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- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
This would be a great way to start #2022 @Cylebo @BrainstormCell @US_FDA @califf001 The #ALS community needs #NurOwn in the fight against this devastating disease. (Twitter) - Dec 25, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical, Heterogeneity: 10/ Vastly heterogeneous #ALS needs @FDACBER to exercise reg flexibility re #NurOwn ▪️ Objective biomarker data re neuro-inflammation, degeneration & protection ▪️ Clinically meaningful changes in speed of decline ▪️ PROs show "some" regained funxn @SecBecerra @califf001 (Twitter) - Dec 25, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical, Patient reported outcomes: 9/ Clinical & biological proof to support #PatientReportedOutcomes on #NurOwn since 2015 #NurOwnWorked then #NurOwnWorks now Since 2015, we've lost 40k+ Americans to #ALS #ALSclock is ticking People are #DyingWaiting #SomeisEnough @SecBecerra @califf001 #AcceleratedApproval (Twitter) - Dec 25, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: 8/ SECONDARY ENDPOINT = Change from Baseline ALSFRS Difference of those on #NurOwn vs placebo was 2+ pts less decline -- which is clinically meaningful. At 34+, it was 2.74 point less decline Ask an #ALS patient what it means to lose 2 -3 less pts in half a year! #NurOwnWorks (Twitter) - Dec 25, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical, Heterogeneity: 6/ PRIMARY ENDPOINT In Patients w #ALS of 26+ on 48 pt ALSFRS, appx 35% slowed progression & proved #NurOwnWorks in vastly heterogeneous disease At 26, p-value was fractions away from stat significance. 27 met .05 @BrainstormCell #FileTheBLA for #NurOwn https://t.co/FXd51kGct8 (Twitter) - Dec 25, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: 5/ Clinically meaningful changes in @MuscleandNerve study: #NurOwn trial's primary endpoint was whether patients prespecified 35 ALSFRS had slower rate of decline by -1.25 pts/mo Data of 35+ showed #NurOwnWorks but sample size was too small to reach statistical significance. (Twitter) - Dec 25, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical: 4/ Dozen CSF #biomarkers showed improvmts after just 3 doses of #NurOwn over 28 wk trial Note drastic ⬆️ in neuroprotection that correlates w PROs of newly dx'd patients who REGAINED FUNCTION for 1st time in #ALS history. Others slowed decline #AcceleratedApproval @SecBecerra (Twitter) - Dec 25, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical: 3/ #Biomarker data supports #AcceleratedApproval of #NurOwn. Dr Bob Brown of UMass is most prolific #ALS researcher in world w 300+ peer-reviewed studies. ▪️"robust & significant CSF biomarker" data ▪️100% people on NurOwn & 0% on placebo ▪️ 82.5% correlation w responders (Twitter) - Dec 25, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: 2/ Top #ALS PIs believe #NurOwnWorks: ▪️ Merit Cudkowicz (MassGen) -"both biological & clinical signals of a treatment effect" ▪️ Bob Brown (UMass) - "exceptional" # had "very dramatic response" ▪️ Tony Windebank (MAYO) -"clear signal that some patients" responded to #NurOwn (Twitter) - Dec 25, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical, Patient reported outcomes: 1/ Hopeful @califf001 & @FDACBER will look at Totality of Evidence & show reg flexibility promised in #ALS GuidanceDoc @BrainstormCell study in @MuscleAndNerve proves #NurOwn works ▪️ Expert Neuro PIs ▪️ Biomarkers ▪️ Clinically meaningful changes ▪️ Patient Reported Outcomes (Twitter) - Dec 25, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
P4 data: We stand ready to fight with you for #Nurown approval and other promising treatments for ALS. Consider filing the BLA and approval conditional on a Phase 4 post marketing study if offered by @US_FDA @califf001 (Twitter) - Dec 24, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
. @BrainstormCell @US_FDA @FDACBER @HHSGov @califf001 @DrWoodcockFDA @iamalsorg @als_now @alsassociation #Nurown #NurownNow #NurownWorks #DyingWaiting #ALS (Twitter) - Dec 23, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: The past: ALS exists for over 150 years with no viable treatments or cure. The future: #NurOwn is approved, ALS patients have early access to treatments in clinical trials, symptoms are reversed, and it becomes a liveable disease. (Twitter) - Dec 22, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
People living with ALS are dying waiting for @US_FDA to listen to our voices @peterpitts @califf001 #ALS took my running legs but #NurOwn gave me time with family and hope. Cheering from the sidelines is better than the alternative.#LivingProof #FileTheBLA #AcceleratedApproval https://t.co/nM2Op984PT (Twitter) - Dec 22, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
