BrainStorm Announces Plans For Dosing Extension Of NurOwn - Quick Facts

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) said the FDA recommended that the company submit an EAP protocol amendment to provide additional dosing of NurOwn for participants who completed the Expanded Access Protocol. Under the amended EAP protocol, eligible participants will receive up to 3 additional doses.

The NurOwn Expanded Access Protocol was established in 2020, following conclusion of the phase 3 trial, and the protocol was developed in partnership with the FDA.

Chaim Lebovits, CEO, Brainstorm, said, "We look forward to continuing this dialogue with the FDA for the best path forward."