Smithstrongmom (@smithstrongmom1) 's Twitter Profile
Smithstrongmom

@smithstrongmom1

Fighting for my son with ALS

ID: 1249428246501810176

calendar_today12-04-2020 20:04:56

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AZ Latina ☮️🌊🟦 (@avoice4als) 's Twitter Profile Photo

To all my Mama Bear friends whose kids are fighting #ALS: I'm not sure where you get your strength amidst your grief & anger. Your child's life matters. You deserve a right to be heard. We will fight without remorse until our govt listens. President Donald J. Trump First Lady Melania Trump #motherslove

To all my Mama Bear friends whose kids are fighting #ALS: I'm not sure where you get your strength amidst your grief & anger. 

Your child's life matters.
You deserve a right to be heard.
We will fight without remorse until our govt listens.

<a href="/POTUS/">President Donald J. Trump</a> <a href="/FLOTUS/">First Lady Melania Trump</a>

#motherslove
Shah Minokadeh, M.D. (@minoshah) 's Twitter Profile Photo

I am dying of #ALS WITH NO CHANCE OF SURVIVAL after being diagnosed at 35 years old, I have been left to die denied #NUROWN due to the CRUEL FDA Biologics regulatory RIGIDITY for 100% FATAL ALS, despite witnessing YEARS of UNPRECEDENTED #RealWorldEvidence of efficacy. Dr. Robert M. Califf,

I am dying of #ALS WITH NO CHANCE OF SURVIVAL after being diagnosed at 35 years old,

I have been left to die denied #NUROWN due to the CRUEL <a href="/FDACBER/">FDA Biologics</a> regulatory RIGIDITY for 100% FATAL ALS, despite witnessing YEARS of UNPRECEDENTED #RealWorldEvidence of efficacy.

<a href="/DrCaliff_FDA/">Dr. Robert M. Califf</a>,
AZ Latina ☮️🌊🟦 (@avoice4als) 's Twitter Profile Photo

June 2019-23: 🔹Josh declined from a 40 to a 33 🔹7-point loss in 48 mos = 0.15 pts/mo #NurOwn halted his progression when he got it & drastically slowed his #ALS decline overall Believe his #RWD #NurOwnWorks regulations.gov/comment/FDA-20… Dr. Robert M. Califf FDA Biologics Neera Tanden🌻

June 2019-23:
🔹Josh declined from a 40 to a 33
🔹7-point loss in 48 mos  = 0.15 pts/mo

#NurOwn halted his progression when he got it &amp; drastically slowed his #ALS decline overall

Believe his #RWD 
#NurOwnWorks 

regulations.gov/comment/FDA-20…

<a href="/DrCaliff_FDA/">Dr. Robert M. Califf</a> <a href="/FDACBER/">FDA Biologics</a> <a href="/neeratanden/">Neera Tanden🌻</a>
Shah Minokadeh, M.D. (@minoshah) 's Twitter Profile Photo

36-year-old Eddie died of #ALS WITH NO CHANCE OF SURVIVAL >90% of people with HORRIFIC 100% FATAL #ALS have no family history. You or your loved one could be next CONGRESS, DEMAND an END to the CRUEL FDA Biologics regulatory RIGIDITY. Dr. Robert M. Califf, grant #NUROWN Accelerated

36-year-old Eddie died of #ALS WITH NO CHANCE OF SURVIVAL

&gt;90% of people with HORRIFIC 100% FATAL #ALS have no family history.
You or your loved one could be next

CONGRESS, DEMAND an END to the CRUEL <a href="/FDACBER/">FDA Biologics</a> regulatory RIGIDITY.
<a href="/DrCaliff_FDA/">Dr. Robert M. Califf</a>, grant #NUROWN Accelerated
AZ Latina ☮️🌊🟦 (@avoice4als) 's Twitter Profile Photo

P2 #NurOwn trial in 2015 🔹15 mos after 1 dose, Terri lost 1 pt every 4 mos instead of avg 1 pt/mo 🔹8 yrs after NurOwn, despite having bulbar onset, Terri is still speaking, eating & only using bipap at night That's why she has HOPE #NurOwnWorks #RWD regulations.gov/comment/FDA-20…

P2 #NurOwn trial in 2015

🔹15 mos after 1 dose, Terri lost 1 pt every 4 mos instead of avg 1 pt/mo

🔹8 yrs after NurOwn, despite having bulbar onset, Terri is still speaking, eating &amp; only using bipap at night

That's why she has HOPE
#NurOwnWorks #RWD

regulations.gov/comment/FDA-20…
Lorri Cavaliere (@lorricav) 's Twitter Profile Photo

Obstetric anesthesiologist, Dr. Stacy Lewin’s statement to the FDA Biologics in the fight for her life. regulations.gov/comment/FDA-20… Diagnosed in 2021. Please hear her pleas. She needs #NurOwnNow to help her in battle with #ALS.

