Ampio Pharmaceutical (AMPE) noch investieren ? - 500 Beiträge pro Seite
eröffnet am 13.05.14 18:32:23 von
neuester Beitrag 08.08.18 06:50:21 von
neuester Beitrag 08.08.18 06:50:21 von
Beiträge: 18
ID: 1.194.356
ID: 1.194.356
Aufrufe heute: 0
Gesamt: 3.180
Gesamt: 3.180
Aktive User: 0
ISIN: US03209T1097 · WKN: A1JGFU
0,0596
EUR
-4,03 %
-0,0025 EUR
Letzter Kurs 04.10.22 Tradegate
Werte aus der Branche Pharmaindustrie
Wertpapier | Kurs | Perf. % |
---|---|---|
0,5700 | +55,23 | |
5,4500 | +41,56 | |
1,1500 | +34,98 | |
1,0000 | +33,33 | |
6,5900 | +31,80 |
Wertpapier | Kurs | Perf. % |
---|---|---|
29,40 | -16,95 | |
5,2500 | -19,23 | |
1,2700 | -19,62 | |
2,0150 | -21,29 | |
2.849,50 | -83,34 |
.
http://ih.advfn.com/p.php?pid=staticchart&s=A%5EAMPE&p=0&t=1…
Citi Grup kursziel 21 $
.
http://www.americanbankingnews.com/2014/05/10/ampio-pharmace…" target="_blank" rel="nofollow ugc noopener">http://www.americanbankingnews.com/2014/05/10/ampio-pharmace…
in D. noch kein Handel
.
http://www.onvista.de/aktien/kurse.html?ID_OSI=29410038
Antwort auf Beitrag Nr.: 46.973.460 von gerdass am 13.05.14 18:32:23
Gerdass covert Unternehmen mit einem Kurs ohne 0 vor dem Komma.
Shame on You!!
Geh ma zum Arzt.
Gruß
P.
Gerdass covert Unternehmen mit einem Kurs ohne 0 vor dem Komma.
Shame on You!!
Geh ma zum Arzt.
Gruß
P.
Antwort auf Beitrag Nr.: 46.973.554 von Popeye82 am 13.05.14 18:47:48wenn man sehr viel Geld hat
kann man nur in Qualität investieren
jeden Tag 4 bis 5 % ist ok
mein Invest hier ist sechsstellig
kann man nur in Qualität investieren
jeden Tag 4 bis 5 % ist ok
mein Invest hier ist sechsstellig
77 Institutional Holders
15,609,259 Total Shares Held
http://www.nasdaq.com/symbol/ampe/institutional-holdings
15,609,259 Total Shares Held
http://www.nasdaq.com/symbol/ampe/institutional-holdings
Antwort auf Beitrag Nr.: 46.973.776 von gerdass am 13.05.14 19:22:48
Möglich ist "fast" alles -die 4 bis 5% je Tag (vollkommener)Schwachsinn-, aber mit Deiner extensiven SchrottStocksZockVorgeschichte, und Deiner "Strategie", fällt mir das sehr schwer zu glauben.
Gruß
P.
Zitat von gerdass: wenn man sehr viel Geld hat
kann man nur in Qualität investieren
jeden Tag 4 bis 5 % ist ok
mein Invest hier ist sechsstellig
Möglich ist "fast" alles -die 4 bis 5% je Tag (vollkommener)Schwachsinn-, aber mit Deiner extensiven SchrottStocksZockVorgeschichte, und Deiner "Strategie", fällt mir das sehr schwer zu glauben.
Gruß
P.
Antwort auf Beitrag Nr.: 46.974.496 von Popeye82 am 13.05.14 20:59:12mach du dein Ding
was glaubst du
ist das in 3 Wochen noch Schrott
TFERD
was glaubst du
ist das in 3 Wochen noch Schrott
TFERD
Also ich würde das bleiben lassen, und vor allem wenn die Strategie in der Vergangenheit nicht so aufgegangen ist würde daraus lernen und nur dann investieren, wenn der Trend richtig gut ist.
Geduld ist das A&O an der Börse
schau einfach nur in die Pipeline
die kann zu jeder Zeit vorbörslich hochschiessen
schau einfach nur in die Pipeline
die kann zu jeder Zeit vorbörslich hochschiessen
Hallo... jemand investiert?
