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Re: None

Tuesday, 09/08/2020 11:44:31 AM

Tuesday, September 08, 2020 11:44:31 AM

Post# of 963
Q- to IR:

Do you know if GMDA is entitled to PRV -Priority Review Voucher? its worth $100-250M ?

A-

Because omidubicel has Breakthrough Therapy Designation and based on the strength of the Phase 3 data, we anticipate a priority review.

Just please stress that this is our hope and expectation based on what we know to date (Breakthrough Designation, strong topline data) – but that it is not a guarantee and the FDA will make its own assessment once the BLA is submitted.