Kim French @kimfrench0405 Twitter profile

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@Sharo_Cervantes

Kim French

@kimfrench0405

8 months

My ALS community and family , I need support and love right now. My husband of over 19 years has decided he wants a divorce. I am still in shock. ALS tore through and ripped our marriage apart. #fuckALS

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Kim French

@kimfrench0405

2 years

Sometimes I’m still in shock that I have #ALS it’s like living the painful diagnosis over and over. #ENDALS

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Kim French

@kimfrench0405

7 months

Even though my brother and sister in law make sure there’s always someone here to take care of me, I’ve never felt more alone. I’ve cried so much I physically cannot cry anymore

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Kim French

@kimfrench0405

10 months

Today is my 41st birthday! Fuck you #ALS

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Kim French

@kimfrench0405

2 years

I want to get in my wheelchair and take my bipap and camp out on the steps of the @US_FDA until they approve #NurOwn #ALS

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Kim French

@kimfrench0405

2 years

I was diagnosed on a Friday the 13th. #ENDALS

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Kim French

@kimfrench0405

2 years

Signed my Living Will and DNR today. #als has taken so much from me and my family. #ENDALS

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Kim French

@kimfrench0405

2 years

Today is my oldest baby girl’s 15th birthday I hope I’m able for many more celebrations #EndALS

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Kim French

@kimfrench0405

2 years

I hate #ALS it’s a big black hole dragging me into the darkness kicking and screaming. Please @DrCaliff_FDA you can help! #NurOwn works

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Kim French

@kimfrench0405

3 years

Dear @BrainstormCell my breathing is declining. My legs grow weaker. I need #nurown now. Please #filetheBLA we need your help

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Kim French

@kimfrench0405

1 year

Today is my 5 year anniversary of my #ALS diagnosis. Tomorrow I’ll be living on borrowed time but today #ALS can suck it. #ENDALS

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Kim French

@kimfrench0405

2 years

I just don’t want to be sick anymore. #ENDALS @DrCaliff_FDA I don’t want to be a burden any longer

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Kim French

@kimfrench0405

2 years

Just got my Relyvrio one day early. Here’s hoping to no side effects #ENDALS

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Kim French

@kimfrench0405

3 years

Dear @BrainstormCell @Cylebo please don’t let my fight be in vain #filetheBLA for #NurOwn

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Kim French

@kimfrench0405

1 year

Dear @DrCaliff_FDA I have a fly in my house. Why should you care? Well, I can’t shoo it away because I have #ALS . It’s absolutely torture. I’m thinking if I’d been able to decide whether or not to try #NurOwn when I was diagnosed I could do more than shoo a fly. #NurOwnWorks

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Kim French

@kimfrench0405

2 years

My experience with @synapticure has been nothing but pure excellence. My care coordinator, Crystal has always made me feel # 1 priority. If you have #ALS you need @synapticure and follow @bsw5020 #EndALS

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Kim French

@kimfrench0405

1 year

I did my best #EndALS

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Kim French

@kimfrench0405

3 years

Our mom is #dyingwaiting @DrWoodcockFDA @US_FDA @CBSNews @ABC @NBCNews @CNN @RepLaHood @GMA @USATODAY @TODAYshow we need treatments now. We can’t wait.

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Kim French

@kimfrench0405

1 year

#NurOwn may not help me because it’s too late but it will help some and that’s worth fighting for @DrCaliff_FDA

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Kim French

@kimfrench0405

2 years

I’m so effing sick of #ALS @DrCaliff_FDA there is so much suffering and dying. You can help us please. #DyingWaiting #NurOwn #ENDALS

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Kim French

@kimfrench0405

3 years

Dear @BrainstormCell @Cylebo please #filetheBLA for #NurOwn please let us know you’re listening

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Kim French

@kimfrench0405

2 years

I absolutely love @iamalsorg and @synapticure they have been beyond amazing

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Kim French

@kimfrench0405

2 years

I’m catching a cold. @DrCaliff_FDA do you know how much it is going to suck with #ALS I bet if I had gotten the chance for #nurown months ago it wouldn’t be so hard on my dying body

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Kim French

@kimfrench0405

1 year

Family needs support too. The #ALS monster attacks them physically, mentally and financially too. Let’s #ENDALS @DrCaliff_FDA we need accelerated approval

