RARP with ePLND
Intuitive Fluorescence Imaging, LLC will consider expanded access requests on a case-by-case basis when ALL of the following criteria are met:
Patient-Specific Criteria
Serious or Life-Threatening Condition
The patient has a disease or condition that is immediately life-threatening (reasonable likelihood of death within months), OR
The patient has a serious disease with substantial impact on day-to-day functioning.
No Satisfactory Alternatives
All approved therapies appropriate for the patient’s condition have been exhausted, are unsuitable, or are not available.
The patient is ineligible for enrollment in any ongoing clinical trials,
OR
No clinical trials are available for the patient’s condition or geographic location.
Potential Benefit Justifies Risk
The potential clinical benefit to the patient justifies the potential risks of treatment.
The patient and treating physician understand and accept these risks.
Product Development Criteria
Adequate Safety and Efficacy Data Available
Generally, adequate data is available after completion of Phase 2 clinical trials or upon receipt of FDA Fast Track or Breakthrough Therapy designation.
An established recommended dose has been identified.
Preliminary evidence suggests potential benefit for the patient’s condition.
Active Clinical Development
Intuitive Fluorescence Imaging, LLC is actively pursuing marketing approval for the investigational medicine.
Clinical trials supporting potential approval are ongoing or planned.
No Interference with Clinical Development
Providing expanded access will not compromise the enrollment or conduct of ongoing clinical trials.
Adequate drug supply exists to support both clinical trials and expanded access without creating shortages for enrolled trial participants.
Regulatory and Logistical Criteria
Regulatory Compliance Possible
The request can be fulfilled in compliance with applicable U.S. and local laws and regulations.
A regulatory mechanism exists to support expanded access in the patient’s country or region.
Institutional Review Board (IRB) or Ethics Committee approval can be obtained.
Licensed Physician Oversight
A qualified, licensed physician agrees to:
Oversee the patient's treatment
Obtain informed consent
Submit required documentation to the FDA and IRB/Ethics Committee
Monitor the patient and report outcomes to Intuitive Fluorescence Imaging, LLC and regulatory authorities
Serve as the IND sponsor (if applicable)