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GPC Biotech's Zulassungsantrag für Satraplatin wird am 24. Juli 2007 von ODAC-Ausschuss diskutiert

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Die GPC Biotech AG (Frankfurt: GPC; TecDAX 30; NASDAQ: GPCB) gab heute bekannt, dass das Unternehmen von der US-Zulassungsbehörde FDA informiert wurde, dass der Zulassungsantrag für Satraplatin zur Zweitlinien-Chemotherapie von Patienten mit hormonresistentem Prostatakrebs am 24. Juli 2007 vom "Oncologic Drugs Advisory Committee" (ODAC) diskutiert wird. Bei Medikamentenzulassungen und anderen durch die FDA geregelten Bereichen, sprechen solche externen Experten-Ausschüsse der FDA unabhängige Empfehlungen aus. Obgleich die Beratungsausschüsse Empfehlungen aussprechen, werden abschließende Entscheidungen von der FDA getroffen. Kürzlich hatte die FDA den Zulassungsantrag für Satraplatin zur Prüfung angenommen und dem Zulassungsantrag den sogenannten "Priority-Review"-Status erteilt. Eine FDA-Entscheidung bezüglich des Zulassungsantrags wird
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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.