


Correspondence Between Dendreon and CBER - Provenge, February 6, 2010


 
(System Info - 126759 Smith Elizabeth 04/22/2010 18:56:44 TULL)


From: Smith, Liz [lsmith@Dendreon.com]
 Sent: Tuesday, February 06, 2007 9:07 AM
 To: Bross, Peter F (CBER); Liu, Ke; Zhen, Boguang (CBER)
 Cc: Tull Lori

Attachments: t_DP_CSRt33_u9137-014 _t33u.rtf; 9125-072 Query.pdf; FDA
 Response_DP Changes_Final-hk.xls; KM_DP01_20070205 (2).doc; Subject 9125-017
 Query.pdf

Dear Peter, Ke, and Bo:

 Thank you for the call yesterday. As discussed, attached is a spreadsheet that
 identifies each time the p value changed for the primary endpoint (TTP) for 
9901
 with supporting information. Specifically, for each date change, we have
 included:

 -Subject #
 -Treatment assignment
 -Randomization date
 -Original description from the BLA
 -Initial and new progression dates
 -Rationale for the date change
 -References to the supporting documentation

 In most cases, supporting documentation is already contained in CRFs or queries
 in the BLA for each subject. However, for Subjects 9125-017 and 9125-072,
 supporting queries are attached. We are awaiting the supporting documentation
 from --(b)(4)-- for Subject 9137-014 and will send that along when I get it.

 Due to the errors identified (with your help!) in Appendix 16.1.9.10, please
 consider the attached spreadsheet as the definitive information for the
 progression date changes. Also, we recalculated the TTP log rank p value and HR
 after the date change for Subject 9137-014. The new p-value (2 sided, Log Rank)
 is 0.048 and the HR is 1.455. I have attached an updated SAS output reflecting
 this change.

 We are working on your other requests and will get back to you within the next
 week.

 Thanks so much. Please feel free to e-mail or call me.

 Best, Liz

 ********************************************
 Elizabeth C. Smith
 Vice President of Regulatory Affairs
 Dendreon Corporation
 3005 First Ave
 Seattle, WA 98121
 t: 206.829.1556/ f: 206.219.1004/ m. 206.719.4366
 esmith@dendreon.com
 *******************************************



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