Corrupt @FDACBER @US_FDA has blocked #NurOwn 9 years - Re MOA “We don’t care about that”, then waste hrs at #ShamAdcomm - Used unscrupulous slides to mislead panel - Block Navy Vet who had treatment speak - Ignored Dr Windeback & 1000’s others - Ignored compelling biomarkers

FDA’s own CBER precedent confirms that real-world evidence, external controls, natural history, compassionate-use data, survival, biomarkers, and single-arm/open-label evidence can serve as substantial evidence for approval, especially in serious rare/fatal diseases where conventional trials are ethically and practically limited. Given NurOwn’s established safety profile, clinical findings, biomarker evidence, and the totality of data accumulated over years of study and expanded access, @FDACBER should move urgently to evaluate every available regulatory pathway that could provide patient access NOW while additional evidence continues to be generated. #NurOwn should be approved immediately! @FDA_KyleD @aVoice4ALS @MinoShah @houmanhemmati @PeterPitts @BrainstormCell @iamalsorg

If it’s safe and it works, even for some, it should be approved. This is not difficult. That doesn’t mean the science stops. It means patients get a chance while the evidence continues to grow. In fatal diseases like ALS, Huntingtons, Pancreatic or Glioblastoma Cancer, the ethical question isn’t just whether we might approve too early. It’s whether we’re willing to let patients die waiting for certainty that may never come. When safety is established and meaningful benefit is demonstrated in at least a subset of patients, the answer should be access, not delay. Medicine has evolved. Science has evolved. Patients have evolved. It’s time FDA leadership evolves as well and embraces a modern, ethical framework that recognizes the cost of inaction is measured in human lives. @FDA_KyleD @SecKennedy

"Efficiency" is a cruel joke to those of us with #ALS @MartyMakary, the NurOwn Citizens Petition is 90 days past the FDA deadline. If you won't pressure @VPrasadMDMPH to act, you aren't a reformer—you’re just the latest FDA leader choosing bureaucracy over lives. Stop talking. Start signing. @BillCassidy @RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @SenRonJohnson @ChuckGrassley @FDACBER @SecKennedy @RobertKennedyJr @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis

@Royals George Brett is right. No American should have to travel to China to get #stemcell treatments because @US_FDA has failed to approve one here. @DrMakaryFDA since July 3rd, @CBER has had a Citizens Petition asking you to approve #NurOwn. It contains unprecedented survival data that proves #NurOwnWorks for people like Sarah. ▪︎ 87 months of trach free survival vs 30 months natural history ▪︎ 79% reduction in risk of trach or death ▪︎ 100% in EAP achieved 5 yr survival vs <20% in natural history All this beats survival data of approved #ALS and cancer therapies. Give @SarahNauser @SlangsOnSports & 32k others a chance to watch decades more Opening Days. Grant Accelerated Approval of NurOwn. @SecKennedy said he'd end the war on stem cells. You said you'd marry common sense with gold standard science. This is your chance to change the future of #ALS. Check out Citizens Petition at nurownworks.com. Thx @MLBNetwork for supporting the ALS community. #ENDALS #FightLikeAGirl #MLBCentral #MLBTonight #BaseballTwitter #nurownworks #LouGehrig #LG4day #BaseballisGreat

100% fatal since 1869. Time is the one thing #ALS patients do not have Yet, our NurOwn Citizens Petition sits ignored—now 67 DAYS past the @FDACBER deadline If @DrMakaryFDA is truly changing things, why is he acting just like past FDA leaders? Who else is being neglected? Every FDA Commissioner says that they are better than previous FDA leaders. @BillCassidy @RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @SenRonJohnson @ChuckGrassley @MartyMakary @SecKennedy @RobertKennedyJr @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis

How long must hopeless patients wait for a chance at life? It's been 8 months since we filed the #NurOwn Citizens Petition—well past the FDA's 6-month deadline @FDACBER & @VPrasadMDMPH: We have the evidence for accelerated approval for a 100% fatal disease. Stop the silence. 🛑

