FDA picks apart BrainStorm's potential ALS treatment ahead of Wednesday adcomm
The unmet need for patients with the progressive neurodegenerative disease ALS, or amyotrophic lateral sclerosis, is undoubtedly high. But the FDA is drawing the line with BrainStorm’s NurOwn (debamestrocel) in briefing documents released Monday ahead of Wednesday’s advisory committee meeting of outside FDA experts.
The agency explains the BLA for NurOwn that was filed over protest — a rare and often desperate move that sponsors make when they have no other options — after the sponsor received a “refuse to file” letter from the FDA, when the company didn’t file the necessary data in its original application.
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