Record of Telephone Conversation, September 29, 2011 - Ducord
Submission Type: BLA Submission ID: 125407/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Duke University School of Medicine
Telecon Date/Time: 29-Sep-2011 10:00 AM Initiated by FDA? Yes
1. Information Request
Author: DONNA PRZEPIORKA
Telecon Summary: Requested revised dataset.
FDA Participants: YY Zhu, D Przepiorka
Non-FDA Participants: J Kurtzberg, --(b)(4)(b)(6)--, B Burnette, R Parrish
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Requested revised dataset with missing variables. Discussed what data is actually available. List of variables requested was emailed to the applicant.