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Kim French

@kimfrench0405

4 years

I’m sick of crying from what ALS has taken from me. @SteveFDA @realDonaldTrump @US_FDA @FDACBER @SecAzar @JoeBiden @KamalaHarris #NurOwn

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Kim French

@kimfrench0405

2 years

You know what?! Fucking fuck ALS ! #ENDALS

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Kim French

@kimfrench0405

1 year

Sometimes I’m just ready for the Peace and to ease the burden on my family. Really considering to just starting hospice and begin the process. #ENDALS

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Kim French

@kimfrench0405

2 years

I wish iPhone had an app that could turn your phone into an eye gaze. I’m not ready to give up my my phone. #Apple #ENDALS @AppStore @TobiiDynavox

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Kim French

@kimfrench0405

3 years

@people You need to run a story about how @US_FDA is refusing all #ALS patients life saving treatments and keep getting victimized by the same org that has benefited millions only to go to payroll and bonuses @als_now @Michell62614519

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Kim French

@kimfrench0405

3 years

You are literally killing me #DyingWaiting @US_FDA @DrWoodcockFDA

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Kim French

@kimfrench0405

1 year

Thank you Brooke

Brooke Eby

@limpbroozkit

1 year

My comments to the FDA leading up to the Nurown advisory committee on 9/27. I’ll post the link where you can add comments in my bio. #fda #nurown #adcom

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Kim French

@kimfrench0405

1 year

I am noticing that the UK and the US are sharing similarities in gaining access to promising therapies for 100% fatal disease ALS/MND. Why isn’t this world news? @NBCNews @ABC @CNN @MSNBC #EndALS #dyingwaiting

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Kim French

@kimfrench0405

7 months

#NewProfilePic

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Kim French

@kimfrench0405

1 year

This is so incredible! #NurownNext

I AM ALS

@iamalsorg

1 year

Breaking news: The FDA has approved Tofersen for SOD1 ALS! @US_FDA thank you for living up to your promise of regulatory flexibility for ALS. ALS community: YOU made this happen with your relentless advocacy. Remember that. Stay tuned for updates on access to this treatment!

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Kim French

@kimfrench0405

4 years

We are pleading for lives! Please @JoeBiden @VP @Cylebo @DrWoodcockFDA @FDACommissioner

sandra castillo cano

@sandrac37082124

4 years

We've been begging for Approval of treatments for a year.Many have lost their lives waiting.When are we going to get an answer?STOP!!Treatments NOW!! #AMX0035 & #NUROWN @US_FDA @EMA_News @FDACDERDirector @DrWoodcockFDA @SteveFDA @SKyriakidesEU @vonderleyen @AmylyxPharma @Cylebo

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Kim French

@kimfrench0405

4 years

@PascrellforNJ The passing of #HR8662 to give dying #ALS patients like me a chance to live. We need a chance to survive #DyingWaiting

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Kim French

@kimfrench0405

1 year

@sabrevaya You’re in Illinois right? Contact the Department of Human Rehabilitative Services (DoHRS) and the state pays for caregivers and even pays you for being @bsw5020 caregiver. I get like 52 hours a week. You can apply online too.

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Kim French

@kimfrench0405

4 years

@HHS_ASH Thank you for acknowledging us. All we’re asking is for you to speak to the President @realDonaldTrump and ask for an #EO for #NurOwn so that we may have a fighting chance to live. Sir, I have three young daughters and a veteran husband watching me die.

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Kim French

@kimfrench0405

2 years

@synapticure is one of the best things to happen to an #ALS patient

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Kim French

@kimfrench0405

3 years

Why do I feel @FDACBER @US_FDA @DrWoodcockFDA just blatantly don’t give a damn about #ALS patients? Maybe I need to just accept the fact that I’m going to die without a chance for treatment at the hands of the @US_FDA

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Kim French

@kimfrench0405

2 years

#ALS is ripping my family apart #ENDALS

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Kim French

@kimfrench0405

4 years

It seems that the @US_FDA and now @RareDiseases have a vendetta against the #ALS community. What is the problem? I think it’s time we deserve some answers! And supporting action! Our best interest is not a heart when you let innocent ppl die. @FDACommissioner @SteveFDA

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Kim French

@kimfrench0405

1 year

Today the ALS is winning #EndALS I fucking hate this disease

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Kim French

@kimfrench0405

5 years

Here’s your proof @US_FDA ! We need #NurOwn now! Executive Action please @realDonaldTrump @FLOTUS @VP @SecAzar @SenatorDurbin @SenDuckworth @WhiteHouse @US_FDA @FDACommissioner

No More Excuses ALS Watchdogs!

