Brainstorm Cell Therapeutics announced the conclusion of a significant meeting with the #FDA regarding NurOwn, a new innovative treatment for #ALS. This critical meeting aimed at securing a protocol for a Phase 3b trial. It marks a key milestone in the development of the MSC-NTF cell-based #NurOwn, offering a new, personalized approach to #ALStreatment.
Chaim Lebovits, President and CEO of #BrainStorm, emphasized the significance of the meeting outcomes, stating: “Our meeting with the FDA provided us with valuable input on the Phase 3b trial design, outlining clear steps forward. We believe that an SPA will serve to help de-risk certain regulatory aspects of the NurOwn clinical program. We recognize the urgency in providing ALS patients with safe and efficacious treatments and are committed to agreeing on a regulatory path forward for NurOwn.”
By Tracy Mokwe
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