BrainStorm Cell Therapeutics Inc (BCLI)

[Fmello]

https://www.biospace.com/article/fda-reverses-course-on-nda-submission-for-amylyx-als-drug-/

The decision, which came on the heels of the FDA’s refusal of Brainstorm Cell Therapeutics Inc.’s NurOwn – another drug with arguably more going for it than Aduhelm – sparked anger in the ALS community. This was particularly true because the drug demonstrated evidence of a clinically significant response in a pre-specified subgroup of patients with early-stage disease based on the ALS Functional Rating Scale.

“The ALS community has been demanding the same regulatory flexibility for AMX0035 and NurOwn. The FDA needs to do the same thing for ALS as they did for Alzheimer’s,” Nicole Cimbura, whose husband lost his battle to ALS in 2019, told BioSpace in a previous interview.