P3 data: My son improved twice on #NurOwn. In Phase 3 and in EAP. He needs it now! This is him 3 yrs into diagnosis. Almost 4 yrs after symptom onset. #Livingproof #FileTheBLA #NurOwnWorks #AcceleratedApproval (Twitter) - Dec 22, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical, Review, Patient reported outcomes: Great article @PeterPitts Hopeful for @califf001 review of #NurOwn w same reg flexibility in #ALS as shown w DMD. @BrainstormCell study in @MuscleAndNerve proves #NurOwnWorked ▪️ Clinically meaningful changes ▪️ Biomarkers ▪️ Expert Witness Neuros ▪️ Patient Reported Outcomes (Twitter) - Dec 21, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
Yep you nailed it- next battle for all of your lives #NurOwn! My husband also wants to see our kids grow up. This is a must win. (Twitter) - Dec 21, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
Please #NurOwn is needed. Expedite it @FDACBER @califf001 @Potus @FLOTUS @BrainstormCell #FiletheBLA (Twitter) - Dec 21, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: Last week after the Senate passed #ACTforALS, I dreamt of watching my kids grow up. The bill will likely not help me on time, but #NurOwn can. NurOwn stopped progression and improved function in some #ALS patients. pALS today want a chance to live. Please help @califf001 @US_FDA! (Twitter) - Dec 21, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
@PatriciaManhar1 and others fighting #ALS deserve the chance to try #NurOwn @BrainstormCell @DrWoodcockFDA @FDACBER @FDACommissioner @califf001 (Twitter) - Dec 21, 2021
- | NurOwn (MSC-NTF) / BrainStorm Cell Therap
@BrainstormCell #filetheBLA @US_FDA here is your proof. #NurOwn works! (Twitter) - Dec 20, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
So sorry this happened to you. @BrainstormCell pls “lift up” Jamie by filing the #NurOwn #BLA. @califf001 @US_FDA @FDACommissioner @FDACBER it’s time. (Twitter) - Dec 20, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
Make #NurOwn trials available in India please. @narendramodi @BrainstormCell #MND #ALS #icebucketchallenge #ACTforALS (Twitter) - Dec 18, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: Woke up with a little pep in my step this morning! I like how #hope feels! #ACTforALS 🚶♂️🚶♂️🚶♂️ Now if we can get #NurOwn to #ALS patients who desperately need it @califf001 @US_FDA @FDACBER @Cylebo ALS patients would love to be alive to see the fruits of ACT for ALS! 🙏🙏🙏 (Twitter) - Dec 17, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
.@BrainstormCell pls file #NurOwn's BLA. @califf001 @US_FDA @FDACommissioner @FDACBER @DrWoodcockFDA please approve #NurOwn. Each snowflake is unique & so is each pALS' battle with ALS. Our friends & family dying from #ALS deserve a chance to try this treatment. ❄️ (Twitter) - Dec 17, 2021
- | NurOwn (MSC-NTF) / BrainStorm Cell Therap
We are all waiting @alsassociation Do the right thing!! Support NurOwn (Twitter) - Dec 15, 2021
- | NurOwn (MSC-NTF) / BrainStorm Cell Therap
@alsassociation never speaks the word #NurOwn Shame on them...they've been so disappointing 😡 (Twitter) - Dec 15, 2021
- | NurOwn (MSC-NTF) / BrainStorm Cell Therap
Agreed. It’s so strange to me that @alsassociation pretends #NurOwn doesn’t exist. (Twitter) - Dec 15, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
Review: How have we not heard from the ALS association in regards to the positive peer review for NurOwn????? (Twitter) - Dec 15, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Now we have Proof Now is the Time People are #DyingWaiting People need #NurOwn @BrainstormCell - #FileTheBLA #NurOwnWorks @FDACBER @US_FDA @califf001 @SecBecerra @WHCOS @RepAnnaEshoo @RepSchakowsky @RepMikeQuigley @RepJasonCrow @SenWhitehouse @ChrisCoons @SenatorBraun (Twitter) - Dec 13, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
My son is 32 and a responder to Nurown! #livingproof #nurownworks #filetheBLA (Twitter) - Dec 13, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
Now we have Proof Now is the Time People are #DyingWaiting People need #NurOwn @BrainstormCell - #FileTheBLA #NurOwnWorks @FDACBER @US_FDA @califf001 @SecBecerra @RepAnnaEshoo @RepSchakowsky @SenWhitehouse @ChrisCoons @SenatorBraun @RepJasonCrow @KenCalvert @RepBrianFitz (Twitter) - Dec 13, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
