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makabuziness

07/07/07 3:06 PM

#4485 RE: p3analyze #4480

No argument here, just posted what management was saying at the ASM. You and they agree on at least one thing per your last sentence. That is, we now have plenty of time to fix the CMC issues.
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rancherho

07/07/07 4:07 PM

#4488 RE: p3analyze #4480

>>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.