
Record of Telephone Conversation, October 5, 2012 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 05-Oct-2012 01:05 PM        Initiated by FDA? Yes

Telephone Number: Communicated via e-mail

Communication Categorie(s):

1. Information Request

Author: TIMOTHY FRITZ

Telecon Summary:

Confidence intervals for Amendment 63 data (clinical subanalyses)

FDA Participants: Timothy Fritz

Non-FDA Participants: Penny Post

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From:                    Fritz, Timothy

Sent:                      Friday, October 05, 2012 1:05 PM

To:                         'Penny Post'

Subject:                 CBER Information Request STN 125285

 

Importance:           High

Dear Dr. Post-

 

We have received your September 28, 2012, response (STN 125285, Amendment 63) to CBER’s September 9, 2012 Information Request regarding gender, racial and ethnic sub-group analyses and have the following additional request:

 

1. Please revise Tables 1, 2, 3, 4, 5, 7, and 8 to include 95% confidence intervals for each point estimate.

 

Please submit your response as an amendment to STN 125285. If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.

 

Thank you.

Timothy A. Fritz, Ph.D. 
Microbiologist 
FDA/CBER/OVRR/DVRPA/CMC2 
WOC2 HFM-478
1451 Rockville Pike 
Rockville, MD 20852 
Phone: 301-796-2640 
Fax: 301-827-1597

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