On March 30, 2022, Amylyx Pharmaceuticals and the FDA will speak to an Advisory Committee about the data from a Phase 2 trial of the investigational ALS drug, AMX0035. As part of this process, the FDA has requested input from the ALS community to inform its decision on whether to approve the drug for commercial use. In the bleak landscape of current ALS therapies, this represents an important and unique opportunity for us to tell the FDA what a new safe and effective treatment would mean to the ALS community! Amylyx and the FDA will speak to the Advisory Committee about the data, noting all key results.
We as a community have an important opportunity to bring life and meaning to the numbers. Help us tell the panel in personal, powerful, real-life terms what a 2-point change on the ALSFRS-R scale and additional 6.5 months of life means to you as someone living with, caring for, or loving someone with ALS.
Statements to the Advisory Panel are due on March 16, 2022.