I made this video for #MothersDay 2021, to remind FDA Biologics 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

.U.S. 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 Dr. Robert M. Califf & his FDA Biologics to review the BLA for safe/effective #Nurown and approve NOW for 100% fatal ALS. #ApproveNurown

AZ Latina ☮️🌊🟦 HopOnACure CBS Mornings axeALSFoundation Mitze Klingenberg BSN, RN Smithstrongmom Phil Green @ThurmanTough Kandy Simons 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.

“The tears of the #ALS world are a constant quantity.” Remembering Jamie, Derek, Catherine, Alyssa and Pete. #SundayMorning #sundayvibes #EndALS

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

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/🧵

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/

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/ bit.ly/3X4Jl0a

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/ bit.ly/3X49mfN

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/

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/

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/

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/

Dear U.S. 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

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

#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 FDA Biologics to honor your right to speak! This is it, pALS. #NoAdComNoVoice

BrainStorm Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in #ALS. #BrainStormCellTherapeutics #Biotech #BioSpace hubs.li/Q01scvxK0

Important for U.S. FDA to allow due process & AdCom for #NurOwn so all data can be shared & scientifically debated ~Nicole Cimbura in BioSpace Husband's story featured in No Ordinary Campaign documentary re fight for #ALS drugs #NoOrdinaryCampaign #NoAdComNoVoice Katie Couric Brian Wallach

The average FDA Biologics 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!

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 FDA Biologics let them share their 'good evidence' #NoAdComNoVoice