US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 125745 (Jan 15, 2025)
Issued January 15, 2025
Issued
January 15, 2025
Application
BLA • 125745
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due January 15, 2026Requires resubmission addressing deficiencies.
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