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Sign the petition to encourage FDA to hold an AdComm for NurOwn


The Honorable Robert M. Califf, MD
Commissioner of Food and Drugs
U.S. Food and Drug Administration

Dr. Peter Marks
Director of the Center for Biologics Evaluation and Research

Dr. Wilson Bryan
Director of the Office of Tissues and Advanced Therapies
FDA’s Center for Biologics Evaluation and Research

Dear Commissioner Califf, Dr. Marks and Dr. Bryan,

We – undersigned people living with Amyotrophic Lateral Sclerosis (ALS), caregivers, advocates and ALS organizations – write to request that you allow NurOwn to proceed to an Advisory Committee meeting.

We understand that the FDA plays a very important role in ensuring that any approved medication is safe and has the chance to help patients. We have seen, however, the way that the FDA’s Oncology Center of Excellence, as well as the Center for Drug Evaluation and Research have exercised regulatory flexibility and urgency. We ask CBER to do the same for ALS.

An Advisory Committee meeting will allow for an independent review of NurOwn as well as the data on efficacy and safety. It is critical for all ALS treatments that they be given the chance to proceed to an AdComm. If not, there will be real inequity in the review process which will undermine trust in the FDA. We want to see a strong, flexible FDA that is part of the process for turning ALS from an always fatal disease to a chronic one.

We thank you for moving NurOwn forward to an AdComm and we look forward to working with you and your team on this drug and many more.

Sincerely,

I AM ALS
Team Gleason
Les Turner ALS Foundation
Compassionate Care ALS
Lisa’s Legacy for ALS
Hop on A Cure
Voices for ALS
ALS ONE
AXE ALS Foundation
The Joe Martin ALS Foundation
Every 90 Minutes
conSLAncio
Your ALS Guide
No More Excuses
A Long Swim
Mary Beth Benison Foundation
ALS In Wonderland Foundation
ALS Hope Foundation
Queen B
HARK ALS

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