.@DrMakaryFDA, I'm dying of #ALS—a 100% fatal sentence since 1869. NurOwn WORKS, but FDA delays are costing lives The facts: 🚨 Unprecedented survival in trials since 2010 🚨 Phase 3 data alone screams for accelerated approval 🚨 Citizen Petition deadline blown by 50 days. How many more must die while you delay? @VPrasadMDMPH @FDACBER

.@DrMakaryFDA @SecKennedy @VPrasadMDMPH @FDACBER, I am a NuOwn Citizens Petitioner dying of ALS. You missed your 12/30/25 deadline to answer. It is now Feb 2026 You've forgotten #ALS & left us to die without hope. UNPRECEDENTED BREAKTHROUGHS EVERY DAY from every country BUT the USA @MartyMakary @RobertKennedyJr, I had hope when I heard your promises, but you're no different. The regulatory flexibility you promised is reserved for Big Pharma. #FDAfailedALS Future generations of terminal Americans have to hope for cures from other countries @realDonaldTrump @RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @RepRichHudson  @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray  @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @DorisMatsui @RepDonBacon @SenJohnCurtis

.@DrMakaryFDA @SecKennedy @VPrasadMDMPH @FDACBER, I am a NuOwn Citizens Petitioner dying of ALS. You missed your 12/30/25 deadline to answer. It is now Feb 2026 You've forgotten #ALS & left us to die without hope. UNPRECEDENTED BREAKTHROUGHS EVERY DAY from every country BUT the USA @MartyMakary @RobertKennedyJr, I had hope when I heard your promises, but you're no different. The regulatory flexibility you promised is reserved for Big Pharma. #FDAfailedALS Future generations of terminal Americans have to hope for cures from other countries @realDonaldTrump @RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @DorisMatsui @RepDonBacon @SenJohnCurtis

The @US_FDA MUST act with the same urgency/flexibility for 100% Fatal ALS as it routinely does for terminal cancer treatments Over 1 million Americans alive today will be diagnosed with 157 year 100% Fatal #ALS, but it's likely more with the expected 40% increase in the next decade. #ALS doesn't care about occupation, socioeconomic status, fame, age, gender, race, religion, or ethnicity. I have been fighting for #Nurown since I was fully independent, but I have realized that people dying of ALS are forgotten at the #FDA. #AcceleratedApproval4NUROWN This is a horrific tragedy, not only for us, but for the families who are getting this death sentence every day. @realDonaldTrump @RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @DrMakaryFDA @SecKennedy @FDACBER @VPrasadMDMPH @MartyMakary @RobertKennedyJr @SenatorCollins @SenatorLujan @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray  @SenatorBaldwin @timkaine @senatorhassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @DorisMatsui @RepDonBacon @SenJohnCurtis

.@DrMakaryFDA @SecKennedy @FDACBER @VPrasadMDMPH, while you tout your accomplishments, nothing has changed in ALS even since the first case was identified in 1869 ZERO CHANCE OF SURVIVAL WITH CURRENT FDA-APPROVED TREATMENTS. #NurOwnWorks @DrOz @DrOzCMS today.com/parents/family/sar…

Everyone with #ALS is dying WITHOUT HOPE, while the @FDACBER delays, 158 DAYS after receiving the #NUROWN Citizens' Petition You or your loved one could be next @SecKennedy @RobertKennedyJr @DrMakaryFDA @MartyMakary @VPrasadMDMPH @POTUS @realDonaldTrump @DrOz @DrOzCMS

