Bekommt Amarin doch die Zulassung der FDA ? - 500 Beiträge pro Seite
eröffnet am 22.10.13 12:20:18 von
neuester Beitrag 03.01.14 20:55:17 von
neuester Beitrag 03.01.14 20:55:17 von
Beiträge: 11
ID: 1.187.487
ID: 1.187.487
Aufrufe heute: 0
Gesamt: 2.477
Gesamt: 2.477
Aktive User: 0
ISIN: US0231112063 · WKN: A0NBNG · Symbol: AMRN
0,8718
USD
-4,94 %
-0,0453 USD
Letzter Kurs 02:00:00 Nasdaq
Neuigkeiten
15.04.24 · globenewswire  |
Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 08.04.24 · globenewswire |
06.04.24 · globenewswire |
03.04.24 · globenewswire |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 3,5800 | +922,86 | |
| 1,0400 | +48,57 | |
| 0,5400 | +38,46 | |
| 5,4000 | +27,06 | |
| 1,9900 | +26,75 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 5,3700 | -25,93 | |
| 3,0200 | -27,58 | |
| 28,18 | -32,62 | |
| 3,6400 | -38,62 | |
| 0,5660 | -40,42 |
Feedback
Nach Neuen Erkenntnissen der neuen Studie die letzte Woche noch nicht im Panel vorlag, gibt es wohl eine gute Chance das hier doch die Zulassung kommt------
Er Kurs wird sich darauf hin Erhohlen!!!
Quelle:
New Study: EPA Reduces Cardiovascular Events - Enough For Amarin Approval
http://seekingalpha.com/article/...h-for-amarin-approval?sou…
Er Kurs wird sich darauf hin Erhohlen!!!
Quelle:
New Study: EPA Reduces Cardiovascular Events - Enough For Amarin Approval
http://seekingalpha.com/article/...h-for-amarin-approval?sou…
zieht weiter an
+21,09% |
+21,09% |
Also mir ist es lieber das der Kurs hoch läuft.....
das könnte heute richtig hoch gehen ...
12:34:59
02-12-2013 12:00 *DJ Amarin Announces Notification Of Patent Allowances For U.S. Applications 13/685,281, And 13/685,291 Related To Triglyceride Lowering With A Mixture Of Omega-3 Free Fatty Acid In Both The MARINE And ANCHOR Patient Populations
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
December 02, 2013 06:00 ET (11:00 GMT)
Copyright (c) 2013 Dow Jones & Company, Inc.
12:34:59
02-12-2013 12:00 *DJ Amarin Announces Notification Of Patent Allowances For U.S. Applications 13/685,281, And 13/685,291 Related To Triglyceride Lowering With A Mixture Of Omega-3 Free Fatty Acid In Both The MARINE And ANCHOR Patient Populations
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
December 02, 2013 06:00 ET (11:00 GMT)
Copyright (c) 2013 Dow Jones & Company, Inc.
Trading Spotlight
Zum Handelsbeginn ein Aufschlag nach der Meldung. Da hätte gern mehr drin sein können.
Alle Augen richten sich auf ARIA und AMRN wird dabei völlig vergessen + vernachlässigt 
Naja Typischer Herdentrieb...zuerst Interessierts nur die wenigsten dann kommen alle aus den Löchern
Der PDUFA Termin wurde auf mitte Januar verschoben
Passiert sehr selten das die FDA den Termin verschiebt
Schätze diesen Entscheid positiv ein für eine allfällige Zulassung
Bei einer Zulassung liegen hier locker 6 - 10$ drinnen
http://www.google.com/finance?q=NASDAQ%3AAMRN&ei=I4y5UsivEum…
Naja Typischer Herdentrieb...zuerst Interessierts nur die wenigsten dann kommen alle aus den Löchern
Der PDUFA Termin wurde auf mitte Januar verschoben
Passiert sehr selten das die FDA den Termin verschiebt
Schätze diesen Entscheid positiv ein für eine allfällige Zulassung
Bei einer Zulassung liegen hier locker 6 - 10$ drinnen
http://www.google.com/finance?q=NASDAQ%3AAMRN&ei=I4y5UsivEum…
Antwort auf Beitrag Nr.: 45.670.689 von Biotechspezialx am 22.10.13 12:20:18@ Biotechspezialx und Moderatoren
Könntet Ihr den Thread bitte ins Biotech Forum verschieben
Besten Dank + Frohe Weihnachten !
