If you have not seen it yet, BrainStorm issued a press release early this morning: https://ir.brainstorm-cell.com/2023-10-18-BrainStorm-Cell-Therapeutics-to-Meet-with-US-FDA-to-Discuss-Development-Plan-for-NurOwn-as-a-Treatment-of-ALS

We are disappointed to learn that BrainStorm withdrew its FDA Biologics License Application for NurOwn. This means that December 8, 2023 is no longer the designated PDUFA date. Our hearts go out to the people living with ALS who will now have further delayed access to NurOwn. In reality, some people won’t see NurOwn’s approval. I AM ALS’s community support team has support groups to help you during this difficult time.

We are disappointed that we learned this news only a few hours before their meeting. The ALS community deserves better than this. We also knew BrainStorm’s initial trial design was not ideal. It received a 1/5 stars on the Patient-centric Clinical Trial Design (PaCTD) Rating System. We look forward to working with BrainStorm, the FDA, and people living with ALS to ensure their next study is transparent, fast, and has strong confirmatory science to receive a 5/5 on the PaCTD Rating System. All things the initial study lacked.