ARTICLE | Regulation
BrainStorm’s data appear beyond limits of FDA flexibility in ALS
Agency roundly rebuffs ALS candidate NurOwn in briefing materials released ahead of Wednesday’s panel meeting
September 26, 2023 12:10 AM UTC
Even with new biomarker data and efficacy analyses, FDA is still not buying BrainStorm’s argument for efficacy of ALS therapy NurOwn.
In briefing materials released ahead of Wednesday's advisory committee meeting, FDA criticized the company’s post hoc subgroup analyses and emphasized a concerning survival signal...
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