Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 07-OCT-2009 12:22 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Response to Clinical IR
Trans-BLA Group: N
Related STNs: None
Related PMCs: None
From: firstname.lastname@example.org [mailto:email@example.com]
Sent: Wednesday, October 07, 2009 12:22 PM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com
Subject: Re: Cervarix - PMC - Submission of Final Clinical Study Report Dates
GSK agrees to commit to submitting the final clinical study reports for the long-term efficacy studies listed in your mail. Please find in the attachment the timings we would propose for the submission of these reports, except for HPV-009. As you know, HPV-009 is under NCI supervision, therefore we are checking with them before committing to timings for this study. We expect to have the details for HPV-009 tomorrow.
If you have any questions on the other studies, please don't hesitate to ask.
Thanks and best regards,