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Second Provenge FDA panel review "unlikely"
23 November 2009
Nancy Faigen
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23 November 2009
Nancy Faigen
nancy.faigen@informausa.com
The US FDA has accepted for review Dendreon's amended BLA for Provenge (sipuleucel-T), setting a user fee deadline of May 1st, 2010.
Dendreon said that the agency considered the package that will now be reviewed a complete Class II resubmission, following an action letter received by the...
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