Ashley Chernikovich
@AshleyCherniko1
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Fighting a terminal and fatal neuromuscular Mnd/Als since April 2018. Doing what I can with spreading awareness and advocacy. Learning and Research
Belvidere, Illinois
Joined August 2022
Tell it like it is
@MinoShah @DrMakaryFDA @SecKennedy @FDACBER @POTUS @RobertKennedyJr @RepAndyHarrisMD @DrOzCMS @DrOz @RepDonBacon @LeaderJohnThune If ALS was contagious, the treatments that FDA is preventing us to use, would of been approved yrs ago like NurOwn, T-regs & CUATSM. But ALS is worse, it’s 100 % FATAL! Promises don’t save lives, answers do! Answer us with NurOwn & the other 2. What would u be asking if u had ALS
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12/12 @US_FDA @FDACBER @SecKennedy @DrMakaryFDA @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
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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
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10/12 @DrMakaryFDA @MartyMakary 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
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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
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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
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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
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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)
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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)
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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
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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
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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:
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1/12 @DrMakaryFDA @SecKennedy @FDACBER, 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
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i speak for everyone when i say that drone shows are way better than fireworks
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Help ALS patients - Remove Chaim Lebovits as CEO of Brainstorm Cell Therapeutics, Inc. - Sign the Petition! https://t.co/qGruY2cKRT via @Change
change.org
Help ALS patients - Remove Chaim Lebovits as CEO of Brainstorm Cell Therapeutics, Inc.
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Enough fiddling around with our lives Mr. Lebovits, Chaim; Either file the BLA or step down as CEO!!!! @BrainstormCell @Cylebo @MaryKayTurner1 #Nurownworks
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Such a shame. THIS is the bold leadership #ALS needed 4 years ago. I guess votes really do have consequences. While ex- @US_FDA "experts" approved failed @amazon supp based drugs or cut backroom deals, this @US_FDA is serious about rare diseases #endals
https://t.co/B5pvf9wf1h
fiercebiotech.com
The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency. | The FDA is introducing a...
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.@RealEricDane knows it We MUST unite behind @MGHNeurology, the CLEAR LEADER in #ALS research/treatments The Healey Platform trial is a #GameChanger, offering access to treatments at over 70 locations nationwide, faster results, fewer people receiving placebo, cheaper trial
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