Dendreon Corp fka DNDNQ

[rancherho]

>>Since the filing would not begin until 2006, let's wait till the last minute to get the jersey plant up and running - because Gold etal thought CMC would not be a problem.<<

Actually, I asked Gold just prior to the start of the 2005 ASM whether DNDN was waiting for the results of 9902a before starting work on a production facility. Gold told me that a production facility was not required to file a BLA, only a production plan. That, of course, was incorrect. A production facility has to be in place and ready for an FDA inspection for a BLA to be considered complete.