Ken M

Chiefs, Yankees and golf fan. Hoping ALS patients get access to needed treatments.

[Ken M @kjmark]

@MinoShah @US_FDA @DrCaliff_FDA @FDACBER 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

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

Heartened by @FDA_KyleD and @FDA leadership who are enacting changes to help #raredisease communities.

You've accepted refiled BLAs for #huntingtons and #Duchenne. Now is the time to respond to the #NurOwn Citizens Petition containing data showing a five-year survival benefit compared to #ALS natural history.

@FDAdrugs and Karim Mikhail, invite @BrainstormCell to refile the BLA.

#EndALS #mnd #StemCells #CitizenScientist

[Ken M @kjmark]

@AngelaBelcamino See-saw politics, party in power overreaches on policies. 4 reasons Dems winning on policies they will try to reverse: support allies and Ukraine instead of Putin, ICE not focusing on criminals, dismantling regulations protecting clean air and water, tax code favoring wealthy

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

The FDA has the chance to put its new Rare Disease Framework into action by granting the requests in the 313-pg Citizens' Petition and 330+ pg legal memo filed on Docket # FDA-2025-P-2109, much of which is based on real world evidence.

Like many #raredisease patients, people in the #ALS community had to become citizen scientists. We collected ~ 8 yrs RWE after a 28-week P3 RCT ended in 2020. Some data came from additional dosing in EAP. Some was contained in Electronic Medical Records documented by treating neurologists for years after the P3 trial ended in 2020. Some improvements in function were documented in videos.

That RWE showed unprecedented trach-free survival benefits as of October 2026. In the 10-person EAP:

🔹5 yr survival = 100% EAP vs <20% ALS natural history

🔹5 yr median survival benefit = 7.5 yrs EAP vs 2.5 yrs ALS natural history

🔹5/10 people still alive, trach-free

🔹EAP's 51 patient treatment years ≈ patient treatment years in short 28-wk P3 trial

🔹Median not yet reached by those in the treatment arm in the trial and EAP (N-N) where 4/6 are still alive (range 7.5 - 9.5 yrs) with 81% lower risk of trach or death

Although OS and trach-free survival were pre-specified, the data were not yet ripe when the 28-week P3 trial ended. Now it is. The FDA has never considered this #RWE. The data confirm the AdComm testimony of renowned PI experts, treating neurologists and the post hoc findings of the 28-week trial.

The FDA approves cancer therapies based on 6 months of additional survival. NurOwn has extended survival by FIVE YEARS in a 100% terminal rare disease with no disease modifying treatments.

@FDA_KyleD @FDADrugs
The Rare Disease Framework will take years to implement -- years people with ALS don't have. Thus, we are asking the FDA and CBER to use its regulatory flexibility, act urgently, and grant accelerated approval of #NurOwn.

#EndALS #ALS #MND #rarediseases #clinicaltrials #CitizenScientists #PatientAdvocacy #neurology #neurologist

@DorisMatsui @Bilirakis @RepGuthrie @RepJohnJoyce @RepGregMurphy @RepMGriffith @RepMMM @RepAndyHarrisMD @RepSchakowsky @HouseCommerce @EnergyCommerce

@GOPHELP @SenateAging @SenateAgingDems
@ChrisCoons @lisamurkowski @SenBillCassidy @SenRickScott @SenRonJohnson @SenatorWicker @ChuckGrassley @LeaderJohnThune @SenWhitehouse @RandPaul @SenJohnBarrasso

@DrHMelamed @houmanhemmati @CNBC @nyahphengsitthy @hmac8 @biospace @JefAkst @AP_FDAwriter @SquawkCNBC @BeckyQuick

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

If #CBER wants to honor the new framework, it can start by paying attention to the unprecedented survival data in the #NurOwn citizens' petition -- the ultimate clinically meaningful endpoint -- and the 2002 Public Comments at the AdCom explaining #ALS patients' tolerance for risk.

It's been over 500 days on a 180-day regulatory deadine. In that time, more than 8,000 Americans with ALS have #DiedWaiting.

