Despite red flag from FDA, controversial ALS cell therapy developer says it may still march ahead anyway
When BrainStorm Cell Therapeutics broke out the abysmal numbers in its Phase III trial, the biotech insisted that the FDA was eager to review the data — given the signal they had identified in a subgroup of amyotrophic lateral sclerosis with less advanced disease.
Three months later, regulators did give a look to the high-level summary of the data. But they didn’t have too many good things to say.
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