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Saturday, 12/02/2023 6:40:50 PM

Saturday, December 02, 2023 6:40:50 PM

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"In early December, we look forward to reporting topline clinical results from our Phase 2b ALS study. We believe that positive results would offer substantial hope to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval," stated NeuroSense's CEO, Alon Ben-Noon. In November 2023, NeuroSense completed the 6-month double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, 96% of participants who completed the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension. All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC.

https://neurosense.investorroom.com/2023-11-28-NeuroSense-Announces-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update

This part is huge: "All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC." They could convince FDA to go directly for approval.
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