
 


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

Liz:

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.

Thanks,
 -Peter
 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
 Peter.Bross@fda.hhs.gov


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


Liz,

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.

-(b)(6)-
 -(b)(6)-
 -(b)(6)-
 -(b)(6)-
 -(b)(6)-

Thanks,

Ke
