Neuigkeit zur PetitionFDA Accelerated Approval of Genervon's GM604 for Use In ALSTell the FDA GM604 is a Perfect Fit for the Accelerated Approval Program
Nicholas GrilloSan Francisco, CA, Vereinigte Staaten
04.03.2015
Several supporters have asked when our petition will be sent. The petition and signatures were sent long before Genervon met with the FDA. When new signatures are added, the FDA, Members of Congress, and the President are automatically updated. This is why we must keep gathering more signatures. Decision makers need to know that we are united and will not stop until we have access to GM604. HUGELY IMPORTANT! Please continue flooding the FDA with your emails. If you have done so already, do so again with the following points in your message: MESSAGE TO FDA: --------------------- 235,000+ people have signed a petition urging the FDA to grant Accelerated Approval with post-marketing requirements for Genervon’s GM604 (www.Change.org/ALSMedication). Our request is based on: 1) Demonstrated Safety 2) Evidence of Efficacy 3) GM604 meets the criteria for the Accelerated Approval Program: 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. GM604 is a perfect fit for the accelerated approval program. Thank you, (your name) -------------------- Email the FDA: druginfo@fda.hhs.gov And cc these people: margaret.hamburg@fda.hhs.gov william.dunn@fda.hhs.gov stephen.ostroff@fda.hhs.gov jim_jeffries@alexander.senate.gov margaret_atkinson@help.senate.gov kristin_chapman@help.senate.gov Elizabeth_Schwartz@help.senate.gov And cc these news shows: news@cbsnewyork.com Viewermail@newshour.org contact.nbcnews@nbcuni.com anderson.cooper@turner.com foxnewstips@foxnews.com Thanks for all your support, Nick Grillo (gm6nick@gmail.com), Jehad Majed ( jmajed@mac.com), and Bethany Wolfe GM604 Campaign Website: https://sites.google.com/site/aap4gm6/ GM604 Facebook page: https://www.facebook.com/gm604forals GM604 Campaign Video: https://www.youtube.com/watch?v=Tdtw3KCnsZk&feature=youtu.be
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