System Info - 104575 SHONE, DEANNA 09-Sep-2009 16:09:33 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125300/0 Office: OVRR
Meningococcal ACWY Conjugate Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 09-SEP-2009 03:42 PM Initiated by FDA? Yes
Author: CARA FIORE
Request for Men A Standard
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fiore, Cara
Sent: Wednesday, September 09, 2009 3:42 PM
Cc: Valenti, Elizabeth
Subject: Men A standard
We still have not received the MenA polysaccharide internal standard for our in-support testing. (This should come in as a reagent.) Please let us know we should expect this.