Petition update

Tell the FDA Compassionate Use and Single Patient IND are not reasonable options for an entire population of terminally ill patients with no viable treatment options

Nicholas Grillo
San Francisco, CA, United States

Apr 4, 2015 — Dear Petitioners:

First, be sure to sign a White House petition. It requires email verification after you sign. Follow the instructions carefully:
https://petitions.whitehouse.gov/petition/request-fda-grant-accelerated-approval-potentially-life-saving-treatments-als-now-starting-gm604

Now the news this week on the FDA:
Recently, Karen Meister, Supervisory Congressional Affairs Specialist at the FDA, sent a letter to Senator Mark Warner (D-VA) saying “there are certain avenues a patient could pursue” to obtain GM604 in the future. In this letter, she appears to suggest that participating in clinical trials, and applying for Compassionate Use and other Expanded Access Programs are reasonable options for the entire ALS population (link below). Tell the FDA that these programs cannot accommodate the enormous number of patients seeking access to GM604. Accelerated Approval is the only reasonable response.
Link to letter from K. Meister: https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxhYXA0Z202fGd4OjNmY2QzN2Q2M2U1NmRlMDQ

We’re in this together,
Anthony Carbajal, Bethany Wolfe, the Torrino Family, Nick Grillo (gm6nick@gmail.com), and Jehad Majed (jmajed@mac.com)

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


Here’s what to say:
[Share your personal story or just mention that you are a supporter of the ALS Community. Then include the following]

Today, I am contacting the FDA to urge Accelerated Approval with post-marketing requirements of Genervon’s GM604 for patients with ALS (PALS). The very powerful organizations that have been responsible in the past for advocating on behalf of the ALS community have failed through nothing less than lack of effort to ensure that treatment options are made available to PALS. The efforts of individuals like Steve Gleason and Pete Frates highlight this failure and has led to the self-advocacy movement that is now evolving.

Fueling the frustration and anger over the FDA’s inability to fully understand the situation, we now read a, letter from Karen G. Meister, FDA Supervisory Congressional Affairs Specialist, to Senator Mark Warner. In this letter, Ms. Meister shifts the responsibility of making GM604 available to patients by suggesting that patients seeking access should pursue the clinical trial process and other legal methods of expanded access such as compassionate exemption and single patient IND. The very reason for the uproar in the ALS Community calling for Accelerated Approval of GM604 is that it is completely unrealistic for any manufacturer to provide treatment to an entire population of people with ALS utilizing these programs. https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxhYXA0Z202fGd4OjNmY2QzN2Q2M2U1NmRlMDQ

Bottom line, an urgent and unmet need for a viable ALS treatment exists and Accelerated Approval is the only reasonable way to address the overwhelming call for access to GM604.

I ask you, “If not GM604, then what other treatment will the FDA get behind?” The truth is there is nothing else in the pipeline that has demonstrated this level of safety and efficacy. I along with the majority of ALS patients identify GM604 as the treatment that appears most promising at this time.


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