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Vaccines, Blood & Biologics
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 29-Aug-2012 09:16 PM Initiated by FDA? Yes
1. Information Request
Author: TIMOTHY NELLE
Narratives for the three deaths that occurred during V58P4
FDA Participants: None
Non-FDA Participants: Matthew Gollwitz
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Via secure email, CBER requested narratives for the three deaths that occurred during clinical study V58P4.