Könntet Ihr den Thread bitte ins Biotech Forum verschieben
Besten Dank + Frohe Weihnachten !
Hat eigentlich jemand Info mehr über die Firma und diese "Fischölpille"
die website ist schon ziemlich dünnhttp://www.amarincorp.com/
und wieso wird eigentlich gleich wieder auf andere Firma/Namen "Vascepa" ausgelagert?
....ist ja allen klar, dass der kurs bei zulassung abgeht
aber die firma hat ein Medikament oder besser gesagt einen einzigen Schuss.
Was noch mehr stirnrunzelt ist, dass sie von aktionären verklagt werden.
Ziemliches roulette.....oder?
die website ist schon ziemlich dünnhttp://www.amarincorp.com/
und wieso wird eigentlich gleich wieder auf andere Firma/Namen "Vascepa" ausgelagert?
....ist ja allen klar, dass der kurs bei zulassung abgeht
aber die firma hat ein Medikament oder besser gesagt einen einzigen Schuss.
Was noch mehr stirnrunzelt ist, dass sie von aktionären verklagt werden.
Ziemliches roulette.....oder?
Amarin Corporation (AMRN)
Amarin focuses on the development and commercialization therapeutic products for the treatment for cardiovascular diseases
Amarin has recently asked the FDA to reinstate the ANCHOR Special Protocol Assessment (SPA) agreement for its Drug Vascepa, which is an already approved drug for an adjunct to diet for reducing triglyceride levels in patients suffering from severe hypertriglyceridemia -- the approval is otherwise known as "the MARINE indication."
The FDA was set to make a decision on whether or not to approve the supplemental new drug application for "the ANCHOR indication" on December 20th of last year, but has chosen first to consider whether to reinstate the SPA designation or not. The ANCHOR indication is for the treatment of patients with high triglycerides (>200 mg/dL and <500 mg/dL) with Mixed dyslipidemia.
This is important for the company as an SPA designation basically entails that if a company executes a trial exactly as it promises it will, and the data is presented as asked for by the FDA, the drug would receive regulatory approval. In this case, receiving ANCHOR approval means the potential to make much more money with the drug.
The FDA is bound to honor an SPA agreement once the Phase III trial is completed, as long as the company has followed the agreed-upon protocol to the letter, and efficacy and safety is shown in the data, as agreed upon with the FDA.
Herein lies the problem with Amarin, and not with the FDA, as many Amarin investors believe. We have continually informed our followers that we were bearish on Amarin because of its poor management. Having the SPA agreement revoked shows us that Amarin did not follow the agreement as guided by the FDA, and/or simply did not know how to properly communicate with the organization; not some "conspiracy" enacted upon by the FDA to cheat Amarin on the behalf of "big pharma" to stop the drug from receiving the ANCHOR approval.
It's also hopeful news for Amarin investors that Joseph S. Zakrzewski has stepped down as company CEO, who has been the main reason for Amarin's failures in our strong opinion -- simply stated, we feel Zakrzewski was a poor CEO.
If Amarin's new CEO John F. Thero conveys the SPA case correctly to the FDA, it's a good chance the agreement will be reinstated, which would lead to eventual approval for the ANCHOR indication. If this turns out to be the case, Amarin should at least double in price from its current valuation.
We feel Amarin is undervalued here, and should be currently valued closer to a $500M market cap, simply on the fact that Zakrzewski is no longer the captain of what has been a sinking ship.
The FDA is expected to make a decision on the reinstatement no later than January 15th of this year.