@als_now

5 years

Watch ABC Nightline to find out "if this is real". (Hint: it is) America finally will see why "No More Excuses!" ALS members like Thurman have fought so hard for months! #Thurmantough #ALSplea @realDonaldTrump @FLOTUS @WhiteHouse @VP @CraigReagan2 @ALS

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Kim French

@kimfrench0405

5 years

I’m dying too, we’re told life-saving treatment is not accessible to us because of red-tape. I feel like the refusal from the #FDA is a blatant definition of murder. Can we get Executive Action now please?!?! @AnnCurry here the story for your show! @WhiteHouse @SenDuckworth

Joanne Baia

@JoanneBaia

5 years

#ALS patient Bobby Forster- How can ANYONE think this is acceptable? #NurOwn trial @realDonaldTrump @POTUS @VP @FLOTUS @WhiteHouse @FDACommissioner @FDACBER @US_FDA @SGottliebFDA @HouseDemocrats @HouseGOP @SecAzar @FoxNewsResearch @NBCNews @foxandfriends

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Kim French

@kimfrench0405

5 years

@FDACommissioner Please do the right thing now and approve #NurOwn . So many lives will be lost by the end of September

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Kim French

@kimfrench0405

5 years

I am asking for assistance in contacting the President to use Executive Order to release the treatment, NurOwn to dying ALS patients. @als_now @POTUS @VP @WhiteHouse @GOP @DNC @realDonaldTrump @SenateFloor @SenDuckworth @SenatorDurbin @FLOTUS @US_FDA @FDACommissioner @HouseFloor

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Kim French

@kimfrench0405

5 years

National television is paying attention we need #NurOwn ! @FDACommissioner @FDACBER @US_FDA we need Executive Action please @realDonaldTrump @FLOTUS @VP @WhiteHouse @SecAzar @Surgeon_General @GOP @DNC

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Kim French

@kimfrench0405

3 years

Today was definitely an ALS day. First, I usually don’t wear my bipap when I nap but today I just needed it. I kept waking up from not breathing. Second, my voice just feels ready to give out. It hurts to talk. #nurown @US_FDA @DrWoodcockFDA @FDACBER @FDACDERDirector #ACTforALS

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Kim French

@kimfrench0405

4 years

#dyingwaitingALS I will probably die before I get access to treatments @NIH @HHS_ASH @NIHDirector @FDACBER @FDACommissioner @vp @realDonaldTrump @CNN @FoxNews @SecAzar @SteveFDA @DrWoodcockFDA @statnews @cnnheaIth

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Kim French

@kimfrench0405

5 years

What other proof do you need @FDACommissioner @US_FDA please help us @SecAzar @realDonaldTrump @WhiteHouse @SenDuckworth @SenatorDurbin

No More Excuses ALS Watchdogs!

@als_now

5 years

ALS patient can draw same bow again after 7 months of being unable to! Full story on ABC Nightline coming soon. Can @FDACBER name any approved drugs which have shown similar ability to REVERSE ALS symptoms? No, but but we have with NurOwn at NME. Approve now! #ENDALS #ALS #MND

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Kim French

@kimfrench0405

5 years

I am asking for assistance in contacting the President to use Executive Order to release the treatment, NurOwn to dying ALS patients. @POTUS @realDonaldTrump @VP @FLOTUS @US_FDA @FDACommissioner @FDAMedia @SenateFloor @SenDuckworth @SenatorDurbin @GOP @DNC @PressSec @WhiteHouse

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Kim French

@kimfrench0405

5 years

I think it’s time for an investigation @TodayWithBBB lives are lost daily to @alsassociation and @US_FDA

No More Excuses ALS Watchdogs!

@als_now

5 years

Ah, the old "page not found" trick. But we found it. Whoops. Looks like ALSA DOES fund Phase III trials, just not NurOwn. This is getting ridiculous, people. JUST ADMIT THE MISTAKE AND FIX! People are dying! #ENDALS #ALS #ALSplea @craigreagan2 NO MORE EXCUSES MUCH MORE COMING!

