LogicBio Expanded Access Policy
At LogicBio, we are steadfast in our mission to deliver the hope of genetic medicine to patients with rare diseases. We understand the serious nature of the diseases we are seeking to treat and we recognize the urgency to improve upon the current standards of care. We believe that the most responsible way to succeed in our goal is to focus on a rigorous clinical research process for our investigational therapies in collaboration with health care professionals, advocacy organizations, and regulatory agencies. Please find information about our expanded access policy below.
Expanded Access Policy: LogicBio is currently unable to provide access to its investigational medicines outside of clinical trials. This decision is due to our stage of development- we are in the beginning phases of evaluating the safety and effectiveness of hLB-001. We must also balance product inventory, manufacturing capacity, and other considerations when making treatment access decisions. Information about our current clinical studies, the primary mechanism to access our investigational therapies can be found by visiting clinicaltrials.gov.
Contact Information: A treating physician may submit questions or requests regarding Expanded Access by contacting LogicBio at firstname.lastname@example.org If you are a patient or family member with specific expanded access questions, please discuss those with your treating physician who can contact LogicBio on your or your loved one’s behalf. All other patient inquiries should be directed to email@example.com
Anticipated Timing: LogicBio will acknowledge receipt of any Expanded Access questions or requests from licensed physicians within seven (7) business days of receipt. Making a request does not guarantee the granting of access to an investigational drug by LogicBio.
In accordance with the 21st Century Cures Act, LogicBio may revise this posted expanded access policy at any time.