US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 761266 (Jan 3, 2025)
Issued January 3, 2025
Issued
January 3, 2025
Application
BLA • 761266
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due April 3, 2025Requires resubmission addressing deficiencies.
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