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|BrainStorm Provides Update on "Right to Try" Policy|
Webcast and Conference Call at
Brainstorm has carefully evaluated the ethical, legal and practical aspects of the newly enacted RTT legislation in detail, and has received detailed feedback from patients, clinicians, regulatory and legal experts. The company has established an ethical and practical framework with four key elements that must be satisfied in order to be able to provide NurOwn® to ALS patients under the RTT pathway. The four elements are: providing the treatment to a limited number of patients at clinical trial-experienced sites to ensure the necessary expertise and systems of care are in place to safely and effectively deliver the therapy; ensuring that patients are fully educated on the benefits and risks of the investigational therapy; limiting the inclusion to patients who do not meet the Phase 3 clinical trial inclusion criteria to ensure that the RTT pathway does not adversely impact the clinical trial; and lastly, finding alternative funding solutions for patients who are unable to afford the high cost of regenerative medicine cell therapies. The company has found practical solutions for all except the funding issue and, as a consequence, is unable to initiate the provision of NurOwn® under the RTT pathway until all elements are fully satisfied.
"We feel a tremendous sense of urgency and responsibility to provide an ethical, compassionate, and well-reasoned practical response to the demand for NurOwn® and have worked tirelessly with patients and other stakeholders to find a solution," said
Webcast and Conference Call,
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause
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