#EndALS #RareDiseases

@FDAdrugs
@houmanhemmati @LeaderJohnThune @ChuckGrassley @SenatorWicker @RonJohnsonWI @SenGillibrand @SenRickScott @RandPaul

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

"Catch up" #CBER? For 500+ days, @FDADrugs has possessed unprecedented survival data in #NurOwn Citizens' Petition but has failed to respond.

Real-world Evidence from EAP:
• 100% 5 yr trach-free survival vs <20% in natural history
• >7.5 yr median trach-free survival vs 2.5 yrs natural history.

It's been 500+ days on @FDA's 180-day regulatory deadline to respond to the citizen's petition -- at the cost of 8k+ lives.

@FDA_KyleD
We need action, not speeches.

#EndALS #rarediseases

@houmanhemmati @LeaderJohnThune
@ChuckGrassley @SenatorWicker
@RonJohnsonWI @SenGillibrand
@SenRickScott @RandPaul

@Bilirakis @DorisMatsui @RepGuthrie @RepMMM @RepJohnJoyce @RepGregMurphy @RepDonBacon @RepMGriffith @RepSchakowsky

[Ken M @kjmark]

@jessenewell @hbtCHIEFS Hicks very close to getting called block in back at end of play. Don’t even get close to tackler once he’s past the sticks.

[Ken M @kjmark]

@Humble_Ty19 @RealMNchiefsfan Great game! Get well soon! @tonyfinaugolf had similar injury celebrating after making hole in 1 and returned quickly. (@limpbroozkit begged @FDA for #ALS treatment #nurown 3 years ago and died waiting. Thousands other died waiting last 10 years. #FDA needs to #ApproveNurOwn

[Rain Consulting Group @RainConsulting]

Here's another key stat for ya. 0% cure rate of ALS before Trump and 0% with Trump. A big reason for this is because effective treatments continue to sit on the shelf as patients die waiting. I also saw from a credited source that Trump actually wanted NurOwn approved, but certain Advocacy groups recommended against it last minute. (think about that for a second) Things have changed substantially since then, NurOwn has much more data within its totality of evidence showing it prolongs life. Yet here we are. Still waiting. Patients still dying of this 100% fatal disease. The NurOwn Citizens Petition is still pending. Incredible. @PeterPitts @LoriMills4CA42 @FDA_KyleD

[Ken M @kjmark]

@MinoShah @AANmember @NataliaRostMD @LyellJ One of their concerns is on patient access so they propose no access as recommendation. Makes zero sense. Especially for heterogeneous terminal ALS disease with no good treatment options resulting in a horrific life. Shameful them turning their backs on dying patients.

[Shah Minokadeh, M.D. @MinoShah]

Can @AANmember or its current & future president, @NataliaRostMD & @LyellJ, explain to a physician dying of ALS why the Field of Neurology hasn't dedicated itself as a whole to fighting for its dying patients, like oncology?

Please read the shameful letter from the #AAN to the FDA discouraging the FDA approval of Intrathecal treatments.

I would be ashamed. I don't know what you do at these meetings. For 157 years ALS patients have been dying with no hope...
WHY ARE YOU NOT FIGHTING FOR AN FDA NEUROLOGY CENTER of EXCELLENCE JUST AS WAS DONE EXTREMELY SUCCESSFULLY FOR ONCOLOGY?

I think the majority of you are not suited to be physicians. So many of you don't care if we die .

Here is the list of untreatable diseases seen by Neurologists, but are sent home without hope.

**Currently incurable (no cure) neurological diseases commonly seen by a neurologist**

Neurodegenerative
- Alzheimer’s disease
- Frontotemporal dementia
- Lewy body dementia
- LATE (limbic-predominant age-related TDP-43 encephalopathy)
- Parkinson’s disease
- Multiple system atrophy
- Progressive supranuclear palsy
- Corticobasal degeneration
- ALS (amyotrophic lateral sclerosis)
- Primary lateral sclerosis
- Progressive muscular atrophy
- Progressive bulbar palsy
- Kennedy’s disease (SBMA)
- Huntington’s disease
- Creutzfeldt–Jakob disease and other prion diseases (including fatal familial insomnia)