.@FDACBER @VPrasadMDMPH @DrMakaryFDA, you brought hope with your words, but did you mean what you said? 138 DAYS you've had our Nurown Citizens petition=SILENCE ALS=100% FATAL since 1869 @SecKennedy, Every day of delay=more HORRIFIC deaths WITHOUT HOPE. No words can convey how HORRIFIC the suffering is while we wait on the FDA GRANT ACCELERATED APPROVAL for NurOwn NOW. Our Citizens' Petition, submitted on July 3rd and now ignored for 138 days, demands it. This autologous stem cell therapy—our own cells engineered to flood our brains with life-saving neurotrophins—is ALS's FIRST BREAKTHROUGH in 156 years of hell. The Phase 3b trial was cleared in May 2025, and the data from the 2022 ADCOMM screams for approval. Irrefutable Evidence Biomarkers PROVE It Works: Reduced Neuroinflammation: Significant decrease in MCP-1 cytokines (p<0.05). Reduced Neurodegeneration: Significant drop in Neurofilament Light Chain (NfL) (p<0.05). Increased Neuroprotection: Massive surge in neuroprotective growth factors like GDNF/VEGF (p≤0.001). A total of 23 signals confirm target engagement. Real-World Survival SHATTERS Norms: The Expanded Access Program (EAP, n=10) shows 100% 5-YEAR survival without tracheostomies, compared to only 20% in the natural history of the disease (p=0.006). The median tracheostomy-free survival is extended to 7 YEARS (a 2-3x extension). Progression was halted for up to 17 months, and 85% of participants saw a SLOWED decline (ALSFRS-R: 0.15 pts/mo vs. natural freefall). Navy veteran Matt Bellina GAINED 6 points on the ALSFRS-R scale after 7 doses. ALS Trials are Rigged Against Hope: Current trials suffer from small sample sizes (n=200), extreme patient heterogeneity, and the flawed ALSFRS-R questionnaire as the primary endpoint. NurOwn has shown success despite these barriers. The TOFERSEN Precedent: Tofersen was approved based on an NfL drop alone for just 2% of the ALS population. NurOwn has demonstrated broader, better survival benefits supported by extensive real-world evidence & ALSO HAD A STATISTICALLY SIGNIFICANT REDUCTION IN Nfl. Accelerated Approval with a Phase 4 follow-up is the clear path forward. A Direct Appeal to FDA Leadership @MartyMakary: You have vowed to combine "gold standard science common sense" to give rare disease warriors faster access. We are asking you to deliver on that promise for cell therapies. @RobertKennedyJr: Your crusade for stem cell therapies and your goal to end the FDA's "war" on them directly targets the crisis facing veterans and the underserved who are massacred by ALS. Thousands are dying during these delays. Fulfill your promise. Bureaucracy KILLS. Evidence SAVES. Read the petition: nurownworks.com/read-the-pet… Convene a meeting TODAY. Give us a fighting chance to LIVE. #BeyondSignsOfPromise #ApproveNurOwn #EndALS156YearsOfHopelessness @realDonaldTrump @POTUS @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @DrOz @DrOzCMS @GovBraun @BernieSanders @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @BillCassidy

.@DrMakaryFDA @FDACBER @SecKennedy, we MUST remember those who have died/are dying/will die from HORRIFIC 100% FATAL MILITARY SERVICE-RELATED #ALS Navy vet Matt Bellina, ALSFRS-R 21, wheelchair-bound, choked eating, needed BiPAP. After 7 NurOwn doses via Right to Try: 6 pts to 27, stood unassisted (arms-free after 2 yrs), no choking, breathed independently, speech/swallow improved, lung capacity 23%, core/arm strength up! Despite these UNPRECEDENTED benefits, @BellinaMatthew & ALL with ALS have been left to die. @BrainstormCell @Cylebo MUST meet @MartyMakary @VPrasadMDMPH about Accelerated Approval of SAFE & EFFECTIVE #NurOwn We MUST STOP CONDEMNING these heroes to die WITHOUT HOPE. While we delay, veterans are dying. 1 in 6 ALS deaths are veterans – this alone deserves URGENT ACTION from Congress We cannot stand idly while those who served our country are abandoned by the very system meant to protect them. I urge the new @US_FDA leadership to grant #Nurown the Commissioner's National Priority Voucher Program #CNPV Honor our veterans' sacrifices by fighting for their right to life. Veteran organizations & currently healthy veterans MUST join the fight to END MILITARY SERVICE RELATED #ALS. Veterans have a 2X to 10X ⬆️ ALS risk depending on military occupation For veterans with HORRIFIC #ALS today & the MANY who will be diagnosed, we MUST END the CRUEL @FDACBER regulatory RIGIDITY for 100% FATAL #ALS Veterans' voices are among the most powerful in this fight. We MUST END 156 years of hopelessness that disproportionately affects military veterans. HOW MANY MORE HAVE TO BURY LOVED ONES before 100% FATAL ALS (since 1st identified in 1869) is treated with the same URGENCY & regulatory flexibility as cancer treatments? @realDonaldTrump @POTUS @RobertKennedyJr @HASCRepublicans @HASCDemocrats @SASCGOP @SASCDems @HouseVetAffairs @VetAffairsDemson @SVACGOP @SVACDems @BipartisanVets @RepAndyHarrisMD @RepDonBacon @SenatorWicker @DrNealDunnFL2 @RepDanCrenshaw @RepMMM @RepJames @RepGuthrie @RepJackBergman @RepVanOrden @RepKiggans @RepAbeHamadeh @VernBuchanan @SenJimBanks @RogerMarshallMD @sentuberville

