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Vaccines, Blood & Biologics

Imaging Data Request - Provenge, January 31, 2007

(System Info - 126750 Lavoie Deborah 04/22/2010 18:31:43 TULL)

From: Bross, Peter F (CBER)
Sent: Wednesday, January 31, 2007 7:03 PM
To: Liu, Ke; 'Smith, Liz'
Cc: Tull Lori
Subject: Imaging data request


I also discussed this with Dr Batra, he did not think our request for the
imaging review was justified in terms of the total scope of the BLA clinical
review. Unless you propose that the TTP analysis will provide the major support
for the the OS finding it probably will not be worth the trouble to come here to
review these images, although we are certainly willing to do so.

We are obviously unable to conduct a blinded re-adjudication of all the imaging
material and we would probably have to consider any further re-analysis to be
'exploratory.' We are therefore hoping that you can provide additional
information in support of your re-adjudicated analysis through means of an
electronic submission to the BLA, if possible including selected annotated
images which support your changes to the progression dates, without your having
to travel.

Ke or I can discuss with you at your convenience in the next week or two if you
would like clarification.

Peter F. Bross, MD
Medical Review Officer
Office of Cellular, Tissue, and Gene Therapy, HFM-755
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852
Phone 301 827 5378
Fax 301 827 9796

From: Liu, Ke
Sent: Wednesday, January 31, 2007 5:47 PM
To: 'Smith, Liz'
Cc: Bross, Peter F (CBER); Zhen, Boguang (CBER); Tull Lori; Batra, Ashok
Subject: Imaging data for the following subjects. No need to come in person to
show the images


Peter and I talked about the images further. We do not think that you need to
come to show the images in person. Making a trip to come here certainly takes
a lot of your time, resources and preparations. Since the images are
digitalized, you can just send them in.

Please contact Lori for the means to have the images here after your AC prep.

Here are the subjects for whom we would like to have images.




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