Record of Telephone Conversation, October 5, 2012 - Flublok
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 05-Oct-2012 01:05 PM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
1. Information Request
Author: TIMOTHY FRITZ
Confidence intervals for Amendment 63 data (clinical subanalyses)
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, October 05, 2012 1:05 PM
To: 'Penny Post'
Subject: CBER Information Request STN 125285
Dear Dr. Post-
We have received your September 28, 2012, response (STN 125285, Amendment 63) to CBER’s September 9, 2012 Information Request regarding gender, racial and ethnic sub-group analyses and have the following additional request:
1. Please revise Tables 1, 2, 3, 4, 5, 7, and 8 to include 95% confidence intervals for each point estimate.
Please submit your response as an amendment to STN 125285. If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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