BrainStorm says currently assessing ‘Right-To-Try’ legislation

BrainStorm Cell Therapeutics issues a statement following Congress passing the Federal “Right-to-Try” bill. The “Right-to-Try” bill will enable terminally ill patients who do not meet clinical trial criteria to seek out experimental therapies that do not yet have approval by the US Food and Drug Administration. Chaim Lebovits, president and CEO, said,”BrainStorm understands the serious unmet medical need and urgency of people living with ALS. We have received countless inquiries after the passing of Federal ‘Right-to-Try’ legislation about patient access to NurOwn. We have been, and will continue to, be engaged and collaborate with people with ALS, their families and caregivers, and legislators and government agencies to ensure that the voices of these groups are heard in this important discussion. Brainstorm is currently assessing the legislation and its potential implications, and when signed into law, will issue a formal policy on ‘Right-to-Try’ in early June. BrainStorm remains focused and fully committed to completing the Phase 3 clinical trial of NurOwn as quickly as possible. While we continually evaluate ways to provide access to NurOwn outside of the current Phase 3 trial to the many patients who can’t wait, the most expedient way to make NurOwn available to all is by completing the necessary clinical trial data collection and endpoint analyses, and submitting the required marketing applications without delay to regulatory agencies, including the FDA.”

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