Omidubicel is formerly known as NiCord. FDA's request came during a pre-BLA meeting, which takes place before a company files its biologics license application (BLA) to officially ask for approval. During that meeting, the agency didn't ask for "additional clinical data to initiate the BLA (Pre-Biologics License Application) submission once analytical comparability is demonstrated," Gamida said in a statement. Gamida now expects to submit the BLA in the first half of 2022 instead of late this year. RELATED: Novartis-backed Gamida hits goal in phase 3 cancer trial Currently, patients with hematological cancers such as leukemia and lymphoma turn to hematopoietic, or bone marrow, stem cell transplantation to restore bone marrow function. However, it can be difficult to source donor-matched cells for all patients, forcing them to use alternatives such as umbilical cord blood.