The FDA's acceptance of Abeona's BLA resubmission for pz-cel represents a significant milestone in RDEB treatment development. The April 29, 2025 PDUFA date sets a clear timeline for potential market entry. The therapy's unique mechanism - providing collagen VII expression through integrated COL7A1 gene copies - addresses a fundamental aspect of RDEB pathology. Supporting data from both Phase 3 VIITAL™ and Phase 1/2a studies, with up to 8 years of follow-up, demonstrates robust long-term safety monitoring. If approved, this first-in-class autologous cell-based gene therapy could transform RDEB treatment. The potential Priority Review Voucher (PRV) represents significant value, as these vouchers have historically sold for $100-200 million, providing additional financial upside beyond the therapy's commercial potential.