
 

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
 
   