US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 761377 (Jun 27, 2024)
Issued June 27, 2024
Issued
June 27, 2024
Application
BLA • 761377
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due June 27, 2025Requires resubmission addressing deficiencies.
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