nen Jubel-Trubel gut sein
Bin noch voll dabei, jedoch brutal im Minus, heute die Meldung bingt Hoffnung, daß die FDA Ihr korruptes ADCOM überdenkt!
Vascepa ist best in class und wird sich auf kurz oder lang durchsetzen:
Amarin Says U.S. Ruling on Fish Oil Pill Delayed on Trial
By Anna Edney Dec 20, 2013 12:56 PM GMT+0100 - Comments Email Print
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AMRN:US1.59-0.01 -0.63%
* Price chart for AMARIN CORPORATION PLC -ADR. Click flags for important stories.
Amarin Corp. (AMRN) said the Food and Drug Administration delayed ruling on expanded use of its fish-oil pill while the regulator considers the drugmaker’s appeal of a decision requiring a clinical trial showing whether the product improves cardiovascular outcomes.
A decision scheduled for today was postponed indefinitely as the FDA looks at Amarin’s request, the Dublin-based drugmaker said today in a statement.
The FDA approved the prescription-grade omega-3 fatty acid last year to treat severe triglycerides, a measure of fat in the blood. Expanding use of the pill, Amarin’s only product, to less seriously ill patients who have elevated triglycerides would give the drugmaker access to 36 million U.S. customers, or nine times the pool of people with very high levels.
The pill, Vascepa, may generate $28 million in sales this year, according to the average of six analysts’ estimates compiled by Bloomberg.
Amarin said on Dec. 16 that John Thero, the company’s current president, will become chief effective officer on Jan. 1, succeeding Joseph Zakrzewksi, who will retire.
The FDA agreed with Amarin in 2008 that the company needed to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides. The agency rescinded the accord Oct. 29 based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from lowering lipids.
Appeal Ruling
Amarin said today that the FDA will relay its decision on the appeal by Jan. 15. The regulator hasn’t indicated when it will rule on the application to expand use of the drug, the company said.
Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, sought approval for the drug to treat patients with high triglycerides who also are taking cholesterol-lowering statins.
GlaxoSmithKline Plc (GSK)’s fish oil pill Lovaza was approved in 2004 for patients with very high triglycerides. Very high triglyceride levels measure at least 500 milligrams per deciliter. High triglycerides are those from 200 milligrams to 500 milligrams per deciliter.
Stores such as GNC Holdings Inc. (GNC) and Vitamin Shoppe Inc. (VSI) sell non-prescription dietary supplements containing fish oil. It would take 10 to 40 of such omega-3 capsules to equal the pure fatty acid obtained from “wild deep-water Pacific Ocean fish,” according to the company’s website for Vascepa.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Amarin Says U.S. Ruling on Fish Oil Pill Delayed on Trial
By Anna Edney Dec 20, 2013 12:56 PM GMT+0100 - Comments Email Print
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Dec
Feb
Apr
Jun
Aug
Oct
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AMRN:US1.59-0.01 -0.63%
* Price chart for AMARIN CORPORATION PLC -ADR. Click flags for important stories.
Amarin Corp. (AMRN) said the Food and Drug Administration delayed ruling on expanded use of its fish-oil pill while the regulator considers the drugmaker’s appeal of a decision requiring a clinical trial showing whether the product improves cardiovascular outcomes.
A decision scheduled for today was postponed indefinitely as the FDA looks at Amarin’s request, the Dublin-based drugmaker said today in a statement.
The FDA approved the prescription-grade omega-3 fatty acid last year to treat severe triglycerides, a measure of fat in the blood. Expanding use of the pill, Amarin’s only product, to less seriously ill patients who have elevated triglycerides would give the drugmaker access to 36 million U.S. customers, or nine times the pool of people with very high levels.
The pill, Vascepa, may generate $28 million in sales this year, according to the average of six analysts’ estimates compiled by Bloomberg.
Amarin said on Dec. 16 that John Thero, the company’s current president, will become chief effective officer on Jan. 1, succeeding Joseph Zakrzewksi, who will retire.
The FDA agreed with Amarin in 2008 that the company needed to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides. The agency rescinded the accord Oct. 29 based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from lowering lipids.
