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RegMed Investors (RMi) research note: BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) Shut-down by FDA on New Biologics License Application (BLA) for the ALS treatment with NurOwn

November 10, 2022 9:42am

BCLI is down -$1.39 or -48.09% and fluctuating

BCLI has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Biologics License Application (BLA) for NurOwn for the treatment of ALS.

The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.

BCLI intends to request a Type A meeting and looks forward to continued discussions with the FDA," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We continue to believe that NurOwn's Phase 3 trial represents a significant contribution to ALS therapy and will continue to work tirelessly to address the needs of people living with ALS by advancing science and partnering with researchers around the world."

The Bottom Line: I have always believed that BCLI got “ahead of its skis” and off trail. They’re still have a short “runway” and it proves my trepidation.

35 companies, 1 interpreter!

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