US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 761212 (Nov 14, 2024)
Issued November 14, 2024
Issued
November 14, 2024
Application
BLA • 761212
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due November 14, 2025Requires resubmission addressing deficiencies.
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