Challenges For Small BiotechFor small or cash-limited biotech companies, addressing an RTF can be especially challenging if major development work is needed.
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.