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Record of Telephone Conversation, November 20, 2012 - Q-Pan
Submission Type: BLA Submission ID: 125419/0 Office: OVRR
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
ID Biomedical Corporation of Quebec
Telecon Date/Time: 20-Nov-2012 04:13 AM Initiated by FDA? Yes
Telephone Number: firstname.lastname@example.org; email@example.com, Jillian.M.firstname.lastname@example.org
1. Information Request
Author: KIRK PRUTZMAN
IR regarding Amendment 16 submitted on November 15, 2012
FDA Participants: KIRK PRUTZMAN, CARMEN COLLAZO, JEREMY WALLY
Non-FDA Participants: MICHAEL SCHWARTZ, ROBERT BROBST, JILLIAN HORVATH
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Prutzman, Kirk C
Sent: Tuesday, November 20, 2012 4:13 PM
To: Prutzman, Kirk C; 'Michael Schwartz'; 'Robert Brobst'; 'Jillian Horvath'
Cc: Collazo, Carmen; Wally, Jeremy
Subject: STN 125419 - Qpan IR regarding Amendment 16
Dear Drs. Schwartz, Brobst, and Horvath,
We have the following additional Information Request (IR) regarding Amendment 16 submitted on November 15, 2012 (125419/16).
- Please clarify whether the age cohort in Tables 3, 10, 17, 24, 31 and 38 in Analysis_E1_08 should be "75 years of age or older" (per the submission) or "65 years of age or older".
Please submit your responses in an amendment to the BLA submission. If you have any questions about this communication, please contact Kirk Prutzman, Carmen M. Collazo, or Jeremy Wally.
Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
1451 Rockville Pike (WOC2)
Rockville, MD 20857
Phone: (301) 796-2640