Die Kommission scheint sich übrigens sehr uneins gewesen zu sein, was die Zulasung von Ranexa betrifft ... 5 von 11 Mitgliedern waren für die Markteinführung, 6 dagegen ... also eine ganz schön enge Geschichte!! The analyst noted that five of the 11 members of the FDA panel had voted to approve the drug outright, 5 of 11= 45.45%, while the other six asked for additional data. Of those wanting more information on the drug, some said the Ranexa was "close to approval," Mr. Wei said. "We appreciate the thorough review by the advisory committee of Ranexa and we look forward to meeting with the FDA as soon as possible to discuss next steps," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. |
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aus der Diskussion: | +++ CV Therapeutics Inc (CVTX) - Kurssturz +++ |
Autor (Datum des Eintrages): | seinfeld (11.12.03 09:37:48) |
Beitrag: | 96 von 470 (ID:11573944) |
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