- cafead Oct 01, 2023 at 01:22: PM
via Amyotrophic lateral sclerosis (ALS), known as Lou Gehrig’s disease, dominated this week’s news. An FDA advisory committee met on Wednesday to consider BrainStorm Cell Therapeutics’ much-debated experimental treatment NurOwn. The adcomm voted 17-1 that NurOwn did not demonstrate substantial evidence of effectiveness in mild to moderate ALS.
However, the near unanimous adcomm vote against BrainStorm’s candidate was not surprising. In briefing documents published Monday, ahead of Wednesday’s meeting, the FDA took issue with the cell therapy’s manufacturing plan and said BrainStorm failed to demonstrate substantial evidence of efficacy in its Biologics License Application. Further, the agency said that upon initial receipt of the BLA, it determined it was “scientifically incomplete” to demonstrate effectiveness, while the manufacturing information it received was “grossly deficient” to ensure adequate quality of the product.
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However, the near unanimous adcomm vote against BrainStorm’s candidate was not surprising. In briefing documents published Monday, ahead of Wednesday’s meeting, the FDA took issue with the cell therapy’s manufacturing plan and said BrainStorm failed to demonstrate substantial evidence of efficacy in its Biologics License Application. Further, the agency said that upon initial receipt of the BLA, it determined it was “scientifically incomplete” to demonstrate effectiveness, while the manufacturing information it received was “grossly deficient” to ensure adequate quality of the product.
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