
Record of Telephone Conversation, August 10, 2012 - Flucelvax


 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR

 

Product:

Influenza Vaccine (MDCK Cells)

 

Applicant:

Novartis Vaccines and Diagnostics, Inc.

 

Telecon Date/Time: 10-Aug-2012 10:00 AM        Initiated by FDA? Yes

 

Telephone Number: 617-871-8325

 

Communication Categorie(s):

1. Information Request

 

Author: TIMOTHY NELLE

 

Telecon Summary:

Request for non-inferiority study statement for 6m - 4yos

 

FDA Participants: TIMOTHY NELLE

Non-FDA Participants: Matt Gollwitzer

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

 

Telecon Body:

Novartis was informed that OVRR management has expressed great concerns about modifying V58P16 for the purposes of demonstrating of non-inferiority in children 6 months to less than 4 years old. As such, DVRPA requests a simple paragraph describing a separate clinical study to demonstrating non-inferiority. This paragraph only needs to identify the ages of the subjects, the sample sizes of the study groups, and the approximate dates for protocol submission, study start, and FSR.

 

DVRPA understands that this statement will only reflect a preliminary clinical plan that Novartis may choose modify during the review of this BLA.

 

DVRPA requested a response no later than early Monday morning. Novartis was also informed that if their management would like to discuss this situation with OVRR management, they should contact Dr. Theresa Finn.