CEL-SCI Advances Multikine Commercialization Efforts
"During the fiscal second quarter, we made significant progress advancing Multikine toward potential commercialization and regulatory approval in multiple markets," stated CEL-SCI CEO Geert Kersten. "Our strategic partnership with Amarox represents an important milestone for CEL-SCI, providing a pathway to potential early commercialization and revenue generation for Multikine in Saudi Arabia through the SFDA's Breakthrough Medicine Designation process as well as potential market access in the GCC countries. At the same time, we are starting efforts to initiate patient enrollment in our pivotal U.S. FDA Confirmatory Registration Study later this summer/fall. We believe the study's design, which allows for rapid assessment of pre-surgical tumor response following a short course of Multikine treatment, may provide an opportunity to pursue accelerated approval in the U.S. With strengthening financial support, continued management investment in the Company, and increasing international interest in Multikine, we believe CEL-SCI is entering an inflection point."