Pierre Fabre and Atara Biotherapeutics moved to restart the FDA review process for Ebvallo (tabelecleucel), a cell therapy rejected twice before. The companies resubmitted a U.S. application with updated data intended to address the FDA’s prior concerns, with analysts expecting a potential Class 2 BLA resubmission path. The regulatory back-and-forth centers on clinical evidence interpretability and trial design, while the companies said manufacturing and GMP compliance issues were resolved and that the agency’s updated stance is inconsistent with prior alignment. If the resubmission clears, Ebvallo could become a treatment option for EBV+ post-transplant lymphoproliferative disease. For biotech operators, the case is another illustration of how “single-arm, pivotal” frameworks can face execution and interpretability challenges when regulators revisit trial conduct and analysis assumptions.