RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 01-JUL-2009 03:09 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Response from Sponsor regarding Information Request for Statistical Information
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: email@example.com [mailto:firstname.lastname@example.org]
Sent: Wednesday, July 01, 2009 3:09 PM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com
Subject: Re: Cervarix BLA - Request for Statistical Information
We have now discussed this request with NCI and they are preparing the information requested, which will be submitted to the BLA shortly (by July 10-13).
They have informed us that there is no clinical report for the analysis but that the manuscript they have prepared for publication includes in full detail the methods and analysis. The manuscript is currently under review by the British Medical Journal but I have attached the manuscript to this mail, prior to submitting it to the BLA, so that the review team can start their review.
The submission to the BLA will include the following items:
Memo written by Sholom Wacholder to accompany data and manuscript
Manuscript submitted to BMJ
Tables and figures for the manuscript submitted to BMJ
Format library for the SAS transport file.
SAS dataset used for the analysis, in SAS transport format.
Presentation by Sholom Wacholder to IDMC responsible for oversight of study HPV-008
Minutes of the IDMC meeting at which analysis was presented
Safety statement issued by the IDMC
We hope that this information will answer your request.
Thanks and best regards,
"Gemignani, Helen S" <Helen.Gemignani@fda.hhs.gov>
cc Cynthia.A.D'Ambrosio@gsk.com, email@example.com
Subject Cervarix BLA - Request for Statistical Information
Please refer to your March 27, 2009 submission to the BLA. A summary report of the NCI analysis of spontaneous abortions in the peri-vaccination period was included in the Supplement to the Cumulative Safety Update of the BLA on pp. 128-131. CBER requests that you submit the full analysis report and methodology used to demonstrate that the difference noted between treatment groups was not statistically significant. Please submit data used to conduct this analysis.
You also indicate that the data regarding spontaneous abortions were presented to the IDMC for study HPV-008. CBER requests meeting reports from the IDMC meeting(s) at which this issue was discussed.
Please submit your response as an amendment to the BLA.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
56 Pages found to be non-releasable: (b)(4)