Thank You For Taking The Time To Learn About Amyotrophic Lateral Sclerosis (ALS)

Greetings fellow human-beings,

My name is Dan Shultes, I am 42 years old. I am one of 30,000 Americans, that have ALS (Amyotrophic Lateral Sclerosis). It is also known as a motor neurone disease (MND) or Lou Gehrig’s disease.

Many of you may have first heard about ALS, from the viral Ice Bucket Challenge during 2014. The idea behind the challenge was for everyone to experience the cold muscle stiffness that sufferers live with on a daily basis. Supporters ended up raising over $115 million for ALS research.  However, to this day, many people still aren’t aware about the devastating symptoms and life expectancy of this terrible disease.

Stephen Hawkings was diagnosed with ALS when he was just 21. At that time he was given only two years to live. Like many ALS sufferers Stephen was unable to carryout daily activities: such as getting up out of bed,  getting dressed, brushing his teeth, feeding himself, or signing his name. He required constant assistance from those around him. Stephen beat all the odds and lived an additional 55 years. However, the prognosis for most people diagnosed with ALS is a short life-span of 2-4 years.

My goal (with the help of my family and friends), is to create awareness about ALS. The AddressALS website outlines actions that we can all take to help address the issues faced by ALS sufferers.

With your help, we can make a difference.

I thank you with all my heart,

Dan Shultes,

(Husband, Father, Son, Brother, Geothermal Expert & ALS sufferer).

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I have an aggressive form of the disease called Bulbar ALS. I started to exhibit symptoms of ALS back in November 2018. It took over 6 months to diagnose me with the disease. In that short space of time, I lost the ability to talk, to walk by myself, to undertake daily tasks, such as getting out of bed in the morning, or brushing my teeth. Simple daily tasks, that we take for granted are impossible for me now.

HOW TO HELP – Thank you for taking the time to read this. We please ask, if you could, to take five minutes from your day, in support of Dan and the rest of the pALS suffering with this debilitating disease by contacting your local representatives.

 It’s easy to help, it just takes a few easy steps to make a difference:

1) Locate your local representatives (2 senators, 1 congressman)

Click the button below to find your representative.

OR send a text message with the word “Resist” to 50409 on your cell-phone. Use the guidance of the ‘ResistBot’, – it’s a very nifty way of finding your local representatives and sending a message.
(You may also find “ResistBot” via Facebook messenger).

OR you may also visit the ‘Fans of Dan’ Facebook page, to copy and paste the letter for sending.

FOR MEMBERS OF CONGRESS

Currently, there are no clinically meaningful treatments approved by that the FDA that can reverse or stop the symptoms of ALS. Life expectancy for an ALS sufferer is  2-4 years.

The FDA has been working on an ALS Guidance Document since 2013.

In 2018, the FDA issued a draft guidance that offered no innovation in the development of therapies for ALS. During the open public comment period, over 1400 comments were made – all opposed to the draft guidance as issues.

There have been at least 5 meetings between ALS advocates and the FDA, discussing this document and asking for it to be released. It was promised to be completed by June and that deadline was missed again.

In an Advocate meeting in June, Janet Woodcock, M.D. stated that the FDA was short-staffed and that is the reason they had not completed the document. Without this document, clinical trials for ALS will remain inhumane, employing placebo controls. Our first request is to that you contact the FDA and demand the release of the ALS Therapy Guidance Document.

To read the current guidance document being distributed (for comment purposes only). Download the pdf. document file: 17069dft located at the bottom of this section. For questions relating to this draft document contact Billy Dunn at 301-796-2250.

The second urgent issue that requires resolving is the current FDA system, that addresses Drug development.

There is no system in place to address the urgent medical need of an always fatal disease like ALS.

There are some revolutionary, yet promising stem-cell treatments out there. However, they are still in the drug testing phase. One of those therapies is NurOwn®. It is being developed by BrainStorm Cell Therapeutics.

This gained Fast track approval in 2014. It is now in the middle of an archaic Phase 3 trial for 200 patients that is placebo-controlled. 100 patients are made to undergo a procedure called a bone marrow transplant, 7 lumbar punctures and 14 trips for the study to receive a placebo while dying from ALS.

This is simply inhumane.

This is the 4th trial for this therapy and it is showing promising results.  The FDA has been asked to use accelerated approval to approve it immediately. We  also requested an interim analysis of the current phase 3 trial.  They stated that BrainStorm must request the analysis and take a penalty if it is not successful. This could jeopardize the whole trial.

The FDA has been asked to consider expediting the current trial  process. Thus far, all have been denied.

We request you ask the FDA to waive the penalty for the interim analysis and/or complete enrollment in the trial with the number of patients enrolled now.

We ask that you reach out to BrainStorm Cell Therapeutics, to encourage them to go to the FDA, to work together to expedite this promising therapy, for those of us who do not have time to wait during this bureaucratic process.

 

CONTACT BRAINSTORM CELL THERAPEUTICS

Corporate Headquarters
1325 Avenue of Americas, 28th Floor
New York City, NY 10019
Phone: +1-201-488-0460

Thank you for your valuable efforts. Time is not on our side, we need your help today.