Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 152)
eröffnet am 31.08.08 11:55:05 von
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Letzter Kurs 01.08.23 Nasdaq
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| TitelBeiträge |
|---|
20.07.23 · Business Wire (engl.)  |
30.06.23 · Business Wire (engl.) |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,5800 | +54,90 | |
| 0,7000 | +16,67 | |
| 1,9380 | +16,33 | |
| 1,5000 | +16,28 | |
| 14,390 | +15,12 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 160,90 | -14,14 | |
| 16,100 | -15,26 | |
| 4,0000 | -20,00 | |
| 0,7500 | -35,34 | |
| 2,1000 | -47,50 |
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@Ville
ich bin der gleichen Meinung. Fusilev spielt im Moment keine Geige mehr. Ob die Zulassung in CC kommt oder nicht und auch wann eine Entscheidung fällt ist nicht mehr gewichtig für die Entwicklung von SPPI. Entscheidend wird die Umsatzentwicklung von Zevalin und das Fortschreiten von Eoquin sein.
Auf die Quartalszahlen bin ich gespannt.
ich bin der gleichen Meinung. Fusilev spielt im Moment keine Geige mehr. Ob die Zulassung in CC kommt oder nicht und auch wann eine Entscheidung fällt ist nicht mehr gewichtig für die Entwicklung von SPPI. Entscheidend wird die Umsatzentwicklung von Zevalin und das Fortschreiten von Eoquin sein.
Auf die Quartalszahlen bin ich gespannt.
Antwort auf Beitrag Nr.: 38.808.727 von future_trader am 25.01.10 21:14:23Da kann man nur spekulieren. Ich kann mir vorstellen, wie das Gespräch abgelaufen ist. Die FDA wollte den Nachweis, dass Fusilev gleich wirksam und sicherer oder wirksamer und gleich sicher als Leucovorin ist und hat wohl eine neue Studie vorgschlagen. Spectrum hat dann wohl vehement dagegen argumentiert und erklärt, man könne diese Daten auch aus dem bestehenden Datenmaterial erhalten. Die FDA hat das akzeptiert und die Hürden wohl recht hoch gesteckt. Q3 2010 würde nicht als Zeldatum angegeben werden, wenn Spectrum diese statistische Analysen der bestehenden Daten - und das sind nicht wenige trials als eine sehr schwierige Aufgabe, die vielleicht ein paar statistische Tricks erfordert (und der FDA dann hoffentlich nicht auffällt), sehen würde.
Daher erst Q3 2010. Und daher auch die PM nicht spezifischer. Nur meine Spekulation.
Im Prinzip ist mir das aber egal - Fusilev ist für den Markt ausgepreist. Die entscheidende Story gerade ist Zevalin. Vor einem möglichen Zulassungstermin (Q1 2011) kann auch wieder Fusilev Zulassungsphatasie reinkommen, aber viel früher wohl nicht.
Daher erst Q3 2010. Und daher auch die PM nicht spezifischer. Nur meine Spekulation.
Im Prinzip ist mir das aber egal - Fusilev ist für den Markt ausgepreist. Die entscheidende Story gerade ist Zevalin. Vor einem möglichen Zulassungstermin (Q1 2011) kann auch wieder Fusilev Zulassungsphatasie reinkommen, aber viel früher wohl nicht.
Antwort auf Beitrag Nr.: 38.807.055 von asics01 am 25.01.10 17:50:01Wie soll man das werten?
1) The FDA requested additional data which the Company expects to submit in the third quarter of 2010.
2) The FDA did not request any additional efficacy studies.
Warum erst im 3.Quartal ist mir ein Rätsel??? Keine zusätzlichen Studien ist gut.
1) The FDA requested additional data which the Company expects to submit in the third quarter of 2010.
2) The FDA did not request any additional efficacy studies.
Warum erst im 3.Quartal ist mir ein Rätsel??? Keine zusätzlichen Studien ist gut.
Spectrum Pharmaceuticals Announces Results of FDA Meeting Regarding FUSILEV(R) sNDA under Review for Advanced Metastatic Colorectal Cancer
No Additional Efficacy Studies Needed
Spectrum Currently Expects to Submit Requested Data In Third Quarter 2010
IRVINE, Calif., Jan 25, 2010 (BUSINESS WIRE) -- Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it's supplemental New Drug Application (sNDA) for FUSILEV(R) (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.
