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In a statement to NPR, a spokesperson for the Department of Health and Human Services said all the committee members have "undergone an ethics and vetting process," and the agency is "committed to robust, transparent discussions about the products." While the panel is tasked with making recommendations, FDA leadership has the final say on what happens

BrainStorm filed the BLA using the FDAs File Over Protest procedure after the regulator issued a Refuse to File letter in November 2022