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Petitioning FDA Director, Center for Drug Evaluation & Research Janet Woodcock, M.D. and 23 others

Accelerated Approval for GM604

Hello everyone, my name is Anthony Carbajal and my mom and I are both living with a devastating neurological disease called ALS. You may have seen my recent viral video that caught the world's attention... even Ellen’s attention. In my video I described the urgency to find a viable treatment and how we desperately need support.

ALS is currently an incurable, progressive, degenerative neurological disorder and is designated as a terminal illness. For reasons that are still not completely understood, the nerve cells in my brain and spinal cord are gradually deteriorating. As a result, ALS patients like me slowly lose the ability to move, speak, swallow, and finally… to breathe. ALS leads to complete paralysis, and the average life expectancy from diagnosis is 2-5 years. 

Right now there is no viable treatment option for this terminal illness. The only FDA approved treatment is a drug called Riluzole, which extends life expectancy by a few months with no improvement to the quality of life. The really alarming part is that Riluzole was approved 20 years ago and nothing new has been made available since then!

There is a new drug called GM6, that is currently being evaluated by the FDA. According to Genervon, the company making the drug, "Preclinical, Phase 1, and Phase 2A data all demonstrate the safety and efficacy of GM6." There were no negative side effects from the treatment, and most importantly, the differences in outcomes between the group of trial patients given the placebo and those given GM6 were "statistically significant" - even though the trials were small and not even set up to produce such dramatic results!

Genervon met with the FDA in early February 2015 and asked that GM6 be granted Accelerated Approval, which would mean that the drug would be made available to all ALS patients immediately. The FDA will make a decision by mid-April, which is why it is so important that we act now. 

Thousands of ALS patients and myself want to be able to try this drug. I do not have any other options to fight.

 I don’t want to be just another statistic. Please sign our petition urging the FDA to grant accelerated approval for GM604. We can’t do this without YOUR participation and help! I honestly believe we’re stronger together. Thank you for your time and consideration.

This petition was delivered to:
  • FDA Director, Center for Drug Evaluation & Research
    Janet Woodcock, M.D.
  • FDA Acting Director, Office of Drug Evaluation
    William Dunn, M.D. (FDA Acting Director, Office of Drug Evaluation)
  • FDA Deputy Center Director, Clinical Science
    Robert Temple, M.D. (FDA Deputy Center Director, Clinical Science)
  • FDA, Director, Office of New Drugs
    John Jenkins, M.D. (FDA, Director, Office of New Drugs)
  • FDA Director, Office of Strategic Programs
    Theresa M. Mullin, Ph.D. (FDA Director, Office of Strategic Programs)
  • FDA Chief Scientist
    Stephen Ostroff, M.D. (FDA Chief Scientist)
  • Senator
    Bernie Sanders
  • FDA Director, Center for Drug Evaluation & Research
    Janet Woodcock, M.D. (FDA Director, Center for Drug Evaluation & Research)
  • FDA Deputy Commissioner
    Robert Califf, M.D.
  • Senator
    Sheldon Whitehouse
  • Senator
    Richard Burr
  • Senator
    Ron Wyden
  • Senator
    Mark Warner
  • Senator
    Tom Carper
  • Senator
    Lamar Alexander
  • Senator
    Patty Murray
  • Senator
    Elizabeth Warren
  • Senator
    Bernie Sanders
  • Senator
    Mark Kirk
  • Senator
    Rand Paul
  • Senator
    Tammy Baldwin
  • Senator
    Lisa Murkowski
  • Deputy Director of CDER Center
    Rich Moscicki
  • FDA
    Eric Bastings

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