Requests that the FDA Invite the drug sponsor, Brainstorm Cell Therapeutics, to re-file its Biologics License Application (BLA) for debamestrocel (aka NurOwn), a first-in-class, autologous, mesenchymal stem cell therapy enhanced with neurotrophic factors. Approve debamestrocel for ALS, with a Phase 4 study mandating participation in a biorepository with a natural history and exposome database.