The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.
by Ned Pagliarulo – Biopharma Dive
A yearslong disagreement between the Food and Drug Administration and a developer of an experimental medicine for ALS will get a public hearing sometime in the future, setting up another high-profile debate of what amount of evidence merits an approval for the progressive and fatal disease.
On Monday, BrainStorm Cell Therapeutics said the agency will convene a panel of outside experts to review its medicine, a personalized stem cell treatment called NurOwn. The planned meeting, which has not yet been scheduled, is the result of BrainStorm taking the rare step of requesting its approval application be filed over the FDA’s protest.
