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BrainStorm Cell Therapeutics Inc.

http://www.brainstorm-cell.com

Latest From BrainStorm Cell Therapeutics Inc.

With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

Approvals Drug Review

BrainStorm Hoping For Advisory Committee After FDA Refuses To File BLA For Its ALS Cell Therapy

BrainStorm, which has a history of antagonizing FDA with direct appeals to patients for NurOwn, tells investors that public elements of an adcomm could be ‘persuasive,’ but first step will be formal meeting request to try to overcome the RTF. Firm sees Relyvrio as template for success.

Neurology Drug Approval Standards

ALS Drugs: FDA May Adjust Development Recommendations In Real Time For Ongoing Programs

Agency’s action plan for rare neurodegenerative diseases maps out over five years, but knowledge gained can inform products currently in development; new FDA grant program looks to invest in remote use of clinical outcome assessments for amyotrophic lateral sclerosis.

Drug Approval Standards Rare Diseases

ALS ‘Urgency’, US FDA Regulatory Environment Justify Filing NurOwn, BrainStorm Says

BrainStorm discovered a statistical error while preparing the stem cell therapy's BLA, and corrected data show a statistically significant treatment difference for a key secondary endpoint in less advanced ALS. However, the Phase III trial still failed its primary clinical efficacy endpoint.

Drug Review Clinical Trials
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