Omidubicel currently has an FDA Breakthrough Designation which is "process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint"
Basically, this means that Omidubicel has so much potential, that the FDA wants to accelerate the approval process.
Basically, this means that Omidubicel has so much potential, that the FDA wants to accelerate the approval process.