Gamida Cell Ltd (GMDAQ)

[midastouch017]

Gamida Cell Ltd. (NASDAQ: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, recently announced that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA) yesterday, the company plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell's wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.

https://www.prnewswire.com/news-releases/gastrointestinal-cancer-treatment-trials-driven-by-rising-incidences-of-colorectal-cancer-301464414.html