Grant widespread access to Genervon's GM604 to all ALS Patients
The Issue
I am a 31-year-old Navy veteran living with ALS. I am a husband and the father of two small boys. I want to be there for them as they grow up. I want to teach them how to throw a baseball and take them camping.
Veterans are twice as likely to develop ALS, and scientists have yet to discover why.
The U.S. Department of Veterans Affairs recognizes ALS as a service-connected disease. This disease is exorbitantly expensive to manage and is costing the VA hundreds of millions of dollars every year. It is estimated it would be less expensive to cure the disease than it would be to manage and compensate patients for the average two to five year lifespan of patients post diagnosis.
Study after study continues to demonstrate this to be true: If you serve in the military, regardless of the branch of service, regardless of whether you served in the Persian Gulf War, Vietnam, Korea, or World War II, and regardless of whether you served during a time of peace or a time of war, you are at a greater risk of dying from ALS than if you had not served in the military.
A breakthrough in ALS treatment has been a long time coming. Lou Gehrig died of the disease 75 years ago and since then we have only had one treatment option for this horrible illness. That option is Rilutek, which only extends life expectancy by a couple months. Rilutek was approved 20 years ago. That's right, no new treatments in 20 years!
As I battle my illness, I also have hope because I have recently become aware of a new treatment GM604 that has shown positive results in ALS patients. The manufacturer, Genervon, has applied to the FDA for Accelerated Approval with post-marketing requirements for their new treatment. If the FDA denies this request, GM604 will most likely have to undergo another clinical trial before it reaches the population of ALS sufferers. That means the current generation of those with ALS will have died by the time GM604 reaches market.
Alternately, by granting this request, approximately 30,000 Americans, many of whom are Armed Forces Veterans, will have fast access to this potentially life changing treatment. The manufacturer can not reasonably be expected to provide this treatment through compassionate use and other expedited access programs. How could they offer access to 30,000 people, individual by individual through such time consuming and costly programs? Additionally, this FDA approval can also expedite approval in many foreign countries.
I am asking for the help of my fellow veterans and non-veterans alike to convince the FDA that we should be allowed immediate access to this treatment as ALS is a terminal illness with no viable treatment options and GM604 meets all the criteria for the Accelerated Approval Program.
By signing this petition you will be helping me and many people with ALS.
Thank you

The Issue
I am a 31-year-old Navy veteran living with ALS. I am a husband and the father of two small boys. I want to be there for them as they grow up. I want to teach them how to throw a baseball and take them camping.
Veterans are twice as likely to develop ALS, and scientists have yet to discover why.
The U.S. Department of Veterans Affairs recognizes ALS as a service-connected disease. This disease is exorbitantly expensive to manage and is costing the VA hundreds of millions of dollars every year. It is estimated it would be less expensive to cure the disease than it would be to manage and compensate patients for the average two to five year lifespan of patients post diagnosis.
Study after study continues to demonstrate this to be true: If you serve in the military, regardless of the branch of service, regardless of whether you served in the Persian Gulf War, Vietnam, Korea, or World War II, and regardless of whether you served during a time of peace or a time of war, you are at a greater risk of dying from ALS than if you had not served in the military.
A breakthrough in ALS treatment has been a long time coming. Lou Gehrig died of the disease 75 years ago and since then we have only had one treatment option for this horrible illness. That option is Rilutek, which only extends life expectancy by a couple months. Rilutek was approved 20 years ago. That's right, no new treatments in 20 years!
As I battle my illness, I also have hope because I have recently become aware of a new treatment GM604 that has shown positive results in ALS patients. The manufacturer, Genervon, has applied to the FDA for Accelerated Approval with post-marketing requirements for their new treatment. If the FDA denies this request, GM604 will most likely have to undergo another clinical trial before it reaches the population of ALS sufferers. That means the current generation of those with ALS will have died by the time GM604 reaches market.
Alternately, by granting this request, approximately 30,000 Americans, many of whom are Armed Forces Veterans, will have fast access to this potentially life changing treatment. The manufacturer can not reasonably be expected to provide this treatment through compassionate use and other expedited access programs. How could they offer access to 30,000 people, individual by individual through such time consuming and costly programs? Additionally, this FDA approval can also expedite approval in many foreign countries.
I am asking for the help of my fellow veterans and non-veterans alike to convince the FDA that we should be allowed immediate access to this treatment as ALS is a terminal illness with no viable treatment options and GM604 meets all the criteria for the Accelerated Approval Program.
By signing this petition you will be helping me and many people with ALS.
Thank you

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Petition created on April 2, 2015