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Kim French

@kimfrench0405

4 years

@US_FDA Yet #NUROWN has been stuck in trials for 10 years

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Kim French

@kimfrench0405

4 years

@US_FDA To date, the @US_FDA has still ignored the cries for help from #theALSCommunity . We are dying! #NurOwn @FDACommissioner @SteveFDA @FDACBER

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Kim French

@kimfrench0405

1 year

Please go ❤️ her comment

Brooke Eby

@limpbroozkit

1 year

@MrBeast @MrBeast hear me out- I’m 34 with a terminal disease called #ALS (don’t I look just like Lou Gehrig?). Let’s get your $ toward a cure for a devastating, underfunded disease that kills someone every 90 minutes. You can be the next #icebucketchallenge .

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Kim French

@kimfrench0405

5 years

#nurown maybe I could pick up my two year old daughter that I’ve never picked up before! #ALSplea @US_FDA @FDACommissioner @SenDuckworth @FLOTUS @WhiteHouse @realDonaldTrump

Thurman

@ThurmanTough

5 years

Yes I do have ALS. December 2018 I could not pull the bow back. 2 injections NurOwn give me the ability to pull a 50 lbs Bow back.

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Kim French

@kimfrench0405

5 years

#ALSwarriors need #NurOwn now! @FDAMedia @US_FDA @FDACommissioner @vp @realDonaldTrump @FLOTUS @WhiteHouse @CNN @GMA @FoxNews @USATODAY @ABC @NBCNews @CBSNews @AnnCurry @RobinRoberts @HHS_ASH @SecAzar @SenatorDurbin @GOP @SenDuckworth @DNC @SpeakerPelosi @tedcruz

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Kim French

@kimfrench0405

4 years

@DrWoodcockFDA @FDACommissioner @US_FDA @POTUS @JoeBiden @VP @KamalaHarris @SenatorDurbin @SenDuckworth @FDACBER

Jeff Fortenberry

@JeffFortenberry

4 years

My brother-in-law's death from #ALS connected me to so many courageous persons suffering from this cruel disease. The @US_FDA just shattered hope, not approving the treatment NurOwn because it only helped some. We can’t take much more. Is our government here to help?

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Kim French

@kimfrench0405

5 years

@realDonaldTrump please Sir, I pray and ask with everything I have you see this tweet. Please use #ExecutiveDecision to force the @US_FDA to release the life saving treatment #NurOwn for dying #ALS patients. Please help us.

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Kim French

@kimfrench0405

4 years

@bsw5020 I fight for my daughters

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Kim French

@kimfrench0405

5 years

Here’s the proof @US_FDA @FDACommissioner @FDAMedia we need #NurOwn now! Please use Executive Action @POTUS @realDonaldTrump @FLOTUS @SenDuckworth @SenatorDurbin @PressSec @SecAzar @SecondLady @VP @DNC @WhiteHouse @GOP

Shah Minokadeh, M.D.

@MinoShah

5 years

#Nurown approval for all w #ALS NOW! @potus @VP @SenRonJohnson @RonJohnsonWI @SecAzar @cylebo @marykayturner1 @FDACommissioner @FDACBER @LauraCaliguiri @RepBrianFitz @KenCalvert @RepJasonCrow @RepTerriSewell @SecretaryCarson @SenTedCruz

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Kim French

@kimfrench0405

4 years

@SteveFDA #ALS patients have been begging for #NurOwn way before COVID. Can you at least tell us why? Why are you ignoring us? Why won’t you issue EUA for #NurOwn ? It’s surpassed the criteria needed.

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Kim French

@kimfrench0405

5 years

#ALSplea @FDACommissioner @US_FDA @realDonaldTrump @SenDuckworth @SenatorDurbin @AnnCurry @RobinRoberts @SenTedCruz @FLOTUS @Surgeon_General @SecAzar

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Kim French

@kimfrench0405

5 years

#NurOwn now! #ALSplea help us we need Executive Action @realDonaldTrump @FLOTUS @VP @WhiteHouse @US_FDA @FDACommissioner @FDACBER @SenDuckworth @SenatorDurbin @GOP @DNC @SpeakerPelosi @SenTedCruz @SecAzar human interest story @AnnCurry @RobinRoberts

Mark bedwell AlS

@Markbedwell11

5 years

@dbellina3 @Loftus @US_FDA NurOwn needs approved now And no more questions asked. There are ALS Pals dying every day and this is unacceptable. We have the right to live so fulfill are right now. Fda U have seen proof that it works

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Kim French

@kimfrench0405

4 years

@SteveFDA I’m sure these committees would not recommend you ignore the ALS. I do, however, see them urging you to follow your own policy an issue EUA for #Nurown and saving lives.

