BCLI - BrainStorm gets FDA panel meeting to discuss declined filing for ALS drug NurOwn

• BrainStorm Cell Therapeutics ( NASDAQ: BCLI ) said the U.S. Food and Drug Administration (FDA) granted a Type A meeting to discuss a letter issued by the agency which had declined to accept the company's application seeking approval of NurOwn to treat amyotrophic lateral sclerosis (ALS).
• The Type A meeting is scheduled for Jan. 11, 2023.
• In November, the FDA had issued a refusal to file letter in which it declined to accept the company's new biologics license application (BLA) for NurOwn.
• "We believe that an Advisory Committee Meeting would serve as an important part of the review process and would provide an open forum f r BrainStorm, together with medical experts, statisticians, patients and other members of the ALS community to discuss the body of clinical evidence supporting NurOwn," said BrainStorm
• ALS is a progressive nervous system disorder affecting nerve cells in the brain and spinal cord, leading to loss of muscle control.

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