Food and Drug Administration scientists have “major concerns” with an application filed by biotechnology company BrainStorm Cell Therapeutics for approval of a personalized stem cell treatment for amyotrophic lateral sclerosis, documents posted online Monday show.
According to the documents, FDA staff found BrainStorm’s approval application, filed last September, to be “scientifically incomplete.” They also determined the company’s manufacturing data were “grossly deficient,” and cited missing biomarker results in dismissing after-the-fact analyses that BrainStorm conducted to support its application.
