RTT1121 whole psilocybin mushrooms with indication for treating PTSD and demoralization syndrome
SCOTTSDALE RESEARCH INSTITUTE / FIELD TO HEALED FOUNDATION
SINGLE-PATIENT FDA EXPANDED ACCESS POLICIES AND CRITERIA
Purpose. Scottsdale Research Institute/Field To Healed Foundation (SRI/FTHF) is committed to considering requests for FDA Expanded Access to investigational products when a patient has a serious or immediately life-threatening disease or condition, lacks a comparable or satisfactory therapeutic alternative, and access to an investigational product outside a clinical trial may be medically and ethically appropriate. Expanded Access is treatment use of an investigational product and is not a substitute for participation in an appropriate clinical trial when trial participation is reasonably available.
Criteria for Consideration. SRI/FTHF will consider a single-patient Expanded Access request when the treating Investigator determines that the patient has a serious or immediately life-threatening condition; no comparable or satisfactory therapeutic alternative is reasonably available; the patient cannot reasonably obtain the investigational product through an appropriate clinical trial; and the anticipated potential benefit justifies the reasonably foreseeable risks based upon the patient’s medical and psychiatric condition, available alternatives, and available safety information. These principles are consistent with the approach established in SRI’s current Expanded Access protocol. SRI-JMF-EAP01_Protocol_v1.0_29SEP2026.pdf
Individualized Eligibility and Safety Review. Approval is not automatic based upon diagnosis or severity of illness. Each request will undergo individualized medical and, when appropriate, psychiatric assessment. SRI/FTHF may decline or defer treatment when an unresolved medical, psychiatric, medication-related, substance-related, or other safety concern makes administration inappropriate. The Investigator retains authority to postpone or decline treatment whenever an unacceptable or unresolved safety concern exists. SRI-JMF-EAP01_Protocol_v1.0_29SEP2026.pdf
Regulatory and Ethical Requirements. Access will proceed only when all applicable FDA, IRB, controlled-substance, institutional, and other regulatory requirements have been satisfied and the investigational product can be lawfully supplied and administered. Expanded Access must not interfere with or compromise the ongoing clinical development of the investigational product.
The patient must be capable of providing informed consent or have an appropriately authorized representative where legally permissible. The consent process must clearly communicate the investigational nature of treatment, reasonably foreseeable risks, available alternatives, and the fact that clinical benefit cannot be guaranteed.
Treatment, Monitoring and Continuity of Care. Treatment may occur only at an appropriately qualified site with personnel, monitoring capabilities, emergency-response resources, and clinical oversight appropriate to the investigational product and individual patient’s risks. SRI/FTHF will require appropriate pre-treatment evaluation, safety monitoring, adverse-event reporting, post-treatment follow-up, and continuity-of-care planning. The current SRI protocol illustrates this approach through medical and psychiatric screening, medication review, clinically appropriate diagnostic testing, direct observation, emergency procedures, discharge assessment, and structured safety follow-up. SRI-JMF-EAP01_Protocol_v1.0_29SEP2026.pdf
Decision-Making and Equitable Access. All requests will be evaluated individually using medical need, available scientific and safety information, regulatory eligibility, operational feasibility, product availability, and the overall benefit-risk assessment. Decisions will not be based on a patient’s ability to generate publicity, donor status, personal relationships, or other considerations unrelated to legitimate clinical, ethical, regulatory, or operational factors. Approval of one patient’s request does not create an entitlement to treatment for that patient or others and does not obligate SRI/FTHF to approve subsequent requests.
SRI/FTHF reserves the right to approve, deny, defer, or discontinue Expanded Access when necessary to protect patient safety, comply with regulatory requirements, preserve investigational-product supply, or protect ongoing clinical development.