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& Pellesi, L
In an ongoing Phase 2a study assessing IDR as lead-in (24 weeks) followed by 12 or 24 weeks of IFN additional IDR doses in HBeAg-negative CHB subjects virally suppressed on nucleos(t)ide analog (NA) therapy (AB-729-201, IM-PROVE I), soluble immune biomarkers were profiled and association with HBsAg response assessed
Manufacturers may petition FDA for inclusion on the Green List, but this requires providing robust evidence of compliance with cGMP standards, including Certificates of Analysis, process validation, and detailed manufacturing records
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