Boom U.S. FDA

squidney Your letter was important and Bobby's story will be told again. I promise. It's inhumane that this drug worked on some in 2015 but our broken ALSFRS doesnt measure things properly so they trust inaccurate data over actual human testimony. #NurOwnWorks.

To live in the #ALS world is one of grief. Each loss has an impact. Each loss takes a toll. So we must never do is take the deep loss of another and make ourselves the focus of that attention. Their lives, the lives of those left behind deserve that dignity and respect. 🌼

I am a board-certified anesthesiologist and pain management physician with ALS. I'm so tired of people talking about NurOwn data without understanding the trial when their lack of understanding is killing me, thousands of my friends, and their children. 1. ALS endpoints are

Please read this Senator Amy Klobuchar

It's MADNESS if anyone is quiet expecting the corrupt FDA Biologics to do the right thing for Nurown. This is still true today as we ALL die WITHOUT HOPE. #NurownWorks #NurownIsSafe #CriticalUnmetNeed

The CRUEL continued FDA Biologics regulatory RIGIDITY for safe & effective #Nurown has a devastating impact that goes far beyond the current generation of hopeless #ALS patients. The massive Pharma investments for oncology treatments are due to the large number battling cancer each

I am with you, Sandra, Brian & the rest of the community who would like to have the opportunity to try BrainstormHQ’s #NurOwn.We need approval for a phase 4 trial.

U.S. FDA FDA Biologics Why not give #NurOwn a chance?! ALS patients living with a 100% fatal disease have nothing more to lose! BrainStorm presented the benefit-risk profile for #NurOwn as positive, asserting the totality of the evidence shows the treatment “has a consistent and

We are with you Sandra Abrevaya. If you don’t have ALS, stay the hell out of this debate. We are one of the few who can say that Eric had NurOwn in his body. He wants & needs more. Let that be his choice, not yours. Until you’re dying, we don’t wanna hear from you. Just stop.

.Senator Amy Klobuchar Tina Smith Here’s more. 👇Dr. Robert M. Califf

.FDA Biologics disregarded the FDA's own Guidance, criticizing Brainstorm for a "large amount of missing data, 50 or more, at week 20 for all biomarkers." I'm an anesthesiologist dying of ALS. ALS weakens and then paralyzes muscles involved in breathing & swallowing. The missing

I can't believe this! It's so frustrating! I specifically explained the ALSFRS-R in my #NurOwn #AdCom statement! Do they even read what we have to say? #ALS #ALSadvocate #NurOwnworks

Another example of inequities in NurOwn AdCom? 🔹Mischaracterization of "missing data" 🔹Pandemic affected collection of CSF at ONE visit to protect patients' health Perspective: This was 1st #ALS trial that collected CSF at multiple times throughout the trial -- more than

CONGRESS & Dr. Robert M. Califf, ENT surgeon, Dr. Randall Latorre, PLEADING for #Nurown approval directly to Peter Marks FDA Biologics IN 2019 #ALS patient - FDA meeting He died of 100% FATAL #ALS 8 months later leaving behind his wife & 3 young children, despite witnessing MANY with

Brainstorm will UNBLIND the trial participants in the #NurOwn P3 trial. Thank you BrainStorm We know #NurOwnWorks & we will always continue to fight for the THOUSANDS who deserve access to the 1st disease-modifying therapy in sporadic #ALS. Note: pursuant to HIPAA

The ALS community never learns. History keeps repeating itself as every new generation thinks passive advocacy & useless U.S. FDA meetings filled with lies & broken promises will succeed. Our endless suffering & dying will forever go on if we don't collectively get really angry

CONGRESS, Dr. Robert M. Califf, FDA Biologics, BrainStorm, & the #ALS community NOW & FUTURE DIAGNOSED: Below are the UNFILTERED thoughts of a dying man. Undoubtedly, October 18th, 2023 will be looked back upon as the darkest day in #ALS history. Even the vast majority of patients

Yyyyy