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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, December 22, 2011- 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: 22-December-2011 1:00 PM        Initiated by FDA? Yes
Telephone Number: ------(b)(4)------
Communication Categorie(s):
Outstanding information\BLA timeline
 
Author: RAMANI SISTA
Telecon Summary:
 Outstanding information\BLA timeline
FDA PARTICIPANTS:
Ramani Sista
Stephanie Simek
 
 
NON-FDA PARTICIPANTS:
Sharon Miller
Michael Aubrey
Brian Freed
------(b)(4)------
Sabine Stockinger
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 
 
Telecon Body

FDA stated that after an internal meeting, several disciplines indicated that there are outstanding issues requiring information from the Sponsor to complete their reviews. Since the PDUFA goal date for this application is March 2, the team should have completed their reviews by now. FDA briefly explained the BLA timeline and review process to the Sponsor and indicated that the team could not wait till the end of the cycle to complete their reviews and make a recommendation. There were in built processes that required reviews to be completed several weeks ahead of the goal date. Unfortunately, in this case the team was still waiting for data. Despite repeated requests, the Sponsor has failed to submit or submitted information in power point slides which is unacceptable. FDA strongly recommended the Sponsor submit all the outstanding information as soon as possible. The Sponsor agreed to work with FDA team to submit information in a timely manner.