In this photo provided by I AM ALS, Dan Tate, right, delivers a printed petition from ALS patients and advocates to Dr. Peter Marks, left, director of the Food and Drug Administration's center for biologics at the FDA campus in Silver Spring, Md., on Dec. 14, 2022. The FDA meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal, neurodegenerative disease. Those advocates still face one giant hurdle: FDA regulators say the treatment hasn't been shown to work. In documents posted Monday, Sept. 25, 2023 the FDA reiterated its longstanding position: drugmaker Brainstorm's lone study doesn't provide clear evidence that its stem cell-based therapy helps patients with ALS, or amyotrophic lateral sclerosis. (Sonya Elling/I AM ALS via AP)