A US Food and Drug Administration advisory committee resoundingly concluded that BrainStorm Cell Therapeutics Inc. has not proven NurOwn (debamestrocel) is effective in treating amyotrophic lateral sclerosis, with panelists going well beyond just the clinical data in identifying problems with the application.
BrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel
In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.
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