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ALS Treatment Withdrawal: FDA Concerns
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Overview
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BrainStorm Cell Therapeutics withdrew its approval application for NurOwn, an experimental treatment for ALS, after facing significant FDA pushback. The company is now exploring a Phase 3b clinical trial, while the FDA expressed concerns about safety and effectiveness. The share price dropped 5% after the announcement.
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How might the withdrawal of NurOwn's approval application affect the ALS community's access to experimental treatments?
How might the withdrawal of NurOwn's approval application impact the development of other experimental ALS treatments?
What are the ethical considerations surrounding the FDA's concerns about the safety and effectiveness of NurOwn?
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