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Vaccines, Blood & Biologics

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Telecon with Dendreon - Provenge, November 12, 2007

(System Info - 126196 Finn Thomas 04/16/2010 12:41:06 TULL)
STN:  BL 125197/0

10/12/07  1:45 PM  telecon with Dendreon.  206-412-0043

Dendreon Participants: Connie Spooner
FDA participants: Tom Finn

Connie Spooner from Dendreon called back in response to my voicemail the night before.  She thanked me for the information provided and said they would be sure to have Mike Poor from Scheduling and someone from QC to be present to talk about shipping and logistics issues.

She also said that they would have someone available to talk about current manufacturing scale plans, though she didn’t know what those plans were.  She wondered whether we would be covering process validation.  I responded that we would likely be covering that topic and that representatives from DMPQ would be present.  She stated that they now have a lot more manufacturing experience at the New Jersey facility and that they could discuss that data.

She asked if we would be sending out our response to the briefing document in advance of the meeting.  I responded that we would try and send comments out before hand, but that they probably wouldn’t be ready until Monday.