Expanded Access Policy*

Poseida is committed to developing safe and effective therapies for patients and strives to put patients first.

Expanded access, also referred to as compassionate use, refers to the use of an investigational therapy outside of a clinical trial for the potential treatment of a serious or immediately life-threatening condition in absence of comparable or satisfactory alternative treatment options. Currently, Poseida does not have any ongoing Expanded Access protocols, nor do we offer access to our investigational products through individual Expanded Access.

Poseida’s innovative therapies are considered investigational as they have not yet been approved by regulatory authorities, such as the U.S. Food and Drug Administration (FDA). Our goal is to provide best-in-class CAR-T therapies and gene therapies to patients as soon as possible through efficient drug development and patient accessibility. We are focused on conducting the clinical trials necessary to apply for regulatory approvals to make our investigational therapies broadly available to patients. As such, currently participating in one of our clinical trials is the most appropriate way for potential patients to access our investigational therapies. 

Patients are encouraged to learn about our clinical trials on our website or clinicaltrials.gov.

Reference:

*EAP – Pursuant to section 561A(f)(2) of the United States Food, Drug, and Cosmetics Act

We don’t have an active Expanded Access Program (EAP) right now to provide access to our investigational therapies on an expanded access basis. The Company believes that the best way to develop therapies is to conduct rigorous clinical development trials. Participation in one of the clinical trials is the best and preferred route to access investigational therapies. Patients are encouraged to learn more about our clinical trials on our website or clinicaltrials.gov.