System Info - 107199 MCWATTERS, BERNARD 07-Oct-2009 15:08:21 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 30-JUL-2008 12:00 AM
Initiated by FDA? Yes
Author: BERNARD MCWATTERS
Requested programs used by Novartis to analize raw data so the CBER statistical reviewer can repeat the analysis. Novartis agreed to submit these programs in pre-BLA discussions.
FDA Participants: Bernard J.P. McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
I got your message that you called a couple of days ago. As of now, the review of your BLA is ongoing. We are currently in the process of deciding if the BLA can be filed and if it can, if there are any deficiencies. The filing deadline is 60 days after we received the BLA. We will let you know at that point if the BLA will be filed. I am still expecting you to send in the programs that the statistical reviewer on the team can use to analyze your data sets. I remember that you told me that this will happen within a month of submission. Make sure that these programs are submitted in a timely manner. Thanks.
Bernard J.P. McWatters, Ph.D.
1401 Rockville Pike rm. 389N
Rockville, MD 20852
Office - 301-827-5379