UPDATE: I AM ALS delivers petition signed by 30,000 to FDA’s Dr. Peter Marks

March 9, 2023:

On December 14th, 2022, I AM ALS delivered a petition with over 30,000 signatures and supported by twenty ALS organizations. This petition requested that the FDA provide BrainStorm and the ALS community with a public hearing, or Advisory Committee, on NurOwn.

It is now a brand-new calendar year. It is now 85 days since we hand delivered the petition to the FDA on a cold winter day. It is now almost spring.

Thousands of people living with ALS hope the agency does the right thing and allows an independent review of this potential ALS treatment. Time is a luxury that people with ALS simply do not have. As these 85 days have passed, members of our community have died. Too many. Thousands of more people living with ALS have seen their motor skills and functionality decline. Ten of thousands of their loved ones try their best to slow down and lessen the pain of this 100% fatal disease. Time is something that the ALS community does not have.

We are asking you to please act now. Please allow NurOwn a transparent and informative Advisory Committee meeting.

December 14, 2022:

From the desk of Dan Tate, I AM ALS board member, person living with ALS:

Today, we delivered a petition of over 30,000 signatories to Dr. Peter Marks at the FDA! That is an amazing accomplishment even for a community of remarkable people. Sonya Elling presented the case on behalf of I AM ALS for a full and transparent debate over NurOwn. Everyone should be proud of our Chief Government Relations Officer, because she did a great job.

I had the honor of representing pALS. I’ve met Dr. Marks before and know he has deep empathy for our community. He does not shy away, as some others do, from connecting with us and our families. My role was to make clear that we appreciate his personal commitment, BUT CBER, as a whole, does not have the same credibility. Institutions are made up of individuals and somewhere there is a profound disconnect. CBER is not seen as exercising any of the 2019 Guidance for Regulatory Flexibility, and this is a massive problem when our people die every month. Finally, I made it clear that the community would not give FDA the benefit of the doubt unless we had a full and transparent discussion and felt like the community’s voice is heard in the deliberations.

My mother closed the meeting appropriately. She wasn’t planning to say anything, but piped in on behalf of families saying ALS takes an awful toll on everyone. “It’s Dan’s birthday and we want to see more with him.”  It plainly moved Peter Marks.

Of course, Dr. Marks wouldn’t divulge what was going to happen, because that would be wholly inappropriate in a regulatory proceeding. He did however give us time and listened intently to us. He even acknowledged that he “heard” our message. Now, we will see what happens!

Sincerely,
Dan Tate

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So, what are the next steps? Like most campaigns, this is just one step in the effort to produce change. On December 12, 2022, BrainStorm publicly shared that they had submitted a Type A Meeting Request to the U.S. Food and Drug Administration (FDA) to discuss in greater detail the FDA’s refusal to file letter regarding BrainStorm’s Biologics License Application (BLA) for NurOwn. According to Brainstorm’s public statement, during their Type A meeting with the FDA they plan to request a public hearing, in the form of an Advisory Committee Meeting, to discuss NurOwn. The Type A Meeting is expected to occur within 30 days of the FDA’s receipt of the meeting request.

An Advisory Committee Meeting, or AdComm, is a tool used by the FDA to gather input on therapies (medicine and treatments) from independent professionals, impacted communities, and other key stakeholders. Their opinions are non-binding, but are another datapoint that the FDA considers when making decisions.

Right now, we are waiting to hear when the Type A Meeting will occur between the FDA and Brainstorm and what the results of the conversation are. With this information, we will have a better understanding of the FDA rationale and can move forward based on that information.