.@FDACBER @VPrasadMDMPH, 132 DAYS you've had our Nurown Citizens petition=SILENCE Laura Jean is one of tens of 1000s who have #DiedWaiting WITHOUT HOPE leaving behind her husband & 3 young children @SecKennedy @DrMakaryFDA, Every day of delay=more HORRIFIC deaths. No words can convey how HORRIFIC the suffering is while we wait on the FDA You're MISTAKEN if you believe 100% FATAL #ALS can't happen to YOU. GRANT ACCELERATED APPROVAL for NurOwn NOW. Our Citizens' Petition, submitted on July 3rd and now ignored for 127 days, demands it. This autologous stem cell therapy—our own cells engineered to flood our brains with life-saving neurotrophins—is ALS's FIRST BREAKTHROUGH in 156 years of hell. The Phase 3b trial was cleared in May 2025, and the data from the 2022 ADCOMM screams for approval. Irrefutable Evidence Biomarkers PROVE It Works: Reduced Neuroinflammation: Significant decrease in MCP-1 cytokines (p<0.05). Reduced Neurodegeneration: Significant drop in Neurofilament Light Chain (NfL) (p<0.05). Increased Neuroprotection: Massive surge in neuroprotective growth factors like GDNF/VEGF (p≤0.001). A total of 23 signals confirm target engagement. Real-World Survival SHATTERS Norms: The Expanded Access Program (EAP, n=10) shows 100% 5-YEAR survival without tracheostomies, compared to only 20% in the natural history of the disease (p=0.006). The median tracheostomy-free survival is extended to 7 YEARS (a 2-3x extension). Progression was halted for up to 17 months, and 85% of participants saw a SLOWED decline (ALSFRS-R: 0.15 pts/mo vs. natural freefall). Navy veteran Matt Bellina GAINED 6 points on the ALSFRS-R scale after 7 doses. ALS Trials are Rigged Against Hope: Current trials suffer from small sample sizes (n=200), extreme patient heterogeneity, and the flawed ALSFRS-R questionnaire primary endpoint. NurOwn has shown success despite these barriers. The TOFERSEN Precedent: Tofersen was approved based on an NfL drop alone for just 2% of the ALS population. NurOwn has demonstrated broader, better survival benefits supported by extensive real-world evidence & ALSO HAD A STATISTICALLY SIGNIFICANT REDUCTION in Nfl. A conditional approval with a Phase 4 follow-up is the clear path forward. A Direct Appeal to FDA Leadership @MartyMakary: You have vowed to combine "gold standard science common sense" to give rare disease warriors faster access. We are asking you to deliver on that promise for cell therapies. @RobertKennedyJr: Your crusade for stem cell therapies and your goal to end the FDA's "war" on them directly targets the crisis facing veterans and the underserved who are massacred by ALS. Thousands are dying during these delays. Fulfill your promise. Bureaucracy KILLS. Evidence SAVES. Read the petition: nurownworks.com/read-the-pet… Convene a meeting TODAY. Give us a fighting chance to LIVE. #BeyondSignsOfPromise #ApproveNurOwn #EndALS156YearsOfHopelessness @realDonaldTrump @POTUS @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @DrOz @DrOzCMS @GovBraun @BernieSanders @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @BillCassidy

