Record of Telephone Conversation, December 12, 2011 - MenHibrix
Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 12-Dec-2011 02:35 PM Initiated by FDA? Yes
Telephone Number: email@example.com, firstname.lastname@example.org, email@example.com
1. Information Request
Author: KIRK PRUTZMAN
Request for data for Serology response Figures 5 and 6 and Tables 6-8.
FDA Participants: KIRK PRUTZMAN, DAVID STATEN, JOSEPH TEMENAK
Non-FDA Participants: JODY GOULD, NORRIS PYLE, ELISA HARKINS
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
We have been reviewing your responses to our Complete Response Letter dated September 21, 2011, and have the following information request.
1. Regarding your responses to our serology questions (CR Letter Items 1, 2, and 3), please submit the data used to generate Figures 5 and 6 and the data used to calculate tables 6, 7, and 8 as data files.
Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
1451 Rockville Pike (WOC2)
Rockville, MD 20857
Phone: (301) 796-2640