Petition updateFDA Accelerated Approval of Genervon's GM604 for Use In ALSMeteorologist Chris Justus drives campaign full speed ahead!
Nicholas GrilloSan Francisco, CA, United States
2 Mar 2015
Thank you Chris Justus at WYFF Ch4 News! Your support propelled the campaign forward with tons of signatures from NC and SC over the weekend. And guess what? Both of these states have a Senator on the HELP Committee, which advises the FDA. Over the next couple days, let’s all reach out to them. NC – Richard Burr (R) 202-224-3154 http://www.burr.senate.gov/public/index.cfm?FuseAction=Contact.ContactForm SC – Tim Scott (R) 202-224-6121 http://www.scott.senate.gov/contact/email-me MESSAGE TO SENATORS: For the past month, people from all over the world have been urging the FDA to grant Accelerated Approval with post-marketing requirements for a new ALS treatment, Genervon’s GM604. This request is based on: 1) Demonstrated Safety 2) Evidence of Efficacy 3) GM604 meets the criteria for the Accelerated Approval Program (AAP): a. Surrogate Endpoints: Genervon's Phase 2A trials showed improvements in the treated group in both clinical measurements and multiple biomarker measurements. b. Urgent and Unmet Need: No new treatment for ALS has been approved since Rilutek in 1995, which extends life expectancy by a few months with no improvement to quality of life. Another multi-year clinical trial for GM604 is a death sentence for more than 500,000 people. Our FDA is under the jurisdiction of the HELP Committee. Therefore it is ultimately our elected officials’ responsibility to ensure that the right of life and personal liberties of terminally ill patients are protected. This includes the right of these patients to access safe and potentially life saving treatments. In your capacity as a member of the HELP Committee, you have a responsibility to all American citizens, not only your constituents. Please contact the FDA today and ensure that Genervon’s GM604 is being given full and fair consideration for the Accelerated Approval Program.
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