Appeal Ruling
Amarin said today that the FDA will relay its decision on the appeal by Jan. 15. The regulator hasn’t indicated when it will rule on the application to expand use of the drug, the company said.
Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, sought approval for the drug to treat patients with high triglycerides who also are taking cholesterol-lowering statins.
GlaxoSmithKline Plc (GSK)’s fish oil pill Lovaza was approved in 2004 for patients with very high triglycerides. Very high triglyceride levels measure at least 500 milligrams per deciliter. High triglycerides are those from 200 milligrams to 500 milligrams per deciliter.
Stores such as GNC Holdings Inc. (GNC) and Vitamin Shoppe Inc. (VSI) sell non-prescription dietary supplements containing fish oil. It would take 10 to 40 of such omega-3 capsules to equal the pure fatty acid obtained from “wild deep-water Pacific Ocean fish,” according to the company’s website for Vascepa.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Hier kann jeder sehen wie die FDA Amarin verarscht hat:
www.epadruginitiative.com/
www.epadruginitiative.com/
yottafire.com/2013/12/...drug-targets-key-role-triglycerides-2
Die FDA wird reagieren und eine Zulassung für Amarin geben mit bestimmten Label, ansonsten wird die FDA verklagt werden, die korrupten Drecksäcke!
Die FDA wird reagieren und eine Zulassung für Amarin geben mit bestimmten Label, ansonsten wird die FDA verklagt werden, die korrupten Drecksäcke!
BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 21, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement."
In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa(R) (icosapent ethyl) 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease.
Prior to being able to appeal DMEP's October 2013 decision to rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP first be given a formal opportunity for reconsideration. With that step now completed, Amarin plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II (ODE-II), the next level under FDA dispute resolution guidance. Based on information available to Amarin, Amarin does not expect a determination on the pending ANCHOR supplemental new drug application (sNDA) while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
As previously stated, Amarin recognizes the significant challenge it faces in its efforts to reinstate the ANCHOR SPA agreement and obtain approval of the ANCHOR sNDA. There can be no assurance that Amarin will be successful in its effort to reinstate the ANCHOR SPA agreement or obtain a label expansion reflecting the ANCHOR clinical trial. There also can be no assurance that the FDA will not communicate the results of its review of the ANCHOR sNDA prior to the timing expected.
Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia.
Conference call today
Members of the Amarin management team will host a webcast and conference call to provide a company update and discuss the recent FDA action today at 8:00 a.m. ET.
In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa(R) (icosapent ethyl) 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease.
Prior to being able to appeal DMEP's October 2013 decision to rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP first be given a formal opportunity for reconsideration. With that step now completed, Amarin plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II (ODE-II), the next level under FDA dispute resolution guidance. Based on information available to Amarin, Amarin does not expect a determination on the pending ANCHOR supplemental new drug application (sNDA) while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
As previously stated, Amarin recognizes the significant challenge it faces in its efforts to reinstate the ANCHOR SPA agreement and obtain approval of the ANCHOR sNDA. There can be no assurance that Amarin will be successful in its effort to reinstate the ANCHOR SPA agreement or obtain a label expansion reflecting the ANCHOR clinical trial. There also can be no assurance that the FDA will not communicate the results of its review of the ANCHOR sNDA prior to the timing expected.
Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia.
Conference call today
Members of the Amarin management team will host a webcast and conference call to provide a company update and discuss the recent FDA action today at 8:00 a.m. ET.
www.statnews.com/2018/09/24/...t-for-cardiovascular-patients/
einfach nur geil, bin über Nacht um 10 mille reicher.
Dann gönne ich mir mal einen Champus. Ausdauer lohnt sich.
Dann gönne ich mir mal einen Champus. Ausdauer lohnt sich.
bei Eröffnung rein zu springen?
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Neueste Beiträge aus dem Amarin Forum
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4 | 539 | AMARIN CORP. PLC REG.SHS(SP.ADRS NEW)/1 LS-,50 (WK | MasterbrokerUSA | Vassago | 04.03.24 17:42 | |
| 3 | 99 | Amarin Corp. plc - der absolute Hit! | JoWu81 | Frozenfrog | 24.04.21 23:41 |
