READ THE PETITION
The NurOwn Citizens' Petition is a community-led effort seeking approval of and access to BrainStorm Cell Therapeutics' NurOwn. This community is asking the FDA to review the totality of evidence and take into account the significant patient experiences and deliver a life-changing approval for ALS patients. The Citizens' Petition asks the FDA to grant accelerated approval of NurOwn with mandatory participation in a broad Phase 4 clinical trial to verify and describe the treatment’s clinical benefit.
PETITION HIGHLIGHTS
Patients who received NurOwn live longer and live better!
As described in the petition, the ALS community recognized 6 critical points from the unprecedented EAP data.
01
Comparison to approved therapies.
NurOwn EAP survival data exceeds survival data of approved cancer therapies.
04
Slowed progression.
85% slowing in rate of progression compared to natural ALS history (=0.15pts/month on ALSFRS-R).
02
Trach-free survival.
NurOwn patients experiences 2x-3x longer trach-free survival vs. the 30 month median of natural ALS history.
05
Progression-free survival.
Unblinded real-world evidence and patient experiences confirm halted progression with NurOwn. In cancer terms, extended time of "progression-free survival."
03
5 year survival.
100% of NurOwn EAP patients achieved 5 years of survival vs. 20% of patients of natural ALS history.
06
NIV-Free Survival.
4x-7x longer time-to-NIV (60-103 months) compared to natural ALS history (15 months).
ALS BY THE NUMBERS
100%
Fatality rate associated with an ALS diagnosis.
90
Someone is diagnosed with and someone dies from ALS approximately every 90 minutes.
30,000
Patients living with ALS in the United States.
90%
90% of ALS cases are sporadic, meaning there is no known cause.
2-5
Average amount of years survived after ALS diagnosis.
10%
10% of ALS cases are familial, meaning there is a genetic cause for the disease.