Record of Telephone Conversation, July 17, 2014 - TRUMENBA

Submission Type: BLA Submission ID: 125549/0 Office: OVRR

Product:
Meningococcal Group B Vaccine

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 17-Jul-2014 02:30 PM Initiated by FDA? Yes

Telephone Number: 866-453-8391

Communication Categorie(s):
1. Information Request
2. Other - Request to contact E -DMC chair

Author: MICHAEL SMITH
Telecon Summary:
Request to contact E-DMC chair

FDA Participants: 
Lucia Lee, Drusilla Burns, Amelia (Dale) Horne, Liz Sutkowski, Ted Garnett and Mike
Smith

Non-FDA Participants: 
Emilio Emini, Kathrin Jansen, Donna Boyce, Bill Gruber, Joe Eiden, John Perez, Laura
York, Mickey Lorenzen, Luis Jodar, Scott Patterson, Judy Absalon, John Mays and
Carmel Devlin.

Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:

CBER and Pfizer discussed the possibility of CBER directly contacting the External
Data Monitoring Committee (E-DMC). Pfizer agreed that it would be acceptable for CBER to contact the chair of the E-DMA. CBER and Pfizer discussed procedures to follow if such a contact were to be made.
