Submission Type: BLA Submission ID: 125296/0 Office: OVRR
Product: Adenovirus Vaccine Live Oral Type 4 and Type 7
Applicant: Teva Women's Health, Inc.
Telecon Date/Time: 26-Jan-2011 04:08 PM Initiated by FDA? Yes
Communication Category: Information Request
Author: HELEN GEMIGNANI
Telecon Summary: Certificate of Compliance Form 3674
FDA Participants: Helen Gemignani
Non-FDA Participants: Valerie Mulligan
Please review your Certificate of Compliance Form 3674 and review whether it would be appropriate to check choice "C" in #9 and subsequently prudent to list the NCT number for #10.