magolibero
..se la sà gira..
Voilà ce que NicOx cherche à faire :
Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave®
Interim Results from Outcomes Trial Would Support Resubmission of Contrave NDA
SAN DIEGO, Sept. 20, 2011 /PRNewswire via COMTEX/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that following a recent meeting with senior officials in FDA's Office of New Drugs (OND), the Company received written correspondence detailing OND's design requirements for a cardiovascular outcomes trial (CVOT) for Contrave® that would address the Complete Response Letter (CRL) received in January 2011. Orexigen believes that these design requirements are reasonable and feasible and provide the certainty required to reinitiate development of Contrave. Importantly, FDA stated that "if the interim analysis meets the specified criteria to exclude an unacceptable increased cardiovascular (CV) risk, the drug could be approved." Furthermore, FDA stated that "While we still plan to convene a public advisory committee meeting to discuss topics related to obesity drug development early next year, that meeting will not impact on the advice provided in this letter and the agency will honor the advice provided."
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anche questi di ARNA vogliono rimettersi in gioco
New Data Analyses from Lorcaserin Phase 3 Clinical... -- SAN DIEGO and WOODCLIFF LAKE, N.J., Sept. 26, 2011 /PRNewswire/ --
Nuove analisi dei dati da Lorcaserin studi clinici di fase 3 che sarà presentato alla Obesità 2011
SAN DIEGO e Woodcliff Lake, New Jersey , settembre 26, 2011 / PRNewswire / - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) e Eisai Inc. ha annunciato oggi che le nuove analisi dei dati dalla fase 3 Lorcaserin programma di sperimentazione clinica saranno presentati in sessioni poster a obesità 2011, la 29a Annual Scientific Riunione della Società obesità in Orlando, Florida . I manifesti evidenziati sotto verranno visualizzati nella sala da ballo Cypress del World Center Marriott il 3 Ott 2011 , dalle 9:30-01:45 orario della costa orientale (ET) e dalle 15:15-6:30 ET . Gli autori saranno disponibili presso i manifesti su 3 OTT 2011 , dalle 12:30-1:30 ET .
dopo il KO di ottobre dell'anno scorso
FDA Issues Complete Response Letter for Lorcaserin New... -- SAN DIEGO and WOODCLIFF LAKE, N.J., Oct. 23, 2010 /PRNewswire-FirstCall/ --