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Telecon - Provenge, April 14, 2010
(System Info - 126650 Benton Kimberly 04/22/2010 08:04:00 TULL)
April 14, 2010, 3:30 p.m.
Dendreon participants: Helen Kim, Karen Krstulich
FDA participants: Keith Wonnacott, Thomas Finn, Kimberly Benton
FDA initiated this telecon to request that Dendreon prepare a proposal for CMC information to be submitted post licensure. The discussion involved the types of data FDA wishes to receive, including summaries, in tabular or graphical form, of lot release testing data for all lots of sipuleucel-T; lots that do not complete manufacturing and the reason, the number of aphereses required performed per patient and the reason when more than 3; data trending; and actions taken as a result of observed trends.
It was agreed that submission of this information on a yearly basis was an acceptable period, and for convenience this could be included in the BLA Annual Report. It was agreed that this would be documented as a Post Marketing Commitment if an approval letter were to be issued.
Dendreon agreed to discuss this request internally and follow with statement of commitment submitted as an amendment to the BLA.