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Kim French

@kimfrench0405

4 years

@JeffFortenberry @iamalsorg Thank you. This is such a devastating disease

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Kim French

@kimfrench0405

2 years

Hearing the busy sounds from my kitchen. Seeing the excitement of Christmas in my children’s eyes. All from the sidelines. Thanks ALS #ENDALS

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Kim French

@kimfrench0405

1 year

@CBSEveningNews @DrLaPook Please do a story about how the @US_FDA is not using accelerated approval of safe and effective therapies in the pipeline. They are literally killing us in the #ALS community. #EndALS

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Kim French

@kimfrench0405

5 years

This has gone on long enough @US_FDA @FDACommissioner @FDACBER @HHS_ASH @SecAzar @AnnCurry @RobinRoberts @GMA @USATODAY @TODAYshow @CNNnewsroom @cnnbrk #istandwithmatt

No More Excuses ALS Watchdogs!

@als_now

5 years

This is f!%king heroic. Hey @FDACommissioner @FDACBER @US_FDA , your call. ALS patient refusing to eat because of your SIX YEAR incompetence. How many will join? Maybe we should do the same over NurOwn, FDA? NO HELP, ALSA? ALS patients are ready to fight. #ALSstarvation #ALS @CNN

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Kim French

@kimfrench0405

2 years

@angeldawnpopp I’m getting ready to start Relyvrio and put it through my tube. I’m so worried about the side effects. I’m so sorry is happening. @DrCaliff_FDA we need #NurOwn

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Kim French

@kimfrench0405

3 years

I also am your constituent please @SenDuckworth cosponser #ACTforALS

Brian Wallach

@bsw5020

3 years

Dear @SenDuckworth , I am an Illinois resident living with ALS. My wife worked on your 1st congressional campaign. We have waited for you to co-sponsor #ACTforALS . To do what you have done so many times before and fight for our veterans and those marginalized by the system…

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Kim French

@kimfrench0405

4 years

@SteveFDA when will @US_FDA use the same urgency for dying ALS patients? #AskFDA

Join the Q&A!👇

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Kim French

@kimfrench0405

2 years

@DrCaliff_FDA my thoughts exactly

Stew

@jonstew1982

2 years

Here I sit wondering if this will be my last #Easter with my #family . Without #treatments #ALS patients are always left to wonder. No #NurOwn in my #easterbasket #HeIsRisen #SOS #EndALS @BrainstormCell @Cylebo @DrCaliff_FDA @US_FDA

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Kim French

@kimfrench0405

5 years

Yes we are being ignored @FDACBER @US_FDA we need #NurOwn and #EO @realDonaldTrump @SecAzar @VP @FLOTUS @WhiteHouse

Lee Glenn 🇺🇸 ♿ 🏳️‍🌈 🐱 🌊🌊🌊

@ALSwarriorLeeG

5 years

Yes, but far too many of us don't have access to this potentially life saving treatment. We are being ignored, and left to die a brutal death. #IamALS #StopALS

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Kim French

@kimfrench0405

5 years

Help us @POTUS @realDonaldTrump @SecAzar @SenateFloor @VP @FDACommissioner @US_FDA @SenatorDurbin @SenDuckworth @DNC @GOP @WhiteHouse @SpeakerPelosi @SenTedCruz

Suzanne Beers

@SuzanneBeers2

5 years

There are Americans who suffer with ALS a devastating disease that ends in death. We need more support from the President. There are companies that can provide cures and hope . Non help we need Brainstorm and their Nurown.

