​Please register for our May 11th rally in Washington, DC: http://www.meetup.com/ALS-Faster-Drug-Approval/events/221529700/ The recent FDA request for Genervon to release confidential data to the public was unprecedented. They have never done anything like it before. Our information is that they did not first contact Genervon privately and ask them to do it, which if true, is entirely inappropriate and may well have been illegal. Genervon appears to have done absolutely nothing wrong. They have complied with every regulatory requirement and submitted all the necessary documents to the FDA. Not a single patient has received GM604 outside FDA sanctioned clinical trials and a single-patient clinical trial (in which one patient got GM604). FDA has always been, and remains, in complete control of GM604. No one is getting the drug now, and no one can get the drug without FDA’s explicit, written approval. Instead of communicating with the company confidentially (as FDA is required to do by law) FDA did something it had never done before – posted a request on its web site for the company to release confidential data that the FDA already has, and again by law, is the sole entity with the authority and responsibility to review it and make a decision. So why did FDA want it made public, and why does it think this is a case of a drug company taking advantage of patients? Is the FDA being told that Genervon is behind our grassroots campaign? If so, whom are they listening to - they are certainly not listening to us? Let's tell Dr. Janet Woodcock, Director of Center of Drug Evaluation and Research, which oversees the Division of Neurology Products that she has to stop playing games and the FDA must contact Genervon about their request to discuss a New Drug Application for GM604. We're in this together, Anthony Carbajal, Bethany Wolfe, Jehad Majed (jmajed@mac.com), Matthew Bellina, Nick Grillo (gm6nick@gmail.com), and the Torrino Family Email Dr. Woodcock at: janet.woodcock@fda.hhs.gov and copy these people: druginfo@fda.hhs.gov richard.moscicki@fda.hhs.gov william.dunn@fda.hhs.gov stephen.ostroff@fda.hhs.gov commissioner@fda.gov eric.bastings@fda.hhs.gov brad_grantz@toomey.senate.gov Grace_Stuntz@help.senate.gov josephine_eckert@murray.senate.gov [WHAT TO SAY - start with any opening you like but be sure to include]: The recent public statement posted on the FDA website that calls upon Genervon to release confidential data to the public is entirely inappropriate and may well be illegal. Genervon has done nothing wrong by seeking your guidance for an AAP application. We see the FDA's statement as an attempt to stall the application for GM604. The ALS patient community has waited too long for the Division of Neurology Products (DNP) to step up and exercise FDA programs that meet an urgent and unmet need. In the 2012 Food and Drug Administration Safety and Innovation Act, Congress told the FDA to apply the Accelerated Approval Program (AAP) more liberally and yet, the DNP has been highly resistant to this directive. While you sit back and wait to communicate with Genervon about the possibility of a New Drug Application (NDA) under AAP, some of us are dying off. But make no mistake, the rest will carry on and every 90 minutes, another person with ALS joins our ranks. The ALS patient community is mobilized and ready to fight until AAP is utilized as intended for ALS. Dr. Woodcock, as Director of the CDER, I want you to contact Genervon today and discuss the NDA under AAP. Know that our campaign has just begun. We are prepared to support any ALS drug developer who requests AAP from the FDA. AAP will provide the same data faster and cost millions of dollars less than a Phase 3 trial.