White-matter / inherited
- Most leukodystrophies (50+ types; most still have no disease-modifying therapy)
- Most hereditary ataxias / spinocerebellar ataxias
- Most Charcot–Marie–Tooth types and many other inherited neuropathies

Muscle / nerve / other
- Many muscular dystrophies (some subtypes now have treatments; many do not)
- Most mitochondrial disorders affecting the nervous system
- Drug-resistant / refractory epilepsy (about one-third of epilepsy)
- Various rare genetic proteinopathies and repeat-expansion diseases

**Note:** “No cure” means the underlying process cannot be stopped or reversed. Many of these still have symptom treatments or modest disease-slowing drugs. Neurologists also treat many conditions that *are* treatable (most migraine, most epilepsy, myasthenia, CIDP, timely stroke care, etc.).

[Ken M @kjmark]

@FDACBER @FDACDERDirector @DrCaliff_FDA @FDADrugs @realDonaldTrump @DonaldJTrumpJr @VPrasadMDMPH @VP Opinion: Capricor, Replimune illustrate why FDA must listen to rare disease specialists https://t.co/uVOrij5OXc

[Shah Minokadeh, M.D. @MinoShah]

Now replace the 8 years with 11 years.

[Ken M @kjmark]

@ZelenskyyUa You have support of most Americans, we pray this war will end on good terms for the good people of Ukraine 🇺🇦.

[Shah Minokadeh, M.D. @MinoShah]

1/9 @MyronRolle — As a physician fighting #ALS, the most shocking realization of the disease is that @FDACBER @US_FDA don't value ALS lives

I am pleading with you to help us do what generations of patients have failed to achieve. Strategic advisor to @NFLPA, @ChrisJohnson28 & future @NFL players who will get #ALS, NEED YOU.

Former NFL players = 4X the risk of developing & dying of ALS compared to the general population.

The lifetime risk of the general population getting #ALS = is 1 out of every 300 people.

The global incidence of ALS is expected to rise by 40% over the next decade.

I hope that Chris & others will hold you accountable. This is NOT something to simply add to your CV.

@PatMcAfeeShow
@DeionSanders
@AdrianPeterson
@MoneyLynch
@DeSeanJackson10
@CutonDime25
@AaronDonald97
@markingramII
@camjordan94
@VonMiller
@CrosbyMaxx
@JeromeBettis36
@D_Hest23
@AndrewWhitworth
@DBrooks55
@REALPACMAN24
@thereal_lendale
@VinceYoung10
@EdgerrinJames
@JCTretter @ReevesMaybin @JJWatt @Ochocinco @ShannonSharpe @michaelstrahan

[Ken M @kjmark]

@MinoShah @REALPACMAN24 @michaelstrahan @ShannonSharpe @NFL @NFLPA @GMA @SecKennedy @FDA_KyleD Safe &amp; effective for many people the last 10+ years there is no reason @FDACBER @SecKennedy should not approve #NurOwn for @ChrisJohnson28 and all other #ALS patients. It’s beyond cruel to withhold treatment which patients and family members have demanded access! @realDonaldTrump

[Shah Minokadeh, M.D. @MinoShah]

.@MoneyLynch @michaelstrahan @ShannonSharpe, former @NFL players are roughly 4X more likely to develop/die from #ALS. This could be you tomorrow!
@NFLPA

We need someone with a platform to advocate for dying ALS. @GMA, invite @SecKennedy @FDA_KyleD, & ask them why they have not given a response to our NUROWN CITIZENS' PETITION- 6 months after the deadline.

ALS =100% FATAL since 1869, but hopeless dying ALS get nothing but ignored or CRUEL regulatory RIGIDITY from the @FDACBER.

I was 1 of the petitioners. #NurownWorks #DyingWaiting

#ALS patients have been lied to by the @US_FDA repeatedly. This is because we have BROKEN BODIES that don't allow us to advocate, and we have NO BIG PHARMA allies.

@ChrisJohnson28 & the next former #NFL player to be struck down at the prime of your life need YOU!

