Approve Genervon GM604 for all ALS patients immediately. We request that GM604 be advanced to the Accelerated Approval Program.

The Issue

Video from the FDA explaining the Accelrated Approval Program:

http://youtu.be/fzlePvW-Dg4

Over 30,000 Americans suffer from amyotrophic lateral sclerosis (ALS or Lou Gehrig's Disease) and even more worldwide. 50% of those with ALS will die within 2 years and the majority of the rest will die within 5 years. Words can't describe the devastation this disease causes the patient with ALS and their families. It is the worst disease anyone can get.

Please watch the video in this petition to see first hand how this affects patients and their families.Anthony Carbajal is currently fighting ALS and has lost several family members to the disease. His mother, as you'll see in the video is completely paralyzed. 

http://youtu.be/cK7UUYt_vRI

Since the majority of ALS patients face certain paralyses and death, ALS patients, their families and the general public agree that ALS presents a compelling case for an exception to the usual process. 

Genervon GM604 has demonstrated safety in trials and has demonstrated significant efficacy. ALS patients will die during the time it takes to conduct a Phase 3 trial. Imagine if it was your sibling or child suffering from this disease. Imagine them getting weaker, losing muscle mass, losing the ability to coordinate movement, imagine the despair and fear they feel, losing your ability to speak, swallow and breath. If you were in my shoes you would do almost anything to save your loved one. Help us save my brother Wissam Majed and the thousands of people suffering from ALS. GM604 can stop the progression and save many people. 

Approve Genervon GM604 for all ALS patients immediately. We request that GM604 be advanced the Accelerated Approval Program. We understand that the responsibility of the FDA is to insure that drugs and treatments are safe and effective for the public but in this case patients with ALS are going to die anyways. Please show some compassion approve GM604 immediately.

To learn more about the FDA accelrated approval program please read Paul Aiken's (co-petitioner) blog post:

https://nequals2.com/gm6-breakthrough-basics-how-the-fdas-accelerated-approval-program-works/

Sincerely,

Jehad Majed, the 30,000 ALS patients and their families

This petition had 774,122 supporters

The Issue

Video from the FDA explaining the Accelrated Approval Program:

http://youtu.be/fzlePvW-Dg4

Over 30,000 Americans suffer from amyotrophic lateral sclerosis (ALS or Lou Gehrig's Disease) and even more worldwide. 50% of those with ALS will die within 2 years and the majority of the rest will die within 5 years. Words can't describe the devastation this disease causes the patient with ALS and their families. It is the worst disease anyone can get.

Please watch the video in this petition to see first hand how this affects patients and their families.Anthony Carbajal is currently fighting ALS and has lost several family members to the disease. His mother, as you'll see in the video is completely paralyzed. 

http://youtu.be/cK7UUYt_vRI

Since the majority of ALS patients face certain paralyses and death, ALS patients, their families and the general public agree that ALS presents a compelling case for an exception to the usual process. 

Genervon GM604 has demonstrated safety in trials and has demonstrated significant efficacy. ALS patients will die during the time it takes to conduct a Phase 3 trial. Imagine if it was your sibling or child suffering from this disease. Imagine them getting weaker, losing muscle mass, losing the ability to coordinate movement, imagine the despair and fear they feel, losing your ability to speak, swallow and breath. If you were in my shoes you would do almost anything to save your loved one. Help us save my brother Wissam Majed and the thousands of people suffering from ALS. GM604 can stop the progression and save many people. 

Approve Genervon GM604 for all ALS patients immediately. We request that GM604 be advanced the Accelerated Approval Program. We understand that the responsibility of the FDA is to insure that drugs and treatments are safe and effective for the public but in this case patients with ALS are going to die anyways. Please show some compassion approve GM604 immediately.

To learn more about the FDA accelrated approval program please read Paul Aiken's (co-petitioner) blog post:

https://nequals2.com/gm6-breakthrough-basics-how-the-fdas-accelerated-approval-program-works/

Sincerely,

Jehad Majed, the 30,000 ALS patients and their families

The Decision Makers

Dr. Stephen Ostroff
Dr. Stephen Ostroff
FDA Chief Scientist
Former U.S. Senate
9 Members
Mark Kirk
Former US Senate - Illinois
Orrin G. Hatch
Former US Senate - Utah
Bob Casey
Former U.S. Senate - Pennsylvania
U.S. Senate
3 Members
Michael Bennet
U.S. Senate - Colorado
Timothy Scott
U.S. Senate - South Carolina
Patty Murray
U.S. Senate - Washington
Janet Woodcock, M.D.
FDA Director, Center for Drug Evaluation & Research
Petition updates