“FDA is the 800-pound gorilla here, and if they’re convinced that the drug doesn’t work, it’s very hard to change their minds,” Marc Scheineson, a former associate FDA commissioner who now consults for drugmakers, told the Associated Press. Read More
Source:https://fortune.com/well/2023/09/25/nurown-fda-review-brainstorm-als-lou-gehrigs-disease/