Vaccines, Blood & Biologics
Record of Telephone Conversation, March 2, 2009 - Anascorp
Submission Type: Original Application Submission ID: 125335/0 Office: OBRR
Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)
Instituto Bioclon, S.A. de C.V.
Telecon Date/Time: 04-MAR-2009 12:00 AM Initiated by FDA? Yes
Author: DEBRA CORDARO
Excel spreadsheets requested
FDA Participants: Debbie Cordaro
Non-FDA Participants: ------------(b)(4)-------
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
On Feb 6, 2009, the firm was sent an IR asking for an Excel spreadsheet of the PK data. Amendment 5 included a hardcopy of the spreadsheet but not the Excel spreadsheet itself. The firm was asked to send in the spreadsheet.