In this update: 1) Rally – Washington DC, May 11, 2015 2) Welcome New Campaigners 3) Email/call FDA and Congress - Last Chance? 1) Our grassroots campaign has adopted the moniker, "Hope NOW for ALS" and our mission, in addition to gaining access to GM604, is to gain access to ALL promising treatments for ALS, and help to redesign the clinical trial process for ALS treatments. It is very important for everyone to join us at the next Washington, DC Rally during ALS Awareness Month on Monday, May 11th. Register at the link below. We need ALL of you! Together we can change the status quo and start saving the current generation of people with ALS. http://www.meetup.com/ALS-Faster-Drug-Approval/events/221529700/ 2) The campaign welcomes Lt. Commander Matt Bellina and family to our campaign. Matt is a veteran, who has been diagnosed with ALS. Last week he posted a sister-petition that, with the help from our supporters at Change.org, has at this time generated 142,000 new signatures. Matt’s petition can be found @ www.change.org/ALSMedication6. In the week ahead, Matt’s petition will be linked with the others and the new signatures will be added to the grand total. Since all petitions found on Change.org for Accelerated Approval of GM604 ask for the same thing, as soon as you sign one petition your signature is applied to all the others as well. If you do sign more than one, Change.org filters out the duplicate signatures for us. Anyone with questions about the campaign can always email Nick Grillo @ gm6nick@gmail.com and/or Jehad Majed @ jmajed@mac.com. 3) We expect a response from the FDA before the end of the month. This may be our last chance to influence their decision. We know the FDA’s Accelerated Approval Program is a far better option than a Phase 3 trial for many reasons and we’re pointing out why in this mass email to both the FDA and Congress. Here are this week’s instructions for sending emails: Below you’ll first find “WHAT TO SAY”, then a copy and paste “EMAIL ADRESSES FOR FDA”, and below that a “US SENATORS” list with links to their “contact me” page (as well as phone numbers). If you get a response from your senator please share it with us. Emails and phone calls to Senators should always include an action item – ask Congress to demonstrate support by including the following: “I would like you to contact the FDA and tell them that the ALS Community is in urgent need of a viable treatment option. All applications for Accelerated Approval must be given full and fair consideration.” WHAT TO SAY [Share your personal story or just mention that you support the ALS Community in their efforts to see that the FDA accepts Genervon’s application for “Accelerated Approval with post-marketing requirements”. Understand that the Accelerated Approval Program is not the same as “compassionate use” or “fast track”. The FDA is very particular about terminology. Email us if you have questions.] Be sure to end your email with the following: The FDA’s 1992 Accelerated Approval Program (AAP) is an appropriate and preferable next step for Genervon’s GM604 because: 1. There is an urgent and unmet need to get a viable treatment to People with ALS (PALS). The only option at this time is Rilutek, which extends life expectancy by a few months with no improvement to quality of life. The average life expectancy for PALS is 2-5 years. So by the time another clinical trial for GM604 is completed, the majority of the current generation of PALS will be dead. Rilutek was approved 20 years ago – there have been no new treatment options in 20 years. AAP was designed to meet the needs of populations just like the ALS Community. 