Amarin Corp. plc - der absolute Hit!
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| Eröffnet am: | 03.07.12 21:53 | von: JoWu81 | Anzahl Beiträge: | 100 |
| Neuester Beitrag: | 24.04.21 23:41 | von: Franziskauve. | Leser gesamt: | 31.312 |
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Wertpapier: Amarin Corp |
No Comment:
http://seekingalpha.com/article/...assessment-agreement?source=nasdaq
After Hours:
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
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Wertpapier: Amarin Corp |
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:
http://www.otcbb.com/asp/..._module.asp?qm_page=36362&symbol=AMRN
After Hours Attempt of the manipulation!
http://www.epadruginitiative.com/
Moderation
Zeitpunkt: 22.11.13 13:25
Aktion: Löschung des Beitrages
Kommentar: Löschung auf Wunsch des Verfassers - (veraltete Meldung)
Zeitpunkt: 22.11.13 13:25
Aktion: Löschung des Beitrages
Kommentar: Löschung auf Wunsch des Verfassers - (veraltete Meldung)
Gute NEWS...
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| Boardmail an "biotech1x1" |
Wertpapier: Amarin Corp |
Die Meldung sollte wenigstens für nen Jubel-Trubel gut sein
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Wertpapier: Amarin Corp |
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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* 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
http://www.epadruginitiative.com/
Die FDA wird reagieren und eine Zulassung für Amarin geben mit bestimmten Label, ansonsten wird die FDA verklagt werden, die korrupten Drecksäcke!
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.
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Wertpapier: Amarin Corp |
Dann gönne ich mir mal einen Champus. Ausdauer lohnt sich.
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