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    Amarin - The Science Of Lipid Therapy (Seite 124)

    eröffnet am 03.01.14 20:10:32 von
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     Ja Nein
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      schrieb am 07.11.19 16:38:36
      Beitrag Nr. 610 ()
      Ganz zu Schweigen von 20 % weniger CVD Todesfälle, eine Schande so einseitig zu schreiben, FUD pur😡
      Amarin | 17,30 $
      Avatar
      schrieb am 07.11.19 16:36:55
      Beitrag Nr. 609 ()
      FUD Artikel:

      Mann kann alles schlechreden bzw. schlechtrechnen, Fakt ist, Amarin hat alle primären Endpunkte souverän erreicht und ein Placebo ähnliches Nebenwirkungsprofil.
      Die shorts versuchen alles, big pharma steckt auch dahinter, hoffentlich nicht auch noch die korrupte
      FDA?

      6 Reasons Investors Are Nervous About Amarin's Big Date With the FDA
      A positive outcome from an upcoming FDA advisory committee meeting is far from guaranteed.
      Cory Renauer
      Cory Renauer
      (TMFang4apples)
      Nov 7, 2019 at 6:16AM
      Author Bio
      Follow @@coryrenauer

      Shares of America's favorite fish-oil stock, Amarin (NASDAQ:AMRN), have risen sixfold since the company released surprisingly positive results from the Reduce-It study last September. In a nutshell, the company's only product, a fish-oil capsule called Vascepa, appears to lower the risk of heart attacks for high-risk patients.

      On Nov. 14, the company's proprietary formulation of fish oil will be the subject of an advisory committee meeting at the Food and Drug Administration. Here are six reasons investors are increasingly worried about the outcome of that meeting.
      Man looking at a laptop and biting his thumb

      Image source: Getty Images.
      1. There's a lot on the line

      Vascepa is officially approved for the treatment of a fairly small group of people with dangerously high triglyceride levels. Year over year, third-quarter sales of the drug more than doubled to an annualized $449 million, but the company still lost $0.01 per share.

      Amarin's recent market cap is up around $6 billion -- in anticipation of an enormous sales bump, which won't happen unless the FDA approves an application to expand Vascepa's drug label to include patients at risk of a heart attack and other major adverse cardiovascular events (MACE). The FDA doesn't have to follow advisory committee suggestions, but it usually does. If the panel of independent experts votes against approving Vascepa for high-risk patients, Amarin's shares could lose half their value overnight.
      2. The great unveiling

      Reduce-It was a long-term clinical trial with 8,179 high-risk patients on statin therapy. Patients who added Vascepa to their statin regimen were 25% less likely to experience a MACE than patients treated with a placebo. With these results, approval to treat an enormous group of high-risk patients might seem like a slam dunk. Just below the surface, though, there are several concerns that could delay Vascepa's label expansion indefinitely.

      About a week ahead of advisory committee meetings, the FDA distributes briefing documents that highlight the agency's concerns in detail. Since communications between drugmakers and the agency are confidential, we only know what Amarin has chosen to disclose.

      Amarin received an advance copy of the soon-to-be-unveiled briefing document in October. In an unusual act of transparency, the company described several topics of concern that are likely to be discussed. While there could be more troublesome issues the company forgot to mention, the ones Amarin disclosed are serious enough to make investors sweat.
      A wooden balance beam with rolled-up cash on one side, and blocks reading RISK on the other

      Image source: Getty Images.
      3. Different populations

      Around 70% of patients enrolled in Reduce-It had already suffered their first MACE; within this group, investigators found risk of a second MACE reduced by 27% among patients treated with Vascepa versus a placebo. Unfortunately, Vascepa led to a less exciting 12% relative risk reduction among the patients who hadn't experienced their first MACE yet.

      Genau diese Patientengruppe sollte untersucht werden, so ein Depp!

      The observed difference between the secondary prevention group and the primary prevention group wasn't statistically significant, but it has raised eyebrows. That's because Amarin's seeking approval for all high-risk patients on statin therapy, not just those who have already suffered through their first MACE.
      4. Mineral oil

      Randomized, placebo-controlled studies are the best way to provide evidence of efficacy, but creating a placebo that fools patients and healthcare professionals can be a real challenge. For Reduce-It, Amarin used capsules filled with mineral oil as a placebo, and in hindsight, it was a terrible idea.

      Mineral oil is an old-fashioned laxative that affects the absorption of some drugs, including statins. This could explain why investigators reported slightly increased blood concentrations of low-density lipoprotein (LDL) cholesterol among patients in the placebo group, even though they were continuing their regular statin therapy.

      Although the placebo group's LDL cholesterol increase was probably too small to account for the overall 25% risk reduction in the group treated with Vascepa, we can't be absolutely certain it didn't play an important role without another long outcome study that employs a different placebo.
      5. Bleeding events

      The mineral-oil dilemma is the biggest problem facing Amarin, but it's not the only issue slated for discussion. The advisory panel will also consider the fact that 11.8% of patients taking Vascepa in the Reduce-It study experienced bleeding events, compared to just 9.9% of the placebo group.

