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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, February 2, 2012 - HPC Cord Blood

 

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA    Submission ID: 125391/0    Office: OCTGT
Product:
Hematopoietic Progenitor Cells,Cord (HPC-C)
Applicant:
Clinimmune Labs
Telecon Date/Time: 02-February-2012 3:00 PM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)------
Communication Categorie(s):
Major amendment
 
Author: RAMANI SISTA
Telecon Summary:
Major amendment
FDA PARTICIPANTS:
Ramani Sista
Yong Fan
Kim Benton
Stephanie Simek
Joydeep Ghosh
 
NON-FDA PARTICIPANTS:
Sharon Miller
Brian Freed
 
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 
Telecon Body
Following introductions, FDA stated that they had received amendment 4 from ClinImmune. Since this amendment was received within the last few weeks of the goal date and the volume of information was substantial, the division would consider this to be a major amendment, which will extend the clock by three months. This is a one time extension, with the new goal date being June 2, 2012. The Sponsor was also informed that they will receive a letter acknowledging the major amendment shortly.
 
FDA sterility team asked the Sponsor if any new sterility information was included in the amendment. The Sponsor stated that their sterility studies were ongoing and they have not submitted the information yet.