2. GM604 is a 6-amino acid endogenous peptide. It is very safe and tolerable as shown in Phase 1 (32 subjects), ALS Phase 2A (12 subjects), Parkinson’s Disease Phase 2A (6 subjects), Stroke (28 of 36 subjects, not yet un-blinded). Adverse events and serious adverse events were comparable to placebo, with no reported drug related clinically serious adverse events. 3. The common clinical trial design limits patient inclusion to those exhibiting an "average" disease progression and those in the early stages of the disease. Accelerated Approval with post-marketing requirements would provide data from a greater cross-section of patients at all stages of the disease. 4. AAP for GM604 has the ability to gather more data sooner and at far lower cost than a Phase 3 trial. Post-marketing requirements could include several focused single arm trials designed to ask specific questions regarding correlation of clinical outcomes and biomarker responses, and a patient registry to capture more limited but still meaningful data from a larger population of patients (but not necessarily all) receiving GM604. EMAIL ADDRESSES FOR FDA Email the FDA at: druginfo@fda.hhs.gov and cc these people: richard.moscicki@fda.hhs.gov janet.woodcock@fda.hhs.gov william.dunn@fda.hhs.gov stephen.ostroff@fda.hhs.gov commissioner@fda.gov US SENATORS Alabama Sessions, Jeff - (R - AL) (202) 224-4124 http://www.sessions.senate.gov/public/index.cfm/contact-jeff Shelby, Richard C. - (R - AL) (202) 224-5744 http://www.shelby.senate.gov/public/index.cfm/emailsenatorshelby Alaska Murkowski, Lisa - (R - AK) 202) 224-6665 http://www.murkowski.senate.gov/public/index.cfm/emaillisa Sullivan, Daniel - (R - AK) (202) 224-3004 http://www.sullivan.senate.gov/content/contact-dan Arizona Flake, Jeff - (R - AZ) (202) 224-4521 http://www.flake.senate.gov/public/index.cfm/contact-jeff McCain, John - (R - AZ) (202) 224-2235 http://www.mccain.senate.gov/public/index.cfm/contact-form Arkansas Boozman, John - (R - AR) (202) 224-4843 http://www.boozman.senate.gov/public/index.cfm/e-mail-me Cotton, Tom - (R - AR) 202) 224-2353 http://www.cotton.senate.gov/content/contact-tom California Boxer, Barbara - (D - CA) (202) 224-3553 https://www.boxer.senate.gov/contact/shareyourviews.html Feinstein, Dianne - (D - CA) (202) 224-3841 https://www.feinstein.senate.gov/public/index.cfm/e-mail-me Colorado Bennet, Michael F. - (D - CO) (202) 224-5852 http://www.bennet.senate.gov/?p=contact Gardner, Cory - (R - CO) (202) 224-5941 http://www.gardner.senate.gov/content/contact-cory Connecticut Blumenthal, Richard - (D - CT) (202) 224-2823 https://www.blumenthal.senate.gov/contact Murphy, Christopher - (D - CT) (202) 224-4041 http://www.murphy.senate.gov/contact Delaware Carper, Thomas R. - (D - DE) (202) 224-2441 http://www.carper.senate.gov/public/index.cfm/email-senator-carper Coons, Christopher A. - (D - DE) (202) 224-5042 http://www.coons.senate.gov/contact/ Florida Nelson, Bill - (D - FL) (202) 224-5274 http://www.billnelson.senate.gov/contact-bill Rubio, Marco - (R - FL) (202) 224-3041 http://www.rubio.senate.gov/public/index.cfm/email-senator-rubio?p=Contact Georgia Isakson, Johnny - (R - GA) (202) 224-3643 http://www.isakson.senate.gov/public/index.cfm/email-me Perdue, David - (R - GA) (202) 224-3521 http://www.perdue.senate.gov/content/contact-david Hawaii Hirono, Mazie K. - (D - HI) (202) 224-6361 http://www.hirono.senate.gov/contact/email Schatz, Brian - (D - HI) (202) 224-3934 http://www.schatz.senate.gov/contact Idaho Crapo, Mike - (R - ID) (202) 224-6142 http://www.crapo.senate.gov/contact/email.cfm Risch, James E. - (R - ID) (202) 224-2752 