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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon - Provenge, May 9. 2007

Telecon
May 9, 2007

Participants
FDA: Keith Wonnacott
Dendreon: Elizabeth Smith

Summary:
Ms. Smith called to inform me that Dendreon is interested in setting up a meeting to discuss how to resolve the CMC deficiencies that were identified in the complete response letter. She said that they plan on finishing their enrollment in the ongoing study later this year and would like to collect as much data as possible from that study to address our concerns as possible. I informed her that we would be happy to discuss with her the best way to address the deficiencies and assess how data from the ongoing study could be used. Ms. Smith also asked if there was any reason these deficiencies were not communicated during the review of the BLA. I informed her that we were not prepared to discuss them until late in the review cycle and so it was decided to include them in the CR letter rather than try to resolve them. However, I said that I thought the approach might have been different if the CMC deficiencies were the sole basis for the CR letter. She asked if there were any concerns with how Dendreon interacted with the FDA during this review cycle. I informed her that I felt there were very positive interactions between the FDA and Dendreon. Finally, she asked the basis for our review decisions and I informed her that I thought the review team did an excellent job of focusing on the science and the regulations to make their decisions.