Expanded Access Policy

Nuevocor is dedicated to developing transformative genetic medicines for patients affected by rare cardiomyopathies. To that end, we work closely with key stakeholders, including the patient community and advocacy organizations, physicians and healthcare providers, and global regulatory agencies. We are committed to conducting a rigorous clinical development process and upholding high ethical standards to evaluate the safety and efficacy of our investigational gene therapy products.

 

Currently, Nuevocor is focused on conducting clinical studies to obtain regulatory approval so that these potentially transformative therapies may be made available to patients as soon as feasible. Unfortunately, situations arise when a patient with a serious or life-threatening disease does not qualify for a clinical trial. Patients may then seek access to the investigational product outside of a clinical trial and prior to regulatory approval, a pathway known as Expanded Access. Nuevocor has carefully considered its policy regarding Expanded Access, taking into account the potential risks and benefits to patients, the need to generate robust clinical evidence, and other ethical and scientific considerations.

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At this stage of clinical development, our investigational products are in the early stages of evaluation for safety and efficacy. Therefore, access to these therapies is possible only through participation in our clinical studies. Nuevocor does not currently offer an Expanded Access Program for any of its investigational products. We will continue to periodically re-evaluate this policy as our development programs advance. In the meantime, we strongly encourage patients to discuss all available treatment options with their physicians, including participation in relevant clinical trials that may provide access to investigational therapies.

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If you are a patient, family member, or healthcare provider and have questions about this policy, please contact us at info@nuevocor.com.  

 

Further information on available clinical trials can be found on our website at www.nuevocor.com or on the U.S. National Library of Medicine’s clinical trials registry at www.clinicaltrials.gov.

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Nuevocor reserves the right to revise this policy at any time, in accordance with applicable laws and regulations, including the 21st Century Cures Act.