I am an ALS (Amyotrophic Lateral Sclerosis) patient, fighting a battle every day, with every breath I take. My hope lies in the promise of a drug in development: NurOwn. It is disheartening to see the FDA's handling of this potential life-changing treatment for ALS.

NurOwn is a cell therapy that transforms stem cells into neuron-supporting cells. While the FDA has granted NurOwn a 'Fast Track' status, the progress is anything but swift. According to the Phase II trial results, NurOwn resulted in statistically significant improvements for ALS patients (Source: BrainStorm Cell Therapeutics). Despite promising results, the FDA has not yet approved NurOwn. 

Phase 3 did fail to meets its very aspiirational pre-specified endpoints, but parts of the trial could not be completed due to natinwide Covid 19 travel restrictions. However, multiple trial participants realized substantial improvement, including improved respiration, slowing or halting of disease progression, regaining lost function, and more. One male trialee was able was able to return to work, FULL TIME!

The FDA has codified authority to use regulatory flexibility in their approval proces, but has NOT done so for NurOwn. They HAVE done so for other ALS therapies with weaker data. The FDA acknowdges that some patients did experience very impressive results, but not enough to justify approval. These impressive results have never been seen in any ALS therapy, ever. In fact, ALS has eluded doctors, scientists since it was first documented 155 years ago. The FDA is not utilizing regulatory flexibility consistently. 

The current situation underscores the need for a thorough investigation into the FDA's handling of NurOwn. Doing so would provide transparency and potentially speed up the process, providing desperate patients like myself a fighting chance. 

This isn't just about me or my struggle, it's about the approximately 5,000-6,000 people diagnosed with ALS each year in the U.S. alone, and this is increasing. Every delay in the release of an effective treatment is a delay in our hope for a better quality of life and survival. 

Please sign this petition to urge an investigation into the FDA’s handling of NurOwn.