CBER remains on track for multiple April PDUFA decisions, with Replimune’s oncolytic virus Vusolimogen oderparepvec among the scheduled calls. The excerpt also notes that an Orca Biosystems Treg cell therapy decision (Orca-T) was delayed by ORCA to July 6 after CMC updates were provided. For sponsors, the practical signal is that manufacturing data packages and CMC responsiveness are still gating timelines, even when programs are otherwise ready for review. Multiple PDUFA readouts in quick succession can rapidly reshape expectations for the oncolytic virus and T cell therapy tracks. The development underscores how near-term FDA calendar movement is being driven by CBER’s internal scheduling and by the agencies’ requests for updated manufacturing documentation.