Last year, the Food and Drug Administration issued a rare public statement to inform the ALS community that a negative clinical trial involving an experimental stem-cell therapy from Brainstorm Cell Therapeutics did not support the filing of a marketing application.
On Monday, Brainstorm announced its intention to seek approval from the FDA for its ALS treatment, called NurOwn, regardless of the agency’s past opposition.
“We have always believed that NurOwn delivers meaningful clinical benefit for ALS patients,” Stacy Lindborg, Brainstorm’s head of global clinical research, told STAT. Filing with the FDA is the “correct and appropriate step based on the data we have.”
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