NurOwn AdComm Watch Event

On September 27, 2023, join ALS community members watching the U.S. Food and Drug Administration’s (FDA) AdComm on BrainStorm’s NurOwn. Sign up by filling out this form.

Now what’s an AdComm?

Good question. AdComm is short for Advisory Committee.

These are panels of outside experts that provide advice to FDA, which can be made up of physician-researchers, clinicians, statisticians, community, and consumer representatives. AdComms give recommendations and/or answer questions posed by FDA after they meet and review available evidence, written testimony, and hear oral testimony from impacted parties

We are hopeful that the AdComm will recommend FDA approval of NurOwn.

The AdComm will NOT decide whether NurOwn will be approved. The final decision rests with the FDA. The deadline for the FDA’s approval decision (the “PDUFA” date) is December 8th, 2023.

When is the AdComm?

The AdComm is on September 27, 2023 (Wednesday) from 10 am to 6 pm ET. The tentative schedule for the full day’s events is (this will be updated as we receive more information):

• 10 am – Call to Order
• 6 pm. – Adjournment

For more information on the Advisory committee, please visit:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-september-27-2023-meeting-announcement#event-materials

For more information on NurOwn, please visit:

https://brainstorm-cell.com/pipeline/#phase-2-results