Obstetric anesthesiologist, Dr. Stacy Lewin’s statement to the <a href="/FDACBER/">FDA Biologics</a> in the fight for her life. regulations.gov/comment/FDA-20… Diagnosed in 2021. Please hear her pleas. She needs #NurOwnNow to help her in battle with #ALS.
ALS ACCESS (@brainmatters10) 's Twitter Profile Photo

Guide to Submitting Written Testimony to the FDA about NurOwn iamals.org/updates/guide-… Bart Baker Muscular Dystrophy Association @PMelmeyer @alsagoldenwest @ALSphiladelphia Please write a comment in this document. It is crucial

Nicole Cimbura (@nicolecimbura) 's Twitter Profile Photo

Thanks Mark bedwell AlS for showing us what Matthew Bellina could do after receiving #NurOwn from BrainStorm through RTT. Matt received 7 doses of the therapy. Upon his first dosing his ALSFRS-R score was a 21 a year later he was at a 27. This 6 point gain is HUGE!

AZ Latina ☮️🌊🟦 (@avoice4als) 's Twitter Profile Photo

"If #NurOwn were an option, the world would have his data & he’d have gladly paid for the possibility of contributing it to a knowledge base that someday will help others survive where he could not... now his data is gone" regulations.gov/comment/FDA-20… FDA Biologics Dr. Robert M. Califf #ALS

"If #NurOwn were an option, the world would have his data &amp; he’d have gladly paid for the possibility of contributing it to a knowledge base that someday will help others survive where he could not... now his data is gone"

regulations.gov/comment/FDA-20…

<a href="/FDACBER/">FDA Biologics</a> <a href="/DrCaliff_FDA/">Dr. Robert M. Califf</a>
#ALS
AZ Latina ☮️🌊🟦 (@avoice4als) 's Twitter Profile Photo

Thx FDA for exercising regulatory flexibility w post hoc data & trusting patients to assess risks themselves. "Patients know it’s not a cure, but it’s something to slow it down... so that they can enjoy the life that they have” FDA Biologics Please do same for #NurOwn in #ALS

Thx <a href="/FDA/">FDA</a> for exercising regulatory flexibility w post hoc data &amp; trusting patients to assess risks themselves.

"Patients know it’s not a cure, but it’s something to slow it down...  so that they can enjoy the life that they have”

<a href="/FDACBER/">FDA Biologics</a> Please do same for #NurOwn in #ALS
Phil Green (@pjgreen) 's Twitter Profile Photo

5 years ago today, I was diagnosed with #ALS. I haven’t walked in years but I am still breathing on my own and eating whatever I want. I attribute much of what I can still do today to the six treatments of #NurOwn that I received under EAP.

Nicole Cimbura (@nicolecimbura) 's Twitter Profile Photo

Dear U.S. FDA please take into account this evidence in reviewing #NurOwn "Progression slowed down and improved function" Smithstrongmom #EveryPointMatters #NurOwnWorks

Dear <a href="/US_FDA/">U.S. FDA</a> please take into account this evidence in reviewing #NurOwn "Progression slowed down and improved function"  <a href="/Smithstrongmom1/">Smithstrongmom</a> #EveryPointMatters #NurOwnWorks
Nicole Cimbura (@nicolecimbura) 's Twitter Profile Photo

"We must work quickly to save the next ALS vintage & possibly some of us from this one. Please hurry! The waiting is deadly." Sandy Morris Thank you, Joe, for your testimony for today's # NurOwn's ad comm; it was so powerful. 🌻🌻🌻 #NurOwnWorks #EveryPointMatters

"We must work quickly to save the next ALS vintage &amp; possibly some of us from this one. Please hurry! The waiting is deadly." <a href="/sandymorris333/">Sandy Morris</a> Thank you, Joe, for your testimony for today's # NurOwn's ad comm; it was so powerful. 🌻🌻🌻 #NurOwnWorks #EveryPointMatters
Nicole Cimbura (@nicolecimbura) 's Twitter Profile Photo

Thank you, axeALSFoundation, for speaking out today regarding Eric's experience with #NurOwn stating that "Without NurOwn, he has declined" and "NurOwn enhances his quality of life."

Thank you, <a href="/stevens_nation/">axeALSFoundation</a>, for speaking out today regarding Eric's experience with #NurOwn stating that "Without NurOwn, he has declined" and "NurOwn enhances his quality of life."
AZ Latina ☮️🌊🟦 (@avoice4als) 's Twitter Profile Photo

ALS Uncensored 🏴‍☠️ The #NurOwn AdCom on Sept 27th was like: Russian trial of an American citizen... Then Pharma media was like Russian TV reporting on the Ukraine War. Pharma media has NOT done Due Diligence. They: 🔹Don't understand #ALS 🔹Don't understand flawed subjective tool used for

<a href="/ScottsFight/">ALS Uncensored 🏴‍☠️</a> The #NurOwn AdCom on Sept 27th was like: 

Russian trial of an American citizen...  Then 
Pharma media was like Russian TV reporting on the Ukraine War.

Pharma media has NOT done Due Diligence. They: 
🔹Don't understand #ALS
🔹Don't understand flawed subjective tool used for