.@FDACBER @VPrasadMDMPH, you brought hope with your words, but did you mean what you said? 127 DAYS you've had our Nurown Citizens petition=SILENCE ALS=100% FATAL since 1869 @SecKennedy @DrMakaryFDA, Every day of delay=more HORRIFIC deaths WITHOUT HOPE. No words can convey how HORRIFIC the suffering is while we wait on the FDA GRANT ACCELERATED APPROVAL for NurOwn NOW. Our Citizens' Petition, submitted on July 3rd and now ignored for 127 days, demands it. This autologous stem cell therapy—our own cells engineered to flood our brains with life-saving neurotrophins—is ALS's FIRST BREAKTHROUGH in 156 years of hell. The Phase 3b trial was cleared in May 2025, and the data from the 2022 ADCOMM screams for approval. Irrefutable Evidence Biomarkers PROVE It Works: Reduced Neuroinflammation: Significant decrease in MCP-1 cytokines (p<0.05). Reduced Neurodegeneration: Significant drop in Neurofilament Light Chain (NfL) (p<0.05). Increased Neuroprotection: Massive surge in neuroprotective growth factors like GDNF/VEGF (p≤0.001). A total of 23 signals confirm target engagement. Real-World Survival SHATTERS Norms: The Expanded Access Program (EAP, n=10) shows 100% 5-YEAR survival without tracheostomies, compared to only 20% in the natural history of the disease (p=0.006). The median tracheostomy-free survival is extended to 7 YEARS (a 2-3x extension). Progression was halted for up to 17 months, and 85% of participants saw a SLOWED decline (ALSFRS-R: 0.15 pts/mo vs. natural freefall). Navy veteran Matt Bellina GAINED 6 points on the ALSFRS-R scale after 7 doses. ALS Trials are Rigged Against Hope: Current trials suffer from small sample sizes (n=200), extreme patient heterogeneity, and the flawed ALSFRS-R questionnaire primary endpoint. NurOwn has shown success despite these barriers. The TOFERSEN Precedent: Tofersen was approved based on an NfL drop alone for just 2% of the ALS population. NurOwn has demonstrated broader, better survival benefits supported by extensive real-world evidence & ALSO HAD A STATISTICALLY SIGNIFICANT REDUCTION in Nfl. A conditional approval with a Phase 4 follow-up is the clear path forward. A Direct Appeal to FDA Leadership @MartyMakary: You have vowed to combine "gold standard science common sense" to give rare disease warriors faster access. We are asking you to deliver on that promise for cell therapies. @RobertKennedyJr: Your crusade for stem cell therapies and your goal to end the FDA's "war" on them directly targets the crisis facing veterans and the underserved who are massacred by ALS. Thousands are dying during these delays. Fulfill your promise. Bureaucracy KILLS. Evidence SAVES. Read the petition: nurownworks.com/read-the-pet… Convene a meeting TODAY. Give us a fighting chance to LIVE. #BeyondSignsOfPromise #ApproveNurOwn #EndALS156YearsOfHopelessness @realDonaldTrump @POTUS @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @DrOz @DrOzCMS @GovBraun @BernieSanders @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @BillCassidy

