


Telecon With Dendreon - Provenge, April 16, 2010

 
(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. 
 