      Slightly increased risk of bleeding associated with Vascepa and other fish-oil capsules isn't a new revelation. In light of questionable efficacy results, though, it could be significant.
      Person with eyes closed and fingers crossed

      Image source: Getty Images.
      6. Irregular heartbeats

      During Reduce-It, 3.1% of patients given Vascepa were hospitalized for an irregular heartbeat or atrial fibrillation, compared to 2.1% of the placebo group.

      Fish-oil capsules, including Vascepa, have already been associated with an increased risk of hospitalization due to atrial fibrillation, but a 25% MACE risk reduction is well worth the slightly elevated risk. If the panel questions those efficacy results because of the mineral-oil placebo, though, the FDA could end up asking Amarin for more data.
      The most likely scenario

      Drug approvals are always made with the assumption that the observed benefits outweigh potential risks. The 12% relative risk reduction among people on statin therapy who haven't already experienced their first MACE is not a huge benefit, when measured against the increased risk of atrial fibrillation and bleeding events that come with long-term Vascepa treatment.

      There's a chance that Vascepa will receive the giant indication Amarin has asked for, but more likely than not, the FDA will limit any approval to patients trying to prevent their second heart attack. That would hardly be the end of the world for Amarin, but it would almost certainly result in a severe market beatdown.

      Er erwähnt weder 28 % weniger Schlaganfälle, über 30 % weniger Angina-Pectonis bedingte Krankenhausaufenthalte.......
      Amarin | 17,31 $
      Avatar
      schrieb am 06.11.19 06:58:29
      Beitrag Nr. 608 ()
      Draft für die Adcom Fragen nicht dramatisch wie es scheint:

      Amarin is ready....
      They got an advanced copy of the FDA briefing book, folks!

      Here is Amarin's assessment on the FDA's perspective on the mineral oil...

      Page 39-40 in the Q32019 10Q
      https://investor.amarincorp.com/node/18261/html

      "Based on our current understanding of FDA’s focus and perspectives due in part to our review of an ADVANCED COPY OF A DRAFT of FDA’s EMDAC briefing document received from FDA at the end of October 2019 as part of the agency’s typical procedures, we expect the final FDA EMDAC briefing document and the EMDAC meeting to cover the following topics, among others, related to our REDUCE-IT sNDA, which topics are among the broad range of topics typically explored at FDA advisory committee meetings and cover matters consistent with prior disclosures and available data:

      * analyses related to study conduct and data robustness, quality, integrity and consistency; for example, as previously disclosed, REDUCE-IT was a single clinical trial conducted based on a special protocol assessment (SPA) agreement with the FDA and, as is typical for all CV outcomes studies, related analyses are expected on the overall strength and limitations of study data to support the indications sought, as described above, considering factors including, but not limited to, the use of mineral oil placebo used in the study and questions explored in past FDA reviews and raised publicly since then over the plausibility of an interaction of the placebo with statins that some have argued could have led to reduced absorption of statin medications, which we do not believe occurred for reasons previously disclosed, among others to be presented in our briefing document; but, consistent with the publication of REDUCE-IT results in The New England Journal of Medicine, we believe FDA has assessed that even if plausible based on indirect evidence of a potential effect, that an exploratory analysis indicates the effect, if any, of mineral oil on LDL cholesterol values on the time to the primary endpoint is NUMERICALLY SMALL and UNLIKELY TO CHANGE the overall conclusion of treatment benefit"

      --------
      Now the bearish case has no more merit! haha
      I'm even more confident than ever.
      Amarin | 17,33 $
      Avatar
      schrieb am 05.11.19 16:57:40
      Beitrag Nr. 607 ()
      Goldman Sachs, die DrecKsshorter, haben die Aktie unter Kontrolle seitdem sie das lächerliche KZ US Dollar 17 ausgegeben haben, ich hoffe sie fallen gewaltig auf Ihre Schnauze und verlieren hunderte Millionen, die sie den Amarin Aktionären abknüpfen!
      Amarin | 16,67 $
      Avatar
      schrieb am 05.11.19 16:53:32
      Beitrag Nr. 606 ()
      Der Kurs fällt von vorbörslich US Dollar 18 auf fast US Dollar 16, höchst manipuliert!

      Das wird noch hochvolatil beim Erhalt der Adcom Fragen am 12.11.2019, evtl. werde ich stark nachkaufen!
      Amarin | 16,69 $

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      Avatar
      schrieb am 05.11.19 13:55:12
      Beitrag Nr. 605 ()
      Antwort auf Beitrag Nr.: 61.839.303 von Magnetfeldfredy am 05.11.19 11:33:48Die Q3 / 19 -Zahlen lesen sich doch mehr als gut. :)

      Apropos Zahlen -
      hier eine wirklich sehr gute Übersicht von Sam81 aus dem stocktwits Forum ( Q.zahlen 19 im Vergleich zu den Q.zahlen 18 )


      Amarin | 16,20 €
      Avatar
      schrieb am 05.11.19 11:33:48
      Beitrag Nr. 604 ()
      Amarin EPS beats by $0.05, beats on revenue
      Nov. 5, 2019 5:03 AM ET|About: Amarin Corporation plc (AMRN)|By: Gaurav Batavia, SA News Editor

      Amarin (NASDAQ:AMRN): Q3 Non-GAAP EPS of $0.01 beats by $0.05; GAAP EPS of -$0.01 beats by $0.03.

