Record of Telephone Conversation - Cervarix, October 24, 2008
System Info - 94739 SHONE, DEANNA 20-May-2009 17:28:49 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed
Telecon Date/Time: 24-OCT-2008 12:00 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
CBER Statistical comments in response to GSK's 29-Sep-2008 HPV-008 RAP submission to the BLA.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Sent: Friday, October 24, 2008 1:34 PM
Subject: Comments on 9/29/08 BLA Submission
Following are some statistical comments RE: September 29, 2008, HPV-008 RAP submission to the BLA. Please let me know if you have any questions or need additional clarification.
1) There are more than 30 exploratory objectives to be evaluated in the Reporting and Analysis Plan for efficacy for HPV-008. In these analyses, Type I errors are not adjusted for multiple comparisons. Please acknowledge that results based on these analyses cannot be used to support post-licensure supplements for labeling changes.
2) Please refer to page 38, section 4.5.3. Given that the number of breakthrough cases will not be large, too many covariates presented in the Cox regression models may cause over-adjustment. In addition, collinearity between covariates may emerge. Please comment.
3) Please note some minor editing changes to be made on page 13: Please add “HRW (=High-risk (oncogenic) HPV types without HPV-16 or HPV-18: HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)” in the fourth paragraph
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
phone: (301) 827-3070
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