@FDACBER @califf001 @FDACommissioner @DrWoodcockFDA it's time to use the same regulatory flexibility shown to #AMX0035 to #NurOwn. @BrainstormCell submit the BLA now. People with ALS can't wait. (Twitter) - Dec 13, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Every day 16 people are diagnosed with #ALS. Every day 16 people die of #ALS. The time is NOW to approve #Nurown!!! #dyingwaiting #NurOwnWorks @SenatorLankford @JimInhofe (Twitter) - Dec 13, 2021
- ||| tofersen (BIIB067) / Biogen, NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: I hear you. We're seeing this with genetic forms of ALS. For example, Tofersen is given only to SOD-1 patients. There's so much still to learn about all forms of ALS. We can't dismiss a treatment that works exceedingly well for some patients, like NurOwn, out of ignorance. (Twitter) - Dec 13, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
We need Nurown! My son needs Nurown! @BrainstormCell #FiletheBLA #dyingwaiting #Nurown #NurOwnWorks (Twitter) - Dec 13, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
. #NurOwn works @FDACBER fast track and approve. (Twitter) - Dec 13, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: Thank you @BrainStormcell for staying committed to #ALS patients. Peer Reviewed Study in @MuscleNerve @BrainstormCell shows #NurOwn is effective for #ALS patients with ALSFS above 26. @califf001 @FDACBER should ASAP expedite through accelerated approval. #FileTheBLA! (Twitter) - Dec 13, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: Thank you @BrainStormcell for staying committed to #ALS patients. Peer Reviewed Study in @MuscleNerve @BrainstormCell shows #NurOwn is effective for #ALS patients with ALSFS above 26. @califf001 @FDACBER should ASAP expedite through accelerated approval. #FileTheBLA! (Twitter) - Dec 13, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Now we have Proof Now is the Time People are #DyingWaiting People need #NurOwn @BrainstormCell - #FileTheBLA #NurOwnWorks @FDACBER @US_FDA @califf001 @SecBecerra @RepAnnaEshoo @RepSchakowsky @SenWhitehouse @ChrisCoons @SenatorBraun @RepJasonCrow @KenCalvert @RepBrianFitz (Twitter) - Dec 13, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: Peer Reviewed Study in @MuscleNerve @BrainstormCell shows #NurOwn is effective for #ALS patients with ALSFS above 26. @califf001 @FDACBER should ASAP expedite through accelerated approval. #FileTheBLA! (Twitter) - Dec 13, 2021
- |||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Clinical: This further supports what we already knew... #NurownWorks. There is no time to waste @BrainstormCell! #ALS patients are suffering and dying EVERY DAY while denied access to safe/effective #Nurown. #FileTheBLA NOW! @FDACBER @califf001 @Cylebo (Twitter) - Dec 13, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
P3 data: My son is waiting for #NurOwn. He stabalized in Phase 3 and EAP! @endpts @DMRegister @scj @crgazette @US_FDA @FDACBER (Twitter) - Dec 12, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
#NurOwn #NurOwnWorks (Twitter) - Dec 12, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
#NurownWorks -Congress MUST tell @FDACBER to APPROVE SAFE/EFFECTIVE #NUROWN NOW! #EndALS @RepAnnaEshoo @RepSchakowsky @rosadelauro @ChrisCoons @SenJohnThune @RepMullin @SenatorDurbin @SecBecerra @SenatorBraun @cathymcmorris @RepMikeQuigley @brettguthrie @RepJohnCurtis @califf001 (Twitter) - Dec 12, 2021
- | NurOwn (MSC-NTF) / BrainStorm Cell Therap
I can NOT wait to bring my mom to get #NurOwn #ENDALS you guys are amazing!!! (Twitter) - Dec 11, 2021
- | NurOwn (MSC-NTF) / BrainStorm Cell Therap
Pls explain...Is there any hope for approval of nurown (Twitter) - Dec 11, 2021
- ||||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical, Patient reported outcomes: Great news re #NurOwn Presented by Dr. Robert Brown of UMass Compelling Biomarker data show such profound impact across 3 #ALS disease pathways of neuroinflammation, neurodegeneration & neuroprotection Biomarkers confirm #PatientReportedOutcomes @FDACBER @US_FDA @califf001 (Twitter) - Dec 8, 2021
- ||| NurOwn (MSC-NTF) / BrainStorm Cell Therap
Biomarker, Clinical, Real-world evidence: @bsw5020 @amyklobuchar @POTUS @timkaine I’m very hopeful that @califf001 will endorse the real world data & first ever biomarkers for ALS along with @FDACBER. Looking forward to one of the best ALS docs in the world, Dr. Bob Brown speaking to new analysis on #NurOwn tomorrow. (Twitter) - Dec 7, 2021
- || NurOwn (MSC-NTF) / BrainStorm Cell Therap
The ALSA proved in 2017 that they only care about their paychecks and bonuses over pals lives!!! They chose Radacava over Nurown because they wanted the corporate sponsor money!!! Improving pals is bad for their fundraising efforts!!! (Twitter) - Dec 7, 2021