NurOwn is the clearest test yet of how far the agency may be willing to bend to approve a new medicine for a rare and deadly condition with few treatment options.
The meeting was scheduled after ALS advocates delivered a 30,000-signature petition seeking a public vetting of the treatment. "The amazing testimonials we have seen online do not align with the data that Brainstorm has shared," the group said in a statement. NurOwn is made from stem cells collected from patients' bone marrow. The cells are processed in a lab with biological proteins designed to promote nerve growth, and then injected into the spinal column.
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