      Revenue of $112.4M (+103.3% Y/Y) beats by $2.36M.

      Shares +0.6% PM.

      Press Release
      Amarin | 16,50 €
      1 Antwort
      Avatar
      schrieb am 05.11.19 08:38:19
      Beitrag Nr. 603 ()
      Antwort auf Beitrag Nr.: 61.830.312 von bernie55 am 04.11.19 12:31:27Moin,
      endlich die 17 USD geknackt😀
      und ein ganz herzliches dankeschön an alle hier. Ohne euch wäre ich ich nicht darüber gestolpert.
      Amarin | 16,00 €
      Avatar
      schrieb am 04.11.19 12:31:27
      Beitrag Nr. 602 ()
      Antwort auf Beitrag Nr.: 61.570.521 von Magnetfeldfredy am 26.09.19 07:44:03
      Zitat von Magnetfeldfredy: Große Hoffnung für diesen Late Braker:






      Seven Data Presentations Relevant to Vascepa® (Icosapent Ethyl) Capsules and Persistent Cardiovascular Risk to be Presented at American Heart Association’s 2019 Scientific Sessions, November 16 – 18

      Amarin to Webcast Discussion of Presented Data November 18, 4:30 - 5:30 p.m., Eastern Time


      Upcoming Featured Presentations

      Session FS.AOS.01 – Featured Science Population Science, November 16, 7:30 – 7:40 a.m., Eastern U.S. Time
      “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,” – presented by William S. Weintraub, M.D., MedStar Washington Hospital.

      Session FS.MDP.05 – Follow-up of Landmark Trials, Moderated Science Poster, November 17, 4:20 – 4:25 p.m., Eastern U.S. Time
      MDP479, “REDUCE-IT USA: Results from the 3,146 Patients Randomized in the United States,” – presented by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital and Harvard Medical School.

      Session LBS.06 – Late Breaking Science VI: New Frontiers in Lipid Therapy, November 18, 9:00 – 9:10 a.m., Eastern U.S. Time
      “Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides (200 – 499 mg/dL) on Statin Therapy (EVAPORATE study),” – presented by Matthew J. Budoff, M.D., Los Angeles Biomedical Research.


      Other Upcoming Data Presentations

      Presentation Sa1056,
      “Purified Eicosapentaenoic Acid Ameliorates Cardiac Fibrosis and Tissue Inflammation on Spontaneously Hypertensive Rats,” – Giselle C. Meléndez, M.D., Danielle Medina-Hernandez, Adam Pflum, M.D., Vivian Xu, David M. Herrington, M.D., presented Saturday, November 16., 1:30 – 2 p.m., Eastern U.S. Time.

      Presentation Su3237,
      “Improving Appropriate Use Of Omega-3 Fatty Acids In Primary Care: Success Of Online CME,” – Jelena Spyropoulos, Medscape Education, New York, NY; George Boutsalis, David Anderson – presented Sunday, November 17, 12:30 – 1 p.m., Eastern U.S. Time.

      Presentation Mo1016,
      “Influence of Eicosapentaenoic and Arachidonic Acid on Cholesterol Crystal Formation in Membranes under Hyperglycemic Conditions,” – Samuel C.R. Sherratt, B.S., R. Preston Mason, Ph.D. -- presented Monday, November 18, 11:30 a.m. – noon, Eastern U.S. Time.

      Moderated Poster Presentation MDP414,
      “Many Statin Treated Persons with Borderline Triglyceride Levels are at Risk of ASCVD,” – Nathan D. Wong, Wenjun Fan, Sephy Philip, Peter P. Toth, and Craig Granowitz – presented Monday, November 18, 1:20 -1:25 p.m., Eastern U.S. Time.

      http://www.globenewswire.com/news-release/2019/11/04/1940073…
      Amarin | 15,30 €
      1 Antwort
      Avatar
      schrieb am 01.11.19 15:20:25
      Beitrag Nr. 601 ()
      Amarin to Report Third Quarter 2019 Results and Host Conference Call on November 5, 2019

      GlobeNewswire•October 24, 2019

      DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that it will host a conference call with members of Amarin senior management to discuss the company's third quarter 2019 financial results and provide an operational update on Tuesday, November 5, 2019 at 7:30 a.m. ET.

      The conference call will follow the anticipated release of the company's financial results earlier that day.
      https://finance.yahoo.com/news/amarin-report-third-quarter-2…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/amarin-report-third-quarter-2…
      Amarin | 14,80 €
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