http://www.risch.senate.gov/public/index.cfm/email Illinois Durbin, Richard J. - (D - IL) (202) 224-2152 http://www.durbin.senate.gov/contact/email Kirk, Mark - (R - IL) (202) 224-2854 http://www.kirk.senate.gov/?p=comment_on_legislation Indiana Coats, Daniel - (R - IN) (202) 224-5623 http://www.coats.senate.gov/contact/ Donnelly, Joe - (D - IN) (202) 224-4814 http://www.donnelly.senate.gov/contact/email-joe Iowa Ernst, Joni - (R - IA) (202) 224-3254 http://www.ernst.senate.gov/content/contact-joni Grassley, Chuck - (R - IA) (202) 224-3744 http://www.grassley.senate.gov/constituents/questions-and-comments Kansas Moran, Jerry - (R - KS) (202) 224-6521 http://www.moran.senate.gov/public/index.cfm/e-mail-jerry Roberts, Pat - (R - KS) (202) 224-4774 http://www.roberts.senate.gov/public/index.cfm?p=EmailPat Kentucky McConnell, Mitch - (R - KY) (202) 224-2541 http://www.mcconnell.senate.gov/public/index.cfm?p=ContactForm Paul, Rand - (R - KY) (202) 224-4343 http://www.paul.senate.gov/?p=contact Louisiana Cassidy, Bill - (R - LA) (202) 224-5824 http://www.cassidy.senate.gov/content/contact-bill Vitter, David - (R - LA) (202) 224-4623 http://www.vitter.senate.gov/contact/email-senator-vitter Maine Collins, Susan M. - (R - ME) (202) 224-2523 http://www.collins.senate.gov/public/index.cfm/email King, Angus S., Jr. - (I - ME) (202) 224-5344 http://www.king.senate.gov/contact Maryland Cardin, Benjamin L. - (D - MD) (202) 224-4524 http://www.cardin.senate.gov/contact/ Mikulski, Barbara A. - (D - MD) (202) 224-4654 http://www.mikulski.senate.gov/contact Massachusetts Markey, Edward J. - (D - MA) (202) 224-2742 http://www.markey.senate.gov/contact Warren, Elizabeth - (D - MA) (202) 224-4543 http://www.warren.senate.gov/?p=email_senator Michigan Peters, Gary - (D - MI) (202) 224-6221 http://www.peters.senate.gov/content/contact-gary Stabenow, Debbie - (D - MI) (202) 224-4822 http://www.stabenow.senate.gov/?p=contact Minnesota Franken, Al - (D - MN) (202) 224-5641 http://www.franken.senate.gov/?p=email_al Klobuchar, Amy - (D - MN) (202) 224-3244 http://www.klobuchar.senate.gov/public/email-amy Mississippi Cochran, Thad - (R - MS) (202) 224-5054 http://www.cochran.senate.gov/public/index.cfm/email-me Wicker, Roger F. - (R - MS) (202) 224-6253 http://www.wicker.senate.gov/public/index.cfm/contact Missouri Blunt, Roy - (R - MO) (202) 224-5721 http://www.blunt.senate.gov/public/index.cfm/contact-roy McCaskill, Claire - (D - MO) (202) 224-6154 http://www.mccaskill.senate.gov/contact Montana Daines, Steve - (R - MT) (202) 224-2651 http://www.daines.senate.gov/content/contact-steve Tester, Jon - (D - MT) (202) 224-2644 http://www.tester.senate.gov/?p=email_senator Nebraska Fischer, Deb - (R - NE) (202) 224-6551 http://www.fischer.senate.gov/public/?p=email-deb Sasse, Ben - (R - NE) (202) 224-4224 http://www.sasse.senate.gov/content/contact-ben Nevada Heller, Dean - (R - NV) (202) 224-6244 http://www.heller.senate.gov/public/index.cfm/contact-form Reid, Harry - (D - NV) (202) 224-3542 http://www.reid.senate.gov/contact New Hampshire Ayotte, Kelly - (R - NH) (202) 224-3324 http://www.ayotte.senate.gov/?p=contact Shaheen, Jeanne - (D - NH) (202) 224-2841 http://www.shaheen.senate.gov/contact/ New Jersey Booker, Cory A. - (D - NJ) (202) 224-3224 http://www.booker.senate.gov/?p=contact Menendez, Robert - (D - NJ) (202) 224-4744 http://www.menendez.senate.gov/contact New Mexico Heinrich, Martin - (D - NM) (202) 224-5521 http://www.heinrich.senate.gov/contact/write-martin Udall, Tom - (D - NM) (202) 224-6621 http://www.tomudall.senate.gov/?p=contact New York Gillibrand, Kirsten E. - (D - NY) (202) 224-4451 