ALT Brian was in the NurOwn Phase 3 trial. He flew back & forth 14x from Virginia to Southern California to participate in the trial. Unlike cancer trials, the FDA makes ALS trials have placebos. The NurOwn trial had a 50-50 placebo. Sadly, this 38 yr old Dad believes he was in the Placebo arm. But he had hope as he was one of a few chosen to participate in the small Expanded Access program. But once again, FDA's conduct halted that as well. When the FDA made an illegal & defamatory statement about the trial, the company halted the Expanded Access program. At that time, Brian was still able to use his hands, still able to speak & breathe, & still working for our US govt. Brian's condition today is attributable to the FDA. Their illegal statement deprived Brian of receiving NurOwn after he sacrificed so much to participate in the trial. Then their failure to approve NurOwn is a Type II error. Brian was right when he said the FDA was protecting him to death.

ALT Trevor's 1st symptoms were in Sept 2017. He had cramping in his L hand & in his calves. He has a lot of spasticity & clonus. He tried to catch a ball or shoot a basketball... felt clumsy. His wife is a pediatrician. He told her that he needed a neuro appt. Trevor had his EMG & was dx'd with ALS in Nov 2017. He saw UCSF in Feb 2018 who confirmed ALS. In July 2018, he could see twitching in his neck. In 2019, struggling to walk when he tripped & fell in the driveway. In 2020, he was in the NurOwn Phase 3 trial at Cedars-Sinai. Within a few days, his twitching, morning muscle spasms & clonus stopped for 1st time in 2 years. Drooling decreased. His leg strength improved & he was able to walk during PT. His massage therapist reported that the spasticity in his muscles "almost feel normal." She witnessed him able to open his hands flat again, which he had never done. He was able to write again as well.

ALT ALS is a 100% fatal & paralyzing disease with no disease-modifying treatments. NurOwn has slowed or halted their progression. Some even regained function. They know NurOwn Works and has been working since the Phase 2 trial in 2015. Appx 6,000 people die of ALS each year. We have allowed over 42,000 Americans to die while this autologous mesenchymal stem cell therapy was working in some. In a 100% fatal disease, some is enough. 🔹Phase 2 - Mike Cimbura (deceased), Bobby Forster, Terri Pickering Saenz 🔹EAP & Phase 3 - Sandy Morris (deceased), Phil Green, Eric Stevens, Josh Smith, Matt Klingenberg, Roberto Muggli 🔹Phase 3 - Betsy McCormick, Thurman Maynard, Kade Simons 🔹Right to Try - Navy Pilot Matt Bellina We cannot continue sacrifice human lives at the altar of Type II errors. Failing to approve NurOwn resulted in IRREPARABLE HARM, just as much as a Type I error of approving an unsafe drug.