The Honorable

Ed Whitfield
2184 Rayburn HOB
Washington, DC 20515-1701
Dear Mr. Whitfield,
My name is Todd Walker. I live at 774 Oaks Country Club Road, Murray,
KY. My home telephone number is (270)-753-8097. I was diagnosed
with ALS (Lou Gehrigs Disease) in August, 2013. I currently cannot
move from the neck down. By the grace of God, I still have the ability
to speak! I would love to continue to do that for His Glory.
I am writing to express interest in the approval status of a bio-drug
produced by Genervon Biopharmaceuticals LLS, known as GM604 or
GM6. This drug was granted a fast track designation for the treatment
of amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease) in 2013
and was also awarded an orphan drug designation by the FDA on
March 3, 2014 for the treatment of ALS.
On January 8th, 2015, Genervon announced that it had submitted
results of its single compassionate patient trial (GALS-C) to the FDA of
drug candidate GM6. Last month (February 2015), representatives
from Genervon met with the FDA to request accelerated approval of
GM6 for all ALS patients. They supplemented their case with evidence
of demonstrated safety, statistically-significant efficacy between
treated and placebo groups in biomarker data.
I fully appreciate the vast importance of the FDAs comprehensive and
thorough approval process, and the role of the agency in protecting
public health. But as one who lives with ALS, I also know the
tremendous hardships this devastating disease places on not only me,
but even more so, on my family!
Therefore, I respectfully request and urge that Genervon be given full
and fair consideration as they discuss the need for accelerated
approval of GM6. GM6 should be advanced to conditional approval in a
post-marketing surveillance program. In their phase 2 trial they
demonstrated safety and waiting for a phase 3 trial will result in certain
death for thousands of ALS patients, including myself. Currently
Riluzole is the only one FDA approved drug for ALS and only increases
the life span of a small number of patients by a few months.
Our best hope is to target the FDA via the Senate H.E.L.P. Committee.
Please use your influence with Committee Chairman Senator Lamar
Alexander, Senator Patty Murray, Ranking Member and KY
Representative Paul Rand by insisting that they convince the FDA to be

flexible so GM6 can reach patients who need it now while also
collecting additional information from patient experiences and ongoing
non-randomized trials that can lead to full approval of the drug. We
patients get access to GM6 while scientists get their data collected
over a longer period of time.
It is urgent that the Senators on the H.E.L.P. Committee help change
the way ALS patients are able to access new drugs and treatments that
could change the course of ALS progression and prognosis. That can
start now with Genervon's GM6.
Thank you for your consideration in urging the FDA to allow for
accelerated approval of GM6. Doing so would mean rescue from ALS
for many tens of thousands stricken with this terrible disease as well as
prevent this disease from striking thousands of others.
Sincerely,
M. Todd Walker (Your fellow republican)