Fellow Petitioners, Congratulations! We are nearing 120,000 signatures backing our petitions, urging the FDA to agree to Genervon's request that GM604 be immediately approved under the FDA’s “Accelerated Approval Program” (AAP) with Data Surveillance. If the FDA agrees to this request, ALS patients would have rapid access to GM604 without compromising the data collection process. Keep in mind that while we don’t know the exact date of Genervon's meeting with the FDA, we do know that it will take place early this month. If the FDA denies this request, the slow process of getting new, promising treatments to market will continue. GM604 will not make it to market for another three years or so and by then the current generation of ALS patients will die from this horrible disease. ALS patients, their families and friends all agree that they cannot wait for the long drawn out process of drug approval. There’s no time. It is a highly reasonable request from the terminally-ill to try any new drug or treatment that has proven to be safe and show’s the potential to be effective. For those of you not battling ALS, I want you to look at your hands, arms and legs. Imagine not being able to move them. Imagine losing your ability to speak. Imagine losing your ability to breath and swallow. Imagine losing your independence and requiring help with the most fundamental of tasks; brushing your teeth, eating on your own, putting your clothes on and using the bathroom. Imagine losing your ability to communicate with your loved ones. Imagine facing death everyday when you wake up. This is the horror that ALS patients live with everyday. Who with any heart could oppose or refuse to back our petition to make GM604 available now? Through this campaign, it has been disturbing to hear voices of organizations holding on tightly to the drawn out drug approval process of the past. These voices seem to be coming from large pharmaceutical companies rivals to Genervon and the certain ALS "advocacy organizations" that draw funding from those big pharmaceutical companies. We ask the people at these organizations -- not the businesses, but the people. "If it were you or your loved one slowly wasting away, would your opinion be different? Still, while we have been faced with some opposition, we are delighted that the overwhelming majority of individuals and "real" (pro-active) advocacy organizations stand with us in our belief that a change to the status quo needs to take place now...and that Genervon's GM604 fits the bill perfectly. Genervon's GM604 has a very strong indication of efficacy with a huge indication of safety. Our campaign contends that this should be a primary metric for the FDA’s Accelerated Approval Program and that basic metric should be made standard for ALL ALS drugs and treatments going forward. Changing the paradigm for patients' access to potentially life-saving treatments is our ultimate goal. GM604 is the best tool we have to achieve that goal. It is the most promising new treatment to come out in the past two decades. Judging from the number of signatures and the comments on our petitions, people all over the world strongly agree. To update anyone who has been following our request to the ALS Association (ALSA) asking them to support our petitions, please know that: • Data has been submitted to the ALSA per their request on 1-28-2015 • The ALSA has not backed our petitions or given any indication if and when they may make any final decision. If they have, they have not communicated it with us. • After following up with the ALSA on 1-30-2015, our campaign has not heard from the ALSA. At this time, we assume they have decided not to support our petitions. It is incredibly important that we show the FDA how widespread the support for GM6 is -- not just within the ALS community but also with the general public who have been awakened to the harsh realities of ALS. Please take a few minutes to help us make a big push today. 1) Click here to tweet directly to the FDA and tell them you stand with the ALS community and support the approval of GM6: http://ctt.ec/6wa_a 2) Email the FDA directly to voice your support. Share personal stories of how ALS has affected your life and explain why GM6 approval is so desperately needed. (Please make sure to keep it polite and professional--remember we are asking for their help). Please email: druginfo@fda.hhs.gov Copy FDA Commissioner Margaret Hamburg: margaret.hamburg@fda.hhs.gov Copy Dr. William Dunn: william.dunn@fda.hhs.gov 3) Call or Email U.S. Senators who advise the FDA (we made it simple): https://www.change.org/p/food-and-drug-administration-fda-accelerated-approval-of-genervon-s-gm604-for-use-in-als/u/9425621 You can keep track of the campaign on Twitter and Facebook here: https://twitter.com/gm604als https://www.facebook.com/gm604forals If you haven’t already- sign our petition and continue to share it: www.change.org/ALSMedication Thanks to all who are actively campaigning- making this a huge success! Warmest regards, Jehad Majed and Nick Grillo