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Dead as a Doornail

Dear FDA Advisory Committee Members,

I’m considered dead. What an image that creates; I’m lying in a morgue with a toe tag. Dead as a doornail, six feet under. I’m deceased by definition in ALS clinical trials. Yet, I can still initiate movement in nearly every voluntary muscle in my body. How can a dead person do that? I have motor neurons that are still alive and telling me to hang on to hope. I am very much alive.

I had tracheostomy surgery in November 2021 to extend my life with the expectation that NurOwn data would be fairly and fully examined, anticipating FDA approval. I’m not a scientist, neurologist, or biostatistician. I do not purport to understand the intricacies of neurofilament light, yet I know biomarkers are a significant step forward in finding a disease-modifying treatment. I have hope for a treatment that could reverse the course of my disease.

I have lived with ALS for over ten years, and I know more about living with ALS than the esteemed Advisory Committee members. I have lived through the loss of every point on the ALSFRS-R from 48 to 8 and am acutely aware of its shortcomings as an accurate measure of abilities or disease progression.

As you review the totality of the evidence, please include the human experience along with the science. The weight of your decision is heavy, with life and death consequences. This is about much more than a primary endpoint. There is real-world evidence that NurOwn helps some. There is biomarker evidence that NurOwn impacts the disease.

I’m a daughter, wife, mom, and grandma. I’m a US Navy Veteran and a dedicated ALS Advocate. I know people who have benefitted from NurOwn’s open label extension and Right to Try. Please see that I, too, am alive and deserving of a chance, backed by evidence, to add precious time to my life. Please, see me.

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That’s the public comment I’ve submitted to the FDA regarding an upcoming Advisory Committee (AdComm) meeting regarding Brainstorm’s NurOwn Therapy. The AdComm will review the clinical evidence presented by Brainstorm. You can read more about the clinical trial data here.

I’m confident that the AdComm panel members are brilliant scientists and medical professionals, but they are not ALS specialists. They may not know ALS is fatal. They may not know about the shortcomings of the ALS functional rating scale. They may not know of ALS’ cruelty and how desperately we need disease-modifying treatments. It’s our job to tell them.

I AM ALS volunteers wrote this guide that explains more about the AdComm meeting, things to consider when writing your comment, and step-by-step instructions for submitting your comment.

This isn’t the place for pitchforks and burning torches. But our stories are essential, and the FDA needs to hear from each of us. Read posted comments here, and submit your comment today.

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