Suggest people have a read of this and digest it......
https://pink.citeline.com/PS147548/US-FDAs-Use-Of-CRLs-Hit-A-High-Note-In-2022-One-Third-Of-Novel-Agent-Decisions-Were-Not-Approvals
The 2022 CRLs for novel agents were almost split between letters citing clinical concerns and letters citing quality issues (11 CRLs focused on clinical topics, 8 focused on quality and one is undisclosed). However, the road ahead appears rockier for the clinical cohort than the quality CRLs.
Where will we be in 12 months time?, page-87
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