Replies to post #4488 on Dendreon Corp fka DNDNQ

[lumpy9200]

>>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.<<

rancherho's response:
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.

First, for Gold to not know that the production plant needed to be completed and ready for inspection before BLA filing seems to border on incompetence, IMO.

Second, if Gold delayed the NJ facility because he thought CMC would not be a problem again speaks of incompetence. It has been made clear on this board that many new facilities receive 483's, which usually can be corrected and the company moves on. If he truly waited on the facility, which then meant that a 483 would lead to a material delay for Provenge, this alone should be grounds for dismissal..again JMHO.

I believe Gold made his case for being unqualified (not a real word, I know) to run Dendreon, even before he sold shares using information not made public to the shareholders.

Disclosure: I was long DNDN since 2005, bought more at $16 per share, and eventually sold all at prices between $7.51 and $10.42 if my memory serves. I am not part of any lawsuit.

Best regards,
Geoff