Quelle: http://seekingalpha.com/article/1926641-small-cap-biopharmas…
Amarin focuses on the development and commercialization therapeutic products for the treatment for cardiovascular diseases
Amarin has recently asked the FDA to reinstate the ANCHOR Special Protocol Assessment (SPA) agreement for its Drug Vascepa, which is an already approved drug for an adjunct to diet for reducing triglyceride levels in patients suffering from severe hypertriglyceridemia -- the approval is otherwise known as "the MARINE indication."
The FDA was set to make a decision on whether or not to approve the supplemental new drug application for "the ANCHOR indication" on December 20th of last year, but has chosen first to consider whether to reinstate the SPA designation or not. The ANCHOR indication is for the treatment of patients with high triglycerides (>200 mg/dL and <500 mg/dL) with Mixed dyslipidemia.
This is important for the company as an SPA designation basically entails that if a company executes a trial exactly as it promises it will, and the data is presented as asked for by the FDA, the drug would receive regulatory approval. In this case, receiving ANCHOR approval means the potential to make much more money with the drug.
The FDA is bound to honor an SPA agreement once the Phase III trial is completed, as long as the company has followed the agreed-upon protocol to the letter, and efficacy and safety is shown in the data, as agreed upon with the FDA.
Herein lies the problem with Amarin, and not with the FDA, as many Amarin investors believe. We have continually informed our followers that we were bearish on Amarin because of its poor management. Having the SPA agreement revoked shows us that Amarin did not follow the agreement as guided by the FDA, and/or simply did not know how to properly communicate with the organization; not some "conspiracy" enacted upon by the FDA to cheat Amarin on the behalf of "big pharma" to stop the drug from receiving the ANCHOR approval.
It's also hopeful news for Amarin investors that Joseph S. Zakrzewski has stepped down as company CEO, who has been the main reason for Amarin's failures in our strong opinion -- simply stated, we feel Zakrzewski was a poor CEO.
If Amarin's new CEO John F. Thero conveys the SPA case correctly to the FDA, it's a good chance the agreement will be reinstated, which would lead to eventual approval for the ANCHOR indication. If this turns out to be the case, Amarin should at least double in price from its current valuation.
We feel Amarin is undervalued here, and should be currently valued closer to a $500M market cap, simply on the fact that Zakrzewski is no longer the captain of what has been a sinking ship.
The FDA is expected to make a decision on the reinstatement no later than January 15th of this year.
Quelle: http://seekingalpha.com/article/1926641-small-cap-biopharmas…
The FDA is expected to make a decision on the reinstatement no later than January 15th of this year
Mal schauen ob bis zum 15. Januar diesbezüglich eine Meldung seitens der FDA kommt.....
Mal schauen ob bis zum 15. Januar diesbezüglich eine Meldung seitens der FDA kommt.....
DurchsuchenBeitrag zu dieser Diskussion schreiben
Zu dieser Diskussion können keine Beiträge mehr verfasst werden, da der letzte Beitrag vor mehr als zwei Jahren verfasst wurde und die Diskussion daraufhin archiviert wurde.
Bitte wenden Sie sich an feedback@wallstreet-online.de und erfragen Sie die Reaktivierung der Diskussion oder starten Sie eine neue Diskussion.
Investoren beobachten auch:
| Wertpapier | Perf. % |
|---|---|
| -1,14 | |
| -0,57 | |
| -0,86 | |
| +0,17 | |
| +0,22 | |
| -1,84 | |
| -2,55 | |
| -2,17 | |
| -0,33 | |
| 0,00 |
Meistdiskutiert
| Wertpapier | Beiträge | |
|---|---|---|
| 172 | ||
| 120 | ||
| 78 | ||
| 58 | ||
| 57 | ||
| 56 | ||
| 54 | ||
| 51 | ||
| 44 | ||
| 40 |
23.01.24 · wO Chartvergleich · Canadian Imperial Bank of Commerce |
| Zeit | Titel |
|---|---|
| 04.04.24 |