Development DelaysAn RTF can be addressed, but it does extend timelines for ANKTIVA in the papillary NMIBC setting.
Regulatory ChallengesImmunityBio recently disclosed an unexpected Refusal to File (RTF) letter from the FDA regarding its supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive NMIBC patients with papillary-only disease.
Regulatory UncertaintyThe RTF letter introduces regulatory uncertainty, despite the identical treatment protocol between CIS and papillary cohorts.