BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says
Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.
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Top-line results from BrainStorm’s NurOwn Phase III ALS study show the cell therapy missed the primary efficacy endpoint, but clinically meaningful responses were seen in a pre-specified subgroup which investigators considered potentially a significant step forward in therapy.
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