Petition update

GM604 Campaign Update April 10, 2015

Nicholas Grillo
San Francisco, CA, United States

Apr 12, 2015 — 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. This week he posted a sister-petition that, with the help from our supporters at Change.org, has at this time generated 87,000 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


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