Viola Serena

als

[Troy Fields @Troy_W_Fields]

The average @FDACBER employee will:
scratch 97 times in a day
speak 140 words per minute
take 3,000 steps per day
live to 77 years.
People #LIVINGwithALS lose the ability to scratch, talk, speak and live. #NurOwn is our best hope to have what they already have. AdComm NOW!

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

Q: Why are people like Josh, Matt & Eric still walking 4 yrs after #ALS onset?

A: They are #LivingProof that #NurOwnWorks
#NurOwn slowed or halted paralysis in some, preserving the neurons' connection to 200 muscles

@FDACBER let them share their 'good evidence'
#NoAdComNoVoice

[BioSpace @biospace]

@BrainstormCell Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in #ALS.
#BrainStormCellTherapeutics #Biotech #BioSpace
https://t.co/CPo3LJuTEn

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

Important for @US_FDA to allow due process & AdCom for #NurOwn so all data can be shared & scientifically debated

~@nicolecimbura in @biospace
Husband's story featured in @noc_film documentary re fight for #ALS drugs

#NoOrdinaryCampaign
#NoAdComNoVoice

@katiecouric @bsw5020

[No More Excuses ALS Watchdogs! @als_now]

#ALS patients have a short time left to join the push to help avert one of the biggest mistakes in #ALS' history. Since #NurOwnworks, its loss would set ALS HOPE back a decade! ➡️ Join the #NurOwn fight. Ask @FDACBER to honor your right to speak! This is it, pALS. #NoAdComNoVoice

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

No one expects cancer Rx to work same on stage 4 vs stage 1 cancer patients

Yet FDA issued RTF letter bc data≠primary endpt when it included most progressed patients of <26

Yet #NurOwn = clinically & statistically meaningful impact on people 26+

#NoAdComNoVoice
#SomeIsEnough

[Shelly Goettl @GoettlShelly]

@aVoice4ALS @HopOnACure @CBSMornings @stevens_nation @klink52 @Smithstrongmom1 @pjgreen @ThurmanTough @kandysimons Roberto Muggli showed small improvements with each NurOwn treatment. Still breathing on his own after 5 1/2 years. We know NurOwn works. It needs to be available to the newly diagnosed as soon as possible to prevent progression.

[Shah Minokadeh, M.D. @MinoShah]

.@US_FDA regulatory rigidity, for 100% fatal #ALS since 1869, left Sarah to die without a chance at survival.

The #ALS community needs Congress to tell @DrCaliff_FDA & his @FDACBER to review the BLA for safe/effective #Nurown and approve NOW for 100% fatal ALS. #ApproveNurown

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

Dear @US_FDA
Some kids have posters on their walls.
This 6 yr old has a memoriam.

This family has lost 33 people to #ALS. You have power to make sure she & her mom aren't next. Please use regulatory flexibility for this most heinous of diseases.

No more #DyingWaiting
#ENDALS

[BrainStorm @BrainstormCell]

People living with #ALS do not have time to wait. We owe it to the ALS Community to do everything in our power to provide access to promising therapies as quickly as possible. The ALS clock waits for no one. end/

[BrainStorm @BrainstormCell]

We support open and transparent scientific discourse regarding the data. We believe that the voice of the entire #ALS community deserves to be heard. 7/

[BrainStorm @BrainstormCell]

We remain committed to working with FDA to deliver treatment to patients. An FDA Advisory Committee Meeting would be an important part of that process, and give NurOwn the fair and open hearing it deserves 6/

[BrainStorm @BrainstormCell]

NurOwn’s potential is demonstrated by numerous data points and supported by recognized and respected experts who have analyzed the data. We believe that #NurOwn is a potential solution for people fighting #ALS 5/

[BrainStorm @BrainstormCell]

Biomarker analyses from NurOwn’s Phase 3 ALS trial presented at the 5th Annual ALS ONE Research Symposium confirmed the importance of accounting for ALSFRS-R floor effects when evaluating clinical endpoints.4/ https://t.co/cj6tWc6c6n

[BrainStorm @BrainstormCell]

Additional analyses from NurOwn’s Phase 3 ALS trial that account for measurement limitations in the lower part of the Revised ALS Functional Rating Scale (ALSFRS-R) were presented at the 21st Annual NEALS Meeting. 3/ https://t.co/QZnGpZ2PlI

[BrainStorm @BrainstormCell]

We stand behind our view that the totality of evidence from NurOwn’s clinical studies, the full dataset and careful analysis of NurOwn’s Phase 3 trial demonstrates the potential for #NurOwn as a treatment for ALS. 2/

[BrainStorm @BrainstormCell]

Today, we shared additional information about the FDA Refusal to File regarding our BLA submission for #NurOwn. We plan to proceed with a Type A meeting. We believe that an FDA Advisory Committee meeting to discuss NurOwn is a critical part of the regulatory process. 1/🧵

[JamieRoseBerryy @JamieRoseBerryy]

I made this video for #MothersDay 2021, to remind @FDACBER that Data=Real people. How naïve of me….

With #ALS , an entire Family WILL suffer, hopeless-as a loved one is tortured to death.

#NurOwn is #Hope

ALS is Life-ending… a glimmer
of Hope is Life-Changing.

#EndALS

[AZ Latina ☮️🌊🟦 @aVoice4ALS]

Incredible tribute from one bad a** woman about the advocacy & legacy of another bad a** woman, @JamieRoseBerryy. Together they are changing the future of #ALS.

#JamiesVoice

[TheRealCathyS @CathyStandish]

“The tears of the #ALS world are a constant quantity.”

Remembering Jamie, Derek, Catherine, Alyssa and Pete.

#SundayMorning #sundayvibes #EndALS