#MichaelStrahan & #ShannonSharpe. #ALS doesn't care how successful or how much $ you have. It might really be you tomorrow.
@RGIII @NFLPA @JaMorant @ochocinco @Titans @PatrickMahomes @JCTretter @ReevesMaybin -
it can be any one of you next, but it doesn't have to be a death sentence for everyone diagnosed in 2026. Chris is still alive & WANTS TO FIGHT!

We need the currently healthy public to fight far #ChrisJohnson28 & ALL with ALS NOW & IN THE FUTURE.

EVERY DAY, more Americans are being given the #ALS death sentence

ALS DOESN'T DISCRIMINATE!
IT STRIKES RICH /POOR, CEOS/CELEBRITIES, ANY AGE, ETHNICITY, RELIGION, > 90% HAVE NO FAMILY HISTORY & IT'S BECOMING MORE COMMON

@RobertKennedyJr, your betrayal seems the worst. I want to remind you that the FDA's mission statement is to protect public health.
It has no disclaimer that says, "only if they have Big Pharma allies" or " only if they can advocate for themselves and force us to ACT"

@SenRonJohnson, we desperately need your leadership,, or the #ALS community is completely _forgotten at the @US_FDA. Every new generation of dying WITHOUT HOPE denied effective NUROWN.

The NUROWN CITIZEN'S PETITION was submitted a year ago exactly this Friday. The FDA deadline for a response was on 12-30-2025. The FDA is ignoring our dying pleas for a response 6 months after we were owed a response.

@realDonaldTrump @RepGuthrie @DrOz @DrOzCMS @SenatorCollins @RonJohnsonWI @DrNealDunnFL2 @LeaderJohnThune @RepGusBilirakis @SenatorWicker @RepBarragan @SenatorBaldwin @SenMarkey @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepMikeQuigley @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @PeterPitts @nflcommish

[Ken M @kjmark]

@MinoShah @MoneyLynch @michaelstrahan @ShannonSharpe @NFL @NFLPA @GMA @SecKennedy @FDA_KyleD Safe &amp; effective for many people the last 10+ years there is no reason @FDACBER @FDACBER @SecKennedy should not approve #NurOwn for @ChrisJohnson28 and all other #ALS patients. It’s beyond cruel to withhold treatment which patients and family members have demanded access!

[Shah Minokadeh, M.D. @MinoShah]

.@MoneyLynch @michaelstrahan @ShannonSharpe, former @NFL players are roughly 4X more likely to develop/die from #ALS. This could be you tomorrow!
@NFLPA

We need someone with a platform to advocate for dying ALS. @GMA, invite @SecKennedy @FDA_KyleD, & ask them why they have not given a response to our NUROWN CITIZENS' PETITION- 6 months after the deadline.

ALS =100% FATAL since 1869, but hopeless dying ALS get nothing but ignored or CRUEL regulatory RIGIDITY from the @FDACBER.

I was 1 of the petitioners. #NurownWorks #DyingWaiting

#ALS patients have been lied to by the @US_FDA repeatedly. This is because we have BROKEN BODIES that don't allow us to advocate, and we have NO BIG PHARMA allies.

@ChrisJohnson28 & the next former #NFL player to be struck down at the prime of your life need YOU!

#MichaelStrahan & #ShannonSharpe. #ALS doesn't care how successful or how much $ you have. It might really be you tomorrow.
@RGIII @NFLPA @JaMorant @ochocinco @Titans @PatrickMahomes @JCTretter @ReevesMaybin -
it can be any one of you next, but it doesn't have to be a death sentence for everyone diagnosed in 2026. Chris is still alive & WANTS TO FIGHT!

We need the currently healthy public to fight far #ChrisJohnson28 & ALL with ALS NOW & IN THE FUTURE.

