For Immediate Release: November 11, 2022
Contact: Sonya Sotak Elling, sonya@iamals.org

Food and Drug Administration Refusal Letter

WASHINGTON – Yesterday, the Food and Drug Administration (FDA) issued a refusal to file letter regarding NurOwn.

“To say that I AM ALS is disappointed that the FDA issued a refusal to file letter regarding NurOwn would be a massive understatement,” said Brian Wallach, founder of I AM ALS.

The ALS community needs clarity on exactly why the agency issued this denial deeming the application incomplete.

Too many people are fighting for their lives against this horrific, deadly disease. We need to ensure that science, urgency, and humaneness drive the development and approval process for new treatments for people living with ALS.