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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memorandum - Provenge, January 8, 2007

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

MEMORANDUM

Date: January 8, 2007

To: BLA Committee

From: Bhanu Kannan, HFM-664
OCBQ/Bioresearch Monitoring Branch

Subject: STN 125197/0 Filing Action

I have reviewed the Clinical and Statistical (case report tabulations) section(s) of Dendreon’s BLA (STN Number 125197/0) and find the application acceptable for filing.

/s/
_____________________
Bhanu Kannan