CEL-SCI Corporation announced on May 21, 2025, that it completed its Breakthrough Medicine Designation application for Multikine for submission to the Saudi Food and Drug Authority (SFDA) in Saudi Arabia. Multikine is an immunotherapy administered before surgery for newly diagnosed previously untreated head and neck cancer.
The Breakthrough Designation Application is expected to be formally submitted to the SFDA within the next few weeks by the company’s prospective Saudi partner. According to the SFDA, the response time to such an application is approximately 60 days.
Under the SFDA’s new Breakthrough Medicine Designation program, Multikine would immediately become available for patient access and reimbursement upon it being granted the designation. This initiative aligns with Saudi Arabia’s Vision 2030 to become a global biotech hub.
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