(System Info - 126194 Finn Thomas 04/16/2010 12:35:32 TULL)
STN: BL 125197/0
10/11/07 7:10 PM telecon with Dendreon.
FDA participants: Tom Finn
I called Connie Spooner from Dendreon in response to a voicemail she left me on 10/3/07. Ms. Spooner wanted to know whether we required any additional information that was not in the briefing document that we needed for the upcoming meeting to discuss manufacturing issues. She also wanted to know if the responses they gave to the deficiencies were on the right track or if they have misinterpreted the questions.
She was not available at the time, but I left a short voicemail stating that we did not require any additional information at this time. I suggested that they plan on starting out the meeting by clarifying their plans for manufacturing clinical versus commercial product at the New Jersey facility. I also asked that they let us know their current plans for manufacturing scale. During a June, 2007 telecon they had mentioned that they may request a license for full capacity ((b)(4) lots/month) instead of the more limited role out of product as was previously planned.
I also mentioned that it would be helpful if they had someone from QC and the Scheduling group on hand for the discussion so that we could talk about logistics. The kind of estimated shipping data that they supplied was very helpful, but that we may need some additional logistical information.