Phase 3 erfolgreich abgeschlossen. Bei Zulassung könnte der nächste Schub kommen
Antwort auf Beitrag Nr.: 56.530.775 von Wandenfels2 am 22.12.17 16:29:32
bei Ampio Pharmaceuticals, Inc. (AMPE) dürften die Lichter ausgehen:
https://www.sec.gov/Archives/edgar/data/1411906/000114420418…
Regulatory Update
As a pharmaceutical company that operates in the United States, we are subject to extensive regulation by the FDA and other federal, state, and local regulatory agencies. The Federal Food, Drug, and Cosmetic Act, or the FD&C Act, the Public Health Service Act and FDA’s implementing regulations set forth, among other things, requirements for the testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising and promotion of our product candidates. Although the discussion below focuses on regulation in the United States, because that is currently our primary focus, we anticipate seeking approval for, and marketing, our products in other countries in the future. Generally, our activities in other countries would be subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be important differences.
With respect to FDA review of Ampion and our completed and ongoing clinical trials, including the AP-003-A and AP-003-C trials, we have been and expect to continue to be engaged in meetings and correspondence with the FDA about the product, its manufacturing, and the preclinical and clinical testing necessary to support Ampion’s safety and efficacy. We met with the FDA in July 2018 and have received a letter in response thereto. In the letter, the FDA stated that it considers the AP-003-A trial to be an adequate and well-controlled clinical trial that provides evidence of effectiveness of Ampion and can contribute to the substantial evidence of effectiveness necessary for approval of a BLA, but that as a single trial the AP-003-A study alone does not appear to provide sufficient evidence of effectiveness to support a BLA. Despite our belief that the APC-003-C trial design was based on FDA guidance and feedback and consistent with FDA precedent for similar products (in intended use, in origin, and in regulatory pathway), which we reiterated with the FDA multiple times, the FDA does not consider the AP-003-C trial to be an adequate and well-controlled clinical trial. The FDA recommended that we perform an additional randomized trial with a concurrent control group and that we request a Special Protocol Assessment to obtain FDA concurrence of the trial design before beginning the study. We plan to continue to discuss with the FDA the necessity of conducting this additional trial, as we believe the current body of data is sufficient to submit the BLA.
Ampio will also continue to address with the FDA the validation of manufacturing processes and controls for the submission of a BLA for Ampion.
Zitat von Wandenfels2: Phase 3 erfolgreich abgeschlossen. Bei Zulassung könnte der nächste Schub kommen
bei Ampio Pharmaceuticals, Inc. (AMPE) dürften die Lichter ausgehen:
https://www.sec.gov/Archives/edgar/data/1411906/000114420418…
Regulatory Update
As a pharmaceutical company that operates in the United States, we are subject to extensive regulation by the FDA and other federal, state, and local regulatory agencies. The Federal Food, Drug, and Cosmetic Act, or the FD&C Act, the Public Health Service Act and FDA’s implementing regulations set forth, among other things, requirements for the testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising and promotion of our product candidates. Although the discussion below focuses on regulation in the United States, because that is currently our primary focus, we anticipate seeking approval for, and marketing, our products in other countries in the future. Generally, our activities in other countries would be subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be important differences.
With respect to FDA review of Ampion and our completed and ongoing clinical trials, including the AP-003-A and AP-003-C trials, we have been and expect to continue to be engaged in meetings and correspondence with the FDA about the product, its manufacturing, and the preclinical and clinical testing necessary to support Ampion’s safety and efficacy. We met with the FDA in July 2018 and have received a letter in response thereto. In the letter, the FDA stated that it considers the AP-003-A trial to be an adequate and well-controlled clinical trial that provides evidence of effectiveness of Ampion and can contribute to the substantial evidence of effectiveness necessary for approval of a BLA, but that as a single trial the AP-003-A study alone does not appear to provide sufficient evidence of effectiveness to support a BLA. Despite our belief that the APC-003-C trial design was based on FDA guidance and feedback and consistent with FDA precedent for similar products (in intended use, in origin, and in regulatory pathway), which we reiterated with the FDA multiple times, the FDA does not consider the AP-003-C trial to be an adequate and well-controlled clinical trial. The FDA recommended that we perform an additional randomized trial with a concurrent control group and that we request a Special Protocol Assessment to obtain FDA concurrence of the trial design before beginning the study. We plan to continue to discuss with the FDA the necessity of conducting this additional trial, as we believe the current body of data is sufficient to submit the BLA.
Ampio will also continue to address with the FDA the validation of manufacturing processes and controls for the submission of a BLA for Ampion.
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