PD : J&J actualiza el ensayo OVA 301 y tal y como ya sabiamos consta que el Dossier se elaboro con los Resultdos existentes en fecha Mayo 2008 ... con esos datos el ODAC y la FDA saben que Yondelis Funciona y que alarga la vida a las pacientes ... pero quieren mas datos Finales ... y es ahi en donde estan todas las dudas ... ¿ Sera capaz J&J de Convencer o de tener esos datos que pide la ODAC para antes de la evaluacion de la FDA en Septiembre ? ... de ser asi Bingo ... de No ser asi la FDA nos va a pedir esos datos y meses de por medio ...
Primary Outcome Measures:
*.- Progression-free survival as assessed by independent radiology review [ Time Frame: every 8 weeks after randomization ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
*.- Overall survival [ Time Frame: every 8 weeks for first 2 years then every 3 months thereafter ] [ Designated as safety issue: Yes ]
*.- Response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
*.- Safety [ Time Frame: weekly until treatment is terminated ] [ Designated as safety issue: Yes ]
*.- Pharmacokinetics [ Time Frame: weekly during cycle 1 & 2 ] [ Designated as safety issue: No ]
Study Start Date: April 2005
Estimated Study Completion Date: May 2011
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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