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Record of Telephone Conversation, March 5, 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: 05-MAR-2009 12:00 AM Initiated by FDA? Yes
Author: DEBRA CORDARO
FDA Participants: Debbie Cordaro
Non-FDA Participants: --(b)(4)--
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The firm was called on March 5, 2009 seeking clarification of a statement submitted in the January 21, 2009 BLA. Following the pre-BLA meeting to discuss clinical issues, Bioclon provided minutes stating that when the BLA is submitted they intend to respond to disagreements with FDA’s comments for points 1, 3, 5 and 8 from that meeting.
The firm was asked were in the BLA these clarifications can be found.