Chaim Lebovits, BrainStorm CEO
After rare public brushback, FDA again turns away BrainStorm's ALS drug with RTF letter
As a cell therapy biotech developing a new treatment for ALS attempted to approach the FDA with its application, it found the agency’s doors slammed shut.
BrainStorm Cell Therapeutics received a refusal to file (RTF) letter from regulators, who swatted away the BLA without reviewing it, for its ALS therapy NurOwn, the biotech announced Thursday. The move comes after the FDA, in a rare public slapdown, said in March 2021 that Phase III data were “not at all statistically significant.”
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