Post by stcks on Mar 21, 2023 9:15:02 GMT
Does anyone in or have thoughts on Gamida Cell? They are in cell therapy for patients with blood cancers and solid tumors. NAM to cell sources, including umbilical cord blood-derived cells and natural killer (NK) cells, to create allogeneic cell therapy candidates.
High risk with High rewards
PDUFA May 1 for Omidubicel with the indication of Hematologic malignancies (blood cancers). It is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU. Demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multicenter, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic
Novartis owns 5%,
Problems - limited Cash, Israeli Biotech, Manufacturing CLR (last year) but things look good for May
ashpublications.org/blood/article/138/16/1429/476235/Omidubicel-vs-standard-myeloablative-umbilical
High risk with High rewards
PDUFA May 1 for Omidubicel with the indication of Hematologic malignancies (blood cancers). It is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU. Demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multicenter, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic
Novartis owns 5%,
Problems - limited Cash, Israeli Biotech, Manufacturing CLR (last year) but things look good for May
ashpublications.org/blood/article/138/16/1429/476235/Omidubicel-vs-standard-myeloablative-umbilical