Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

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

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

From: Smith, Liz []
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

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

-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, 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

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


This email message including any attachments is for the sole use of the intended
recipient(s) and may contain confidential and privileged information. Any
unauthorized review, use, disclosure or distribution is prohibited. If you are
not the intended recipient, please contact the sender by reply email and destroy
all copies of the original message. If you are the intended recipient, please be
advised that the content of this message is subject to access, review and
disclosure by the sender's Email System Administrator.

Page Last Updated: 05/28/2010
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English