http://www.gillibrand.senate.gov/contact/ Schumer, Charles E. - (D - NY) (202) 224-6542 http://www.schumer.senate.gov/contact/email-chuck North Carolina Burr, Richard - (R - NC) (202) 224-3154 http://www.burr.senate.gov/public/index.cfm?FuseAction=Contact.ContactForm Tillis, Thom - (R - NC) (202) 224-6342 http://www.tillis.senate.gov/content/contact-thom North Dakota Heitkamp, Heidi - (D - ND) (202) 224-2043 http://www.heitkamp.senate.gov/public/index.cfm/email-heidi Hoeven, John - (R - ND) (202) 224-2551 http://www.hoeven.senate.gov/public/index.cfm/email-the-senator Ohio Brown, Sherrod - (D - OH) (202) 224-2315 http://www.brown.senate.gov/contact Portman, Rob - (R - OH) (202) 224-3353 https://www.portman.senate.gov/public/index.cfm/contact-form Oklahoma Inhofe, James M. - (R - OK) (202) 224-4721 http://www.inhofe.senate.gov/contact Lankford, James - (R - OK) (202) 224-5754 http://www.lankford.senate.gov/content/contact-james Oregon Merkley, Jeff - (D - OR) (202) 224-3753 http://www.merkley.senate.gov/contact Wyden, Ron - (D - OR) (202) 224-5244 http://www.wyden.senate.gov/contact Pennsylvania Casey, Robert P., Jr. - (D - PA) (202) 224-6324 http://www.casey.senate.gov/contact Toomey, Patrick J. - (R - PA) (202) 224-4254 http://www.toomey.senate.gov/?p=contact Rhode Island Reed, Jack - (D - RI) (202) 224-4642 http://www.reed.senate.gov/contact/email Whitehouse, Sheldon - (D - RI) (202) 224-2921 http://www.whitehouse.senate.gov/contact/ South Carolina Graham, Lindsey - (R - SC) (202) 224-5972 http://www.lgraham.senate.gov/public/index.cfm?FuseAction=Contact.EmailSenatorGraham Scott, Tim - (R - SC) (202) 224-6121 http://www.scott.senate.gov/contact/email-me South Dakota Rounds, Mike - (R - SD) (202) 224-5842 http://www.rounds.senate.gov/content/contact-mike Thune, John - (R - SD) (202) 224-2321 http://www.thune.senate.gov/public/index.cfm/contact Tennessee Alexander, Lamar - (R - TN) (202) 224-4944 http://www.alexander.senate.gov/public/index.cfm/email Corker, Bob - (R - TN) (202) 224-3344 http://www.corker.senate.gov/public/index.cfm/emailme Texas Cornyn, John - (R - TX) (202) 224-2934 http://www.cornyn.senate.gov/public/index.cfm?p=ContactForm Cruz, Ted - (R - TX) (202) 224-5922 http://www.cruz.senate.gov/?p=email_senator Utah Hatch, Orrin G. - (R - UT) (202) 224-5251 http://www.hatch.senate.gov/public/index.cfm/email-orrin Lee, Mike - (R - UT) (202) 224-5444 http://www.lee.senate.gov/public/index.cfm/contact Vermont Leahy, Patrick J. - (D - VT) (202) 224-4242 https://www.leahy.senate.gov/contact/ Sanders, Bernard - (I - VT) (202) 224-5141 http://www.sanders.senate.gov/contact/comment Virgina Kaine, Tim - (D - VA) (202) 224-4024 https://www.kaine.senate.gov/contact Warner, Mark R. - (D - VA) (202) 224-2023 http://www.warner.senate.gov/public/index.cfm?p=ContactPage Washington Cantwell, Maria - (D - WA) (202) 224-3441 http://www.cantwell.senate.gov/public/index.cfm/email-maria Murray, Patty - (D - WA) (202) 224-2621 http://www.murray.senate.gov/public/index.cfm/contactme West Virginia Capito, Shelley Moore - (R - WV) (202) 224-6472 http://www.capito.senate.gov/content/contact-shelley Manchin, Joe, III - (D - WV) (202) 224-3954 http://www.manchin.senate.gov/public/index.cfm/contact-form Wisconsin Baldwin, Tammy - (D - WI) (202) 224-5653 http://www.baldwin.senate.gov/contact Johnson, Ron - (R - WI) (202) 224-5323 http://www.ronjohnson.senate.gov/public/index.cfm/email-the-senator Wyoming Barrasso, John - (R - WY) (202) 224-6441 http://www.barrasso.senate.gov/public/index.cfm/contact-form Enzi, Michael B. - (R - WY) (202) 224-3424 http://www.enzi.senate.gov/public/index.cfm/e-mail-senator-enzi