Amarin - The Science Of Lipid Therapy (Seite 123)
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ISIN: US0231112063 · WKN: A0NBNG · Symbol: EH3A
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Antwort auf Beitrag Nr.: 61.900.847 von bernie55 am 12.11.19 14:14:19ja sehr gut🙂🙃🙂
jetzt nur noch bis Jahresende ein positiver Bescheid der FDA
jetzt nur noch bis Jahresende ein positiver Bescheid der FDA
Antwort auf Beitrag Nr.: 61.900.829 von bernie55 am 12.11.19 14:12:00
...mehr als gut.
Zitat von bernie55:Fragestellung sieht
doch sehr gut aus...
doch sehr gut aus......mehr als gut.
Antwort auf Beitrag Nr.: 61.900.814 von bernie55 am 12.11.19 14:09:49 Fragestellung sind doch sehr gut aus...
Fragestellung sind doch sehr gut aus...
Fragen von ADCOM sind raus
VOTE:
Has the applicant provided sufficient evidence of efficacy and safety to support the approval of Vascepa for an indication to reduce the risk of cardiovascular events?
a. If yes, provide your recommendations regarding the indicated population and components of the primary endpoint to include in labeling.
b. If no, provide your rationale and comment on what additional data would be needed to support approval.
https://www.fda.gov/advisory-committees/november-14-2019-mee…
VOTE:
Has the applicant provided sufficient evidence of efficacy and safety to support the approval of Vascepa for an indication to reduce the risk of cardiovascular events?
a. If yes, provide your recommendations regarding the indicated population and components of the primary endpoint to include in labeling.
b. If no, provide your rationale and comment on what additional data would be needed to support approval.
https://www.fda.gov/advisory-committees/november-14-2019-mee…
ADVISORY COMMITTEE MEETING
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Date:
November 14, 2019
Time:
08:00 AM - 05:00 PM EST
LINK Conference:
https://www.fda.gov/advisory-committees/november-14-2019-mee…
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Date:
November 14, 2019
Time:
08:00 AM - 05:00 PM EST
LINK Conference:
https://www.fda.gov/advisory-committees/november-14-2019-mee…
Trading Spotlight
Antwort auf Beitrag Nr.: 61.890.437 von bernie55 am 11.11.19 13:34:33Deepak L. Bhatt, MD, MPH
Executive Director of Interventional Cardiovascular Programs
Professor, Harvard Medical School
Cardiovascular Medicine
Executive Director of Interventional Cardiovascular Programs
Professor, Harvard Medical School
Cardiovascular Medicine
Amarin: Matters Of The Heart
Nov. 12, 2019 5:30 AM ET
Summary
The recommendation as the standard of care by the American Diabetes Association and the American Heart Association is paying off in terms of strong sales growth.
The company is doubling its sales force from 400 to 800 professionals by early 2020. I believe this will aggressively ramp up sales in the next few quarters.
The biggest catalyst to catapult Amarin shares to a new high is the upcoming supplemental new drug application (sNDA) for Vascepa.
https://seekingalpha.com/article/4305633-amarin-matters-hear…
Nov. 12, 2019 5:30 AM ET
Summary
The recommendation as the standard of care by the American Diabetes Association and the American Heart Association is paying off in terms of strong sales growth.
The company is doubling its sales force from 400 to 800 professionals by early 2020. I believe this will aggressively ramp up sales in the next few quarters.
The biggest catalyst to catapult Amarin shares to a new high is the upcoming supplemental new drug application (sNDA) for Vascepa.
https://seekingalpha.com/article/4305633-amarin-matters-hear…
Mal schauen was uns die korrupte FDA beschert............
Antwort auf Beitrag Nr.: 61.890.437 von bernie55 am 11.11.19 13:34:33Amarin to Present at the Jefferies 2019 London Healthcare Conference
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present a general company update at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019, at 8:40 a.m. Greenwich Mean Time (GMT) / 3:40 a.m. Eastern Time (ET) in London, UK.
A live audio webcast of the presentation will be available at: http://www.amarincorp.com, and will be accessible at the same link for 30 days.
https://finance.yahoo.com/news/amarin-present-jefferies-2019…
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present a general company update at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019, at 8:40 a.m. Greenwich Mean Time (GMT) / 3:40 a.m. Eastern Time (ET) in London, UK.
A live audio webcast of the presentation will be available at: http://www.amarincorp.com, and will be accessible at the same link for 30 days.
https://finance.yahoo.com/news/amarin-present-jefferies-2019…
REDUCE-IT® USA Results, in Prespecified Subgroup Analyses of Landmark REDUCE-IT Global Study, Showed Robust Cardiovascular Risk Reductions Across a Variety of Study Endpoints, Including Cardiovascular Death and All-Cause Mortality
Mon November 11, 2019 6:30 AM|GlobeNewswire
EPS of $-0.01 beats by $0.04 Revenue of $112.41M (103.18% Y/Y) beats by $2.36M
Prespecified Analysis of 3,146 Patients in the USA Enrolled in REDUCE-IT Showed 31% Relative Risk Reductions for First Occurrence of Both 5-Point MACE and 3-Point MACE
Significant Reductions Shown in All Predefined Composite and Individual Cardiovascular Endpoints, Including Cardiovascular Death and All-Cause Mortality
Tolerability and Safety Findings Consistent with Full Study
https://seekingalpha.com/pr/17693881-reduce-usa-results-pres…
Mon November 11, 2019 6:30 AM|GlobeNewswire
EPS of $-0.01 beats by $0.04 Revenue of $112.41M (103.18% Y/Y) beats by $2.36M
Prespecified Analysis of 3,146 Patients in the USA Enrolled in REDUCE-IT Showed 31% Relative Risk Reductions for First Occurrence of Both 5-Point MACE and 3-Point MACE
Significant Reductions Shown in All Predefined Composite and Individual Cardiovascular Endpoints, Including Cardiovascular Death and All-Cause Mortality
Tolerability and Safety Findings Consistent with Full Study
https://seekingalpha.com/pr/17693881-reduce-usa-results-pres…
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Amarin - The Science Of Lipid Therapy
