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Secretary Kennedy Dr. Marty Makary Vinay Prasad MD MPH I challenge you to spend 24 hours as advanced ALS patient. Show you care about ALS. Retweet if you would like to see this happen. Shah Minokadeh, M.D. Rain Consulting Group No More Excuses ALS Watchdogs! Vita Kalinsky Racing for ALS Bradford G Smith (Brad)

1/12 Dr. Marty Makary Secretary Kennedy FDA Biologics, As one of the (cell therapy) NurOwn Citizens' Petitioners fighting for my life—and the lives of tens of thousands with 100% fatal #ALS—I'm terrified For 156 years, this disease has killed everyone with ZERO treatments providing any hope of

2/12 NurOwn showed REAL signs of promise in the Phase 3 trial (randomized, placebo-controlled). Despite missing the known deeply flowed 12-point questionnaire primary endpoint overall (due to heterogeneity, floor effects, high placebo response), multiple signals emerged:

3/12 *Phase 3 Trial Signs of Promise:* - Statistically significant increases in neurotrophic factors (e.g., VEGF) & reductions in neuroinflammatory/neurodegenerative biomarkers (e.g., MCP-1; robust changes only in NurOwn arm). - 23 of 45 pre-specified CSF biomarkers with

4/12 *Phase 3 Trial Signs of Promise (cont.):* - Statistically significant NfL reduction (~9.4-11% delta vs. placebo in adjusted models; p=0.037; linked to slower decline—same surrogate that got tofersen accelerated approval). - In pre-specified less-advanced subgroup

5/12 *Phase 3 Trial Signs of Promise (cont.):* - Post-hoc analyses (accounting for floor effects/advanced patients): Significant slowing of functional decline on ALSFRS-R. - Independent Harvard/Dana-Farber stats (Lee-Jen Wei): Supportive p-values (0.045, 0.021, 0.007, 0.005)

6/12 *Citizens' Petition Signs of Promise (new EAP/long-term RWE, real-world evidence):* - Unprecedented survival: 100% 5-year survival from symptom onset in EAP cohort (n=10) vs. ~20% natural history (p~0.000335) - Median tracheostomy-free survival ~7 years (range 5-8.5)

7/12 *Citizens' Petition Signs of Promise (cont.):* - Extended progression-free survival: Up to 17 months (or more) during/after treatment—far beyond expected. - Up to 85% slowing of progression (from ≥1 ALSFRS-R point/month loss to ~0.15 points/month post-NurOwn). - Greater

8/12 *Citizens' Petition Signs of Promise (cont.):* - Real-world participant benefits: Many regained motor function, maintained respiratory independence years longer than expected; restored/improved breathing (e.g., reduced need for support); Stabilized/improved forced vital

9/12 •Citizens' Petition Signs of Promise (cont.):* - Respiratory gains: 5-8 year delay in non-invasive ventilation need; halting progression in breathing-critical domain (biggest survival predictor). This is the "totality of evidence" the FDA has NEVER fully reviewed under

10/12 Dr. Marty Makary Marty Makary MD, MPH Marty, I had no idea when we took this photo years ago at Johns Hopkins that you’d one day hold my life—& the lives of tens of thousands with ALS—in your hands as FDA Commissioner. I want to believe you’ll do the right thing. Your confirmation

11/12 ...when senators Murkowski & Collins asked you about using Accelerated Approval for ALS patients facing a “very, very limited time frame” with “no hope of survival,” you committed to flexible pathways, common-sense reforms, and rare disease urgency. That’s exactly

12/12 U.S. FDA FDA Biologics Secretary Kennedy Dr. Marty Makary @VPrasadMDPH: Please don't let this be another broken promise. Grant accelerated approval for NurOwn NOW—with Phase 4 confirmation, biorepository, & natural history database. People are dying daily. We can't wait. 178 days

.Dr. Marty Makary Secretary Kennedy FDA Biologics, As one of the (cell therapy) NurOwn Citizens' Petitioners fighting for my life—and the lives of tens of thousands with 100% fatal #ALS—I'm terrified For 156 years, this disease has killed everyone with ZERO treatments providing any hope of

The U.S. 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

Get ready for this one. The top 13 ALS ASSOCIATION EXECS were paid $3,991,974 in ONE year...for 37.5 hours per week. This now exceeds 5.5% of total ALSA revenue! All while #NurOwn Ph4 awaits funding. Which would be better for #ALS pALS? RETWEET if you give ASF about #ALS failure!

.Dr. Marty Makary Secretary Kennedy Vinay Prasad MD MPH FDA Biologics, 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

47 DAYS OVERDUE. For the FDA, it’s a delay. For Veterans fighting #MilitaryServiceRelatedALS, it’s a lifetime denied Vinay Prasad MD MPH FDA Biologics is leaving behind Veterans who served our country 1 of every 6 ALS deaths are Veterans. HORRIFIC & 100% FATAL since identified in 1869.

Since 9/11, three times more Veterans have lost their lives to #ALS than those lost in combat in Iraq and Afghanistan combined. Let’s not forget, #NurOwn is THE most important treatment still pending Approval for our vets living with ALS. Approve the citizens petition and