.@DrMakaryFDA @SecKennedy @FDACBER @VPrasadMDMPH, ALS is a 100% FATAL MILITARY SERVICE-RELATED DISEASE 1 of every 6 deaths are veterans 118 DAYS you've had our Nurown Citizens petition= SILENCE Veterans organizations MUST meet with Congress & the @US_FDA to DEMAND: ➡️ Prioritize #ALS. ➡️ Give ALS treatments the SAME URGENCY & FLEXIBILITY as cancer treatments Why? ▪️ ALS has been 100% FATAL since 1869. ▪️ 1 out of 6 who die are VETERANS. ▪️ #ALS IS NOT RARE. Incidence is rising, but patients die quickly. Veterans' voices are powerful. We MUST END 156 years of hopelessness that disproportionately affects our heroes. @realDonaldTrump, are you OK with your #US_FDA dragging its feet while so many veterans die? @POTUS @RobertKennedyJr @MartyMakary @iava @ConcernedVets @BlueStarFamily @ReturnVeterans @military_family @vetshelpingvets @stand4heroes @MilitaryTimes @Op_Homefront @LukesWingsUSA @usvetsnational @DeptVetAffairs @veteransunited @VeteransOnDuty @MVadvocacy @DAVHQ @AMVETSHQ @VeteransHealth @commondefense @OperationCandC @atlasveteransca @wehonorveterans @soldiersangels @usvetsnational @AMVETSHQ @VUFoundation @HonorInstitute @CarryTheLoad @ComcastMilitary @TeamRWB @homebaseprogram @AmericanLegion @RepDonBacon @RepAndyHarrisMD

.@FDACBER @SecKennedy @DrMakaryFDA, 113 DAYS you've had our Nurown Citizens petition=SILENCE Nothing more difficult than ALS appts when you see progression even when there is almost nothing left. NO HOPE WHILE THE #FDA DRAGS ITS FEET It doesn't seem like #FDA leadership is following up on their promises with action for #ALS. It is tough to see any hope for a disease where we're all SCREAMING, but there is no sound 113 DAYS you've had our Nurown Citizens petition=SILENCE. @VPrasadMDMPH ALS=100% FATAL since 1869 Every day of delay=more HORRIFIC deaths WITHOUT HOPE. No words can convey how HORRIFIC the suffering is while we wait on the FDA GRANT ACCELERATED APPROVAL for NurOwn NOW. Our Citizens' Petition, submitted on July 3rd and now ignored for 113 days, demands it. This autologous stem cell therapy—our own cells engineered to flood our brains with life-saving neurotrophins—is ALS's FIRST BREAKTHROUGH in 156 years of hell. The Phase 3b trial was cleared in May 2025, and the data from the 2022 ADCOMM screams for approval. Irrefutable Evidence Biomarkers PROVE It Works: Reduced Neuroinflammation: Significant decrease in MCP-1 cytokines (p<0.05). Reduced Neurodegeneration: Significant drop in Neurofilament Light Chain (NfL) (p<0.05). Increased Neuroprotection: Massive surge in neuroprotective growth factors like GDNF/VEGF (p≤0.001). A total of 23 signals confirm target engagement. Real-World Survival SHATTERS Norms: The Expanded Access Program (EAP, n=10) shows 100% 5-YEAR survival without tracheostomies, compared to only 20% in the natural history of the disease (p=0.006). The median tracheostomy-free survival is extended to 7 YEARS (a 2-3x extension). Progression was halted for up to 17 months, and 85% of participants saw a SLOWED decline (ALSFRS-R: 0.15 pts/mo vs. natural freefall). Navy veteran Matt Bellina GAINED 6 points on the ALSFRS-R scale after 7 doses. The Case for Approval ALS Trials are Rigged Against Hope: Current trials suffer from small sample sizes (n=200), extreme patient heterogeneity, and the flawed ALSFRS-R questionnaire as the primary endpoint. NurOwn has shown success despite these barriers. The TOFERSEN Precedent: Tofersen was approved based on an NfL drop alone for just 2% of the ALS population. NurOwn has demonstrated broader, better survival benefits supported by extensive real-world evidence & ALSO HAD A STATISTICALLY SIGNIFICANT REDUCTION in Nfl IN THE PHASE 3 TRIAL. Accelerated Approval with a Phase 4 follow-up is the clear path forward. A Direct Appeal to FDA Leadership @MartyMakary: You have vowed to combine "gold standard science common sense" to give rare disease warriors faster access. We are asking you to deliver on that promise for cell therapies. @RobertKennedyJr: Your crusade for stem cell therapies and your goal to end the FDA's "war" on them directly targets the crisis facing veterans and the underserved who are massacred by ALS. Thousands are dying during these delays. Fulfill your promise. Bureaucracy KILLS. Evidence SAVES. Read the petition: nurownworks.com/read-the-pet… Convene a meeting TODAY. Give us a fighting chance to LIVE. #BeyondSignsOfPromise #ApproveNurOwn #EndALS156Year @realDonaldTrump @POTUS @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @DrOz @DrOzCMS @GovBraun @BernieSanders @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @BillCassidy