The FDA requested additional data which the Company expects to submit in the third quarter of 2010. The FDA did not request any additional efficacy studies.
"We are very encouraged by the collaborative relationship and straightforward requirements for approval posed to us by the FDA," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We currently expect to provide the FDA with the additional data they require to complete their review of FUSILEV for the treatment of advanced metastatic colorectal cancer in the third quarter."
About FUSILEV(R) (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is also indicated after high-dose methotrexate therapy in osteosarcoma. Additionally, FUSILEV is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com.
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for Spectrum's approved drugs, continuing to build Spectrum's team, leveraging the expertise of partners around the world to assist Spectrum in the execution of its strategy, that we expect to submit the additional data in the third quarter, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that Spectrum's existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that Spectrum's existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum's efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum's lack of significant revenues, limited marketing experience, dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. (R) and Fusilev(R) are registered trademarks of Spectrum, TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
SOURCE: Spectrum Pharmaceuticals
Spectrum PharmaceuticalsPaul ArndtSenior Manager, Investor Relations949-788-6700x216
Copyright Business Wire 2010
No Additional Efficacy Studies Needed
Spectrum Currently Expects to Submit Requested Data In Third Quarter 2010
IRVINE, Calif., Jan 25, 2010 (BUSINESS WIRE) -- Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it's supplemental New Drug Application (sNDA) for FUSILEV(R) (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.
The FDA requested additional data which the Company expects to submit in the third quarter of 2010. The FDA did not request any additional efficacy studies.
"We are very encouraged by the collaborative relationship and straightforward requirements for approval posed to us by the FDA," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We currently expect to provide the FDA with the additional data they require to complete their review of FUSILEV for the treatment of advanced metastatic colorectal cancer in the third quarter."
About FUSILEV(R) (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is also indicated after high-dose methotrexate therapy in osteosarcoma. Additionally, FUSILEV is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com.
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for Spectrum's approved drugs, continuing to build Spectrum's team, leveraging the expertise of partners around the world to assist Spectrum in the execution of its strategy, that we expect to submit the additional data in the third quarter, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that Spectrum's existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that Spectrum's existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum's efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum's lack of significant revenues, limited marketing experience, dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. (R) and Fusilev(R) are registered trademarks of Spectrum, TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
SOURCE: Spectrum Pharmaceuticals
Spectrum PharmaceuticalsPaul ArndtSenior Manager, Investor Relations949-788-6700x216
Copyright Business Wire 2010
Antwort auf Beitrag Nr.: 38.769.753 von future_trader am 20.01.10 07:31:30Ich denke schon. Wenn Zevalin "normal" läuft sollten alle Optionen ausgeübt werden. Kurse bis unter 10 USD halte ich dann für 2010 für möglich - aber erst im HJ2. 2011 mit möglicher Eoquin Fantasie dann auch womöglich Ausbruch über 10USD. Wie gesagt, wenn es "normal" läuft ("normal" definiere ich für mich über die Zevalin-Umsatzschablone für die kommenden Jahre, die ich letztes Jahr als mein Maßstab gepostet habe).
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Antwort auf Beitrag Nr.: 38.747.216 von future_trader am 15.01.10 17:47:46Das ist doch der Knaller. Kaum sind die Optionen weg, dann geht es über 5 Dollar.
Ich bin gespannt, ob die warrants zu 5,11 aus der ersten KE ausgeübt werden.
Gruss future_trader
Ich bin gespannt, ob die warrants zu 5,11 aus der ersten KE ausgeübt werden.
Gruss future_trader
Antwort auf Beitrag Nr.: 38.759.428 von Ville7 am 18.01.10 19:21:12Hey Ville - dir auch ein gutes Neues 
@swifti
was heißt den das
@swifti
was heißt den das
Antwort auf Beitrag Nr.: 38.759.428 von Ville7 am 18.01.10 19:21:12Der Spruch hätte ja tatsächlich von Vajo stammen. Schön aber solches von einem durchaus kritischen Investor wie Ville7 zu hören. Lassen wir das Jahr kommen! 
2010 und 2011 werden höchstwahrscheinlich Spectrum Jahre zum Genießen. Nachträglich noch ein gutes Neues!
Heute ist doch der Verfallstag der vielen Optionen. Könnte vielleicht ab Montag bergauf gehen.
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