EVERY DAY, more Americans are being given the #ALS death sentence

ALS DOESN'T DISCRIMINATE!
IT STRIKES RICH /POOR, CEOS/CELEBRITIES, ANY AGE, ETHNICITY, RELIGION, > 90% HAVE NO FAMILY HISTORY & IT'S BECOMING MORE COMMON

@RobertKennedyJr, your betrayal seems the worst. I want to remind you that the FDA's mission statement is to protect public health.
It has no disclaimer that says, "only if they have Big Pharma allies" or " only if they can advocate for themselves and force us to ACT"

@SenRonJohnson, we desperately need your leadership,, or the #ALS community is completely _forgotten at the @US_FDA. Every new generation of dying WITHOUT HOPE denied effective NUROWN.

The NUROWN CITIZEN'S PETITION was submitted a year ago exactly this Friday. The FDA deadline for a response was on 12-30-2025. The FDA is ignoring our dying pleas for a response 6 months after we were owed a response.

@realDonaldTrump @RepGuthrie @DrOz @DrOzCMS @SenatorCollins @RonJohnsonWI @DrNealDunnFL2 @LeaderJohnThune @RepGusBilirakis @SenatorWicker @RepBarragan @SenatorBaldwin @SenMarkey @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepMikeQuigley @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @PeterPitts @nflcommish

[Ken M @kjmark]

@MinoShah @michaelstrahan @NFL @NFLPA @GMA @SecKennedy @FDA_KyleD Safe &amp; effective for many many people the last 10+ years there is no reason @FDACBER @FDACBER @SecKennedy should not approve #NurOwn for @ChrisJohnson28 and all other #ALS patients. It’s beyond cruel to withhold treatment which patients and family members have demanded access!

[Shah Minokadeh, M.D. @MinoShah]

.@michaelstrahan, former @NFL players are roughly 4X more likely to develop/die from #ALS. This could be you tomorrow!
@NFLPA

We need someone with a platform to advocate for dying ALS. @GMA, please invite @SecKennedy @FDA_KyleD, & ask them why they have not given a response to our NUROWN CITIZENS' PETITION- 6 months after the deadline.

ALS =100% FATAL since 1869, but hopeless dying ALS get nothing but ignored or CRUEL regulatory RIGIDITY from the @FDACBER.

I was 1 of the petitioners. #NurownWorks #DyingWaiting

#ALS patients have been lied to by the @US_FDA repeatedly. This is because we have BROKEN BODIES that don't allow us to advocate, and we have NO BIG PHARMA allies.

@ChrisJohnson28 & the next former #NFL player to be struck down at the prime of your life need you, @michaelstrahan. It doesn't matter how successful or how much $ you have. It might really be you tomorrow.
@RGIII @NFLPA @JaMorant @ochocinco @Titans @PatrickMahomes @JCTretter @ReevesMaybin -
it can be any one of you next, but it doesn't have to be a death sentence for everyone diagnosed in 2026. Chris is still alive & WANTS TO FIGHT!

We need the currently healthy public to fight on @ChrisJohnson28 & ALL with ALS

EVERY DAY, more Americans are being given the #ALS death sentence

ALS DOESN'T DISCRIMINATE!
IT STRIKES RICH /POOR, CEOS/CELEBRITIES, ANY AGE, ETHNICITY, RELIGION, > 90% HAVE NO FAMILY HISTORY & IT'S BECOMING MORE COMMON

@RobertKennedyJr, your betrayal seems the worst. I want to remind you that the FDA's mission statement is to protect public health.
It has no disclaimer that says, "only if they have Big Pharma allies" or " only if they can advocate for themselves and force us to ACT"

@SenRonJohnson, we desperately need your leadership,, or the #ALS community is completely forgotten at the @US_FDA. Every new generation of dying WITHOUT HOPE denied effective NUROWN.

The NUROWN CITIZEN'S PETITION was submitted nearly a year ago. The FDA deadline for a response was on 12-30-2025. The FDA is ignoring our dying pleas for a response nearly 6 months after we were owed a response.

@realDonaldTrump @RepGuthrie @DrOz @DrOzCMS @ChuckGrassley @RonJohnsonWI @DrNealDunnFL2 @LeaderJohnThune @RepGusBilirakis @SenatorWicker @RepBarragan @SenatorBaldwin @SenatorHassan @SenMarkey @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepMikeQuigley @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis @PeterPitts