Rally in D.C. and Email the FDA Update


Pioneer Founding member

Nicholas Grillo
San Francisco, CA
Mar 24, 2015 — Congratulations petitioners,

With the help of Anthony Carbajal, whose Ice Bucket Challenge video (watch here: https://www.youtube.com/watch?v=h07OT8p8Oik) went viral with nearly 16.5 million views, and a push from our friends at Change.org, we have reached nearly half a million signatures! Pretty great stuff!

During tomorrow's event, Change.org will be live-tweeting the rally in Washington, D.C. using the hashtag #FDAHope4ALS this way everyone not attending can follow along. They will also be posting photos and videos during the event and after. You can also check in on our Facebook page: https://www.facebook.com/gm604forals.

While our supporters are fighting for us in D.C, we want everyone who is unable to attend the event to email the FDA (details below). Let’s show Congress and the FDA that our self-advocacy movement will not be quieted and that we continue to grow stronger and more determined!

Thank you for campaigning with us,

Anthony Carbajal, Bethany Wolfe, the Torrino Family, Nick Grillo (gm6nick@gmail.com), and Jehad Majed (jmajed@mac.com)

Email the FDA at:
And cc these people:

Here’s what to say:

[Share your personal story or simply explain why you support the ALS Community in our self-advocacy efforts in getting a viable treatment to market. Then include the following]:

On 23 February 2013, The FDA held its first public hearing to address the urgency and disparities faced by the ALS Community. The meeting was standing room only and was also attended by the ALS Association (ALSA) and the Muscular Dystrophy Association (MDA). Following the meeting, these two advocacy organizations sent a joint statement detailing action items that were expected to change the design of future clinical trials and make treatments more readily available to people with ALS (PALS). http://mda.org/alsn/mda-and-alsa-urge-fda-take-action-groundbreaking-als-hearing.

It has been over two years since that joint statement was offered to the FDA and still the ALS Community finds there has been absolutely no change with regards to preclinical development or clinical trial design. Neither has the consideration of benefit-risk assessment been implemented in getting new treatments to patients suffering a horrible death.

Additionally, it is hard to ignore that the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is quite clear in its intent and that FDA is strongly encouraged by Congress to grant Accelerated Approval (AA) to treatments that benefit all serious and life threatening diseases. We see that the FDA has done very little to more itself further in this regard. As Congress is crafting the 21st Century Cures Act, you now have an opportunity to show them that you are on board. GM604 is a perfect fit for the AA Program.

Please approve Genervon’s GM604 so all PALS can have access to this promising new treatment and hope for a future.


New member
How many ALS patients have died in those 2 years? Why should anyone need to beg the government for their life? Shameful is what it is.