BrainStorm Cell Therapeutics Announces Publication Calling for Updated FDA Approaches to ALS, Rare Diseases and Regenerative Medicine

▤ Summary

BrainStorm Cell Therapeutics published an article arguing that FDA regulatory frameworks should evolve to keep pace with advances in biomarkers, genomics, AI, cell therapy, and precision medicine. The piece uses ALS as a case study to show how updated evidence standards could improve development paths for rare and fast-moving diseases. It highlights tools such as accelerated approval, adaptive trial design, Bayesian statistics, validated biomarkers, and earlier sponsor-regulator alignment. The company positions its own ALS program and Special Protocol Assessment as evidence that modern regulatory approaches can help move therapies forward.

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