.@FDACBER @SecKennedy @DrMakaryFDA, We're still fighting for our lives. It doesn't seem like #FDA leadership is following up on their promises with action for #ALS. It is tough to see any hope for a disease where we're all SCREAMING, but there is no sound 106 DAYS you've had our Nurown Citizens petition=SILENCE. @VPrasadMDMPH ALS=100% FATAL since 1869 Every day of delay=more HORRIFIC deaths WITHOUT HOPE. No words can convey how HORRIFIC the suffering is while we wait on the FDA GRANT ACCELERATED APPROVAL for NurOwn NOW. Our Citizens' Petition, submitted on July 3rd and now ignored for 99 days, demands it. This autologous stem cell therapy—our own cells engineered to flood our brains with life-saving neurotrophins—is ALS's FIRST BREAKTHROUGH in 156 years of hell. The Phase 3b trial was cleared in May 2025, and the data from the 2022 ADCOMM screams for approval. Irrefutable Evidence Biomarkers PROVE It Works: Reduced Neuroinflammation: Significant decrease in MCP-1 cytokines (p<0.05). Reduced Neurodegeneration: Significant drop in Neurofilament Light Chain (NfL) (p<0.05). Increased Neuroprotection: Massive surge in neuroprotective growth factors like GDNF/VEGF (p≤0.001). A total of 23 signals confirm target engagement. Real-World Survival SHATTERS Norms: The Expanded Access Program (EAP, n=10) shows 100% 5-YEAR survival without tracheostomies, compared to only 20% in the natural history of the disease (p=0.006). The median tracheostomy-free survival is extended to 7 YEARS (a 2-3x extension). Progression was halted for up to 17 months, and 85% of participants saw a SLOWED decline (ALSFRS-R: 0.15 pts/mo vs. natural freefall). Navy veteran Matt Bellina GAINED 6 points on the ALSFRS-R scale after 7 doses. The Case for Approval ALS Trials are Rigged Against Hope: Current trials suffer from small sample sizes (n=200), extreme patient heterogeneity, and the flawed ALSFRS-R questionnaire as the primary endpoint. NurOwn has shown success despite these barriers. The TOFERSEN Precedent: Tofersen was approved based on an NfL drop alone for just 2% of the ALS population. NurOwn has demonstrated broader, better survival benefits supported by extensive real-world evidence & ALSO HAD A STATISTICALLY SIGNIFICANT REDUCTION in Nfl IN THE PHASE 3 TRIAL. Accelerated Approval with a Phase 4 follow-up is the clear path forward. A Direct Appeal to FDA Leadership @MartyMakary: You have vowed to combine "gold standard science common sense" to give rare disease warriors faster access. We are asking you to deliver on that promise for cell therapies. @RobertKennedyJr: Your crusade for stem cell therapies and your goal to end the FDA's "war" on them directly targets the crisis facing veterans and the underserved who are massacred by ALS. Thousands are dying during these delays. Fulfill your promise. Bureaucracy KILLS. Evidence SAVES. Read the petition: nurownworks.com/read-the-pet… Convene a meeting TODAY. Give us a fighting chance to LIVE. #BeyondSignsOfPromise #ApproveNurOwn #EndALS156Year @realDonaldTrump @POTUS @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @DrOz @DrOzCMS @GovBraun @BernieSanders @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @BillCassidy

#ALS can strike ANYONE at ANY age, ethnicity, socioeconomic status, religion, gender, profession, etc Venture capitalist CEO & founder of @OurCrowd, @jonmedved steps down duo to #ALS diagnosis I hope he knows that the greatest hope for ALS today is a company founded in Israel called @BrainstormCell by the late, world-renowned physician scientist, Dr. Eldad Melamed. @Cylebo @MaryKayTurner1 calcalistech.com/ctechnews/a…