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Kim French

@kimfrench0405

4 years

@SecAzar @CMSGov @HRSAgov When is going to be time for ALS patients? We don’t have time we’re dying too fast. Please approve #NurOwn

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Kim French

@kimfrench0405

5 years

#ALSplea @US_FDA @FDACommissioner @FDACBER @SenDuckworth @SecAzar @FLOTUS @VP @WhiteHouse @AnnCurry

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Kim French

@kimfrench0405

2 years

@DrCaliff_FDA @US_FDA @MCERSI I’m speechless. #NurOwn works! Why does the @US_FDA continually ignore the #ALS community? It has nothing to do with science and more to do with money

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Kim French

@kimfrench0405

4 years

@US_FDA @NIH You have treatments in trials that are working!!! You committed to completely ignoring our pleas to live. @als_now @FDACommissioner @SecAzar @SteveFDA

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Kim French

@kimfrench0405

5 years

Executive action for #nurown now please! @SenDuckworth @realDonaldTrump @SecAzar @VP @SenatorDurbin @FLOTUS

Thurman

@ThurmanTough

5 years

@realDonaldTrump We are getting robbed Mr @realDonaldTrump Our Lives is on the line and we need NurOwn for all ALS people.

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Kim French

@kimfrench0405

2 years

@DrCaliff_FDA does your 5 year old feed you? I bet not. Maybe with #NurOwn I can regain the ability to feed myself. #ALS

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Kim French

@kimfrench0405

4 years

@richardmarx Frustrated, see I’m dying from #ALS and fight daily to gain access to lifesaving treatments stuck in inhumane trials through the @US_FDA . Maybe you can help us? @iamalsorg @als_now

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Kim French

@kimfrench0405

5 years

#NurOwn please @realDonaldTrump @FLOTUS @VP @WhiteHouse @SecAzar @Surgeon_General

David Stone

@DavidSt87034021

5 years

Mr. President, I have ALS, looking at going to Mexico or China for stem cell treatment that the greatest medical system in the world cannot supply because the FDA will not approve Nurown based on current phase 3 results. @POTUS @realDonaldTrump @FDACommissioner @bryne @martharoby

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Kim French

@kimfrench0405

4 years

@US_FDA @DukeMargolis #NurOwn now please

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Kim French

@kimfrench0405

5 years

#NurOwn @WhiteHouse @VP @realDonaldTrump @FLOTUS @SenatorDurbin @US_FDA @SenDuckworth @AnnCurry @FDACommissioner @PressSec @SecAzar @HHSGov @CBSNews @NBCNews @HHS_ASH @Oprah @ABC

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Kim French

@kimfrench0405

5 years

@FDACommissioner @US_FDA would that be #NurOwn ??? You literally hold our lives in your hands!!!

U.S. FDA

@US_FDA

5 years

In our latest #FDAVoices , read about FDA’s five programs aimed at expediting patient access to important drugs that treat serious or life-threatening conditions.

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Kim French

@kimfrench0405

5 years

#ALSwarriors need #NurOwn now! @FDAMedia @US_FDA @FDACommissioner @vp @realDonaldTrump @FLOTUS @WhiteHouse @CNN @GMA @FoxNews @USATODAY @ABC @NBCNews @CBSNews @AnnCurry @RobinRoberts @HHS_ASH @SecAzar @SenatorDurbin @GOP @SenDuckworth @DNC @SpeakerPelosi @tedcruz

Mark bedwell AlS

@Markbedwell11

5 years

@pulte Two ALS patient getting better and having fun together. Let’s put a stop to Als ask me how

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Kim French

@kimfrench0405

4 years

@SteveFDA Don’t forget others need your attention too. We need #NurOwn now

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Kim French

@kimfrench0405

2 years

This is a long shot but @elonmusk can you use your Twitter platform and your resources to bring awareness and funding for #ALS ? I and thousands more are dying from this horrific disease.

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Kim French

@kimfrench0405

3 years

I can’t wait for #congressionalhearing Thursday. I want the @US_FDA to be held accountable. @FDACBER @DrWoodcockFDA

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Kim French

@kimfrench0405

2 years

I just want to wrap my kids in a hug and tell them it’s going to be ok. #ENDALS

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Kim French

@kimfrench0405

4 years

@SteveFDA When will see what else you and @US_FDA have been working on? #NurOwn

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Kim French

@kimfrench0405

1 year

@DrCaliff_FDA #ALS is not rare, we don’t have time to wait. We need accelerated approval now. We are fighting like hell and begging for our lives. #ENDALS

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Kim French

@kimfrench0405

5 years

Who is held accountable when ALS patients are dying everyday while #NurOwn is stalled in an inhumane double blind placebo phase III trial?

FDA Commissioner

@FDACommissioner

5 years

Today, @TheJusticeDept helped FDA take action against two drug, dietary supplement, and device distributors for violating federal law and putting consumer health at risk.