Brainstorm Cell Therapeutics Received Written Agreement From FDA, Under Special Protocol Assessment, On Design For Phase 3B Trial Of NurOwn In Amyotrophic Lateral Sclerosis Expected To Start In 2024
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Brainstorm Cell Therapeutics has received a written agreement from the FDA under a Special Protocol Assessment for the design of a Phase 3B trial of NurOwn in Amyotrophic Lateral Sclerosis, expected to start in 2024.
April 09, 2024 | 10:02 am
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Brainstorm Cell Therapeutics' receipt of FDA agreement for the Phase 3B trial design of NurOwn in ALS is a significant regulatory milestone, indicating progress towards potential market approval.
Receiving a written agreement from the FDA under a Special Protocol Assessment is a critical step in the drug development process, indicating that the FDA is in agreement with the trial design. This reduces regulatory risk and increases the likelihood of a successful trial outcome, which can significantly impact the company's stock price in the short term.
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