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5.94 -2.85 (-32.42%) http://www.google.com/finance?q=NASDAQ:GENT Gentium S.p.A. Withdraws New Drug Application for Defibrotide Gentium S.p.A. announced that it has voluntarily withdrawn the New Drug Application (NDA) for Defibrotide following recent correspondence from the United States Food and Drug Administration (FDA) identifying numerous 'Refuse to File' issues regarding the Company's NDA submission. In their initial review, the FDA raised concerns regarding the completeness of the datasets for both the treatment and prevention studies. The FDA requested that the Company conduct additional quality reviews of the original datasets and databases. The FDA also requested additional details regarding the conduct and monitoring of the trials by the independent review committee. http://www.reuters.com/finance/stocks/GENT.O/key-development… Chance für nen Einstieg? |
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| aus der Diskussion: | Gentium: Defibrotide - Orphan Drug mit Blockbusterpotential |
| Autor (Datum des Eintrages): | Aurum2010 (18.08.11 20:20:47) |
| Beitrag: | 51 von 51 (ID:41971837) |
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