BCLI: FDA Meeting Provides Clear Path for Planned Phase 3b Trial of NurOwn
NASDAQ:BCLI
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Business Update
Clear Path Forward for Phase 3b Trial of NurOwn
On December 7, 2023, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) announced the company attended a meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3b trial for NurOwn in amyotrophic lateral sclerosis (ALS). The company is going to be submitting a Special Protocol Assessment (SPA), which is a process by which a drug developer meets with the FDA to reach agreement on certain aspects of a clinical trial design that could support marketing approval. During the meeting with BrainStorm, the FDA provided constructive feedback regarding the design of the Phase 3b trial. After talking with management, we believe the company is on an expedited pathway to getting a SPA, which normally can take over a year. The FDA is working cooperatively with BrainStorm as the agency and company both recognize the urgent need to get additional effective therapies to ALS patients as quickly as possible. We view a SPA as an important means to de-risk certain parts of the regulatory pathway for NurOwn.
Conclusion
We’re very encouraged to hear about the positive meeting with the FDA and the agency’s willingness to work with BrainStorm to expeditiously get the Phase 3b trial underway. While we are unsure of an exact timeframe for the company to acquire the SPA, the fact that management believes it is on an expedited pathway leads us to believe that it will be quicker than the typical year-long process. We eagerly await additional updates from BrainStorm as it prepares the Phase 3b trial protocol and submits the necessary documentation to secure a SPA. With no changes to our model our valuation remains at $0.50 per share.
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