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Question and answers
Q: How does the light and FG001 work technically?
A: FG001 contains a molecule with fluorescent properties (a fluorophore). Fluorophores absorb light of a specific wavelength and re-emit light of a longer wavelength. Typically, a laser will create the light and a camera will detect the re-emitted light. Lasers and camera are built into microscope, robotic surgery equipment and endoscopes, and available today at the surgery rooms with the specifications needed for FG001.
Q: What is the expected sales price to hospitals for FG001?
A: A price only reflecting the hospital savings on re-operations and other increased costs of care, could be in the range of e.g., approx. EUR 40 000 in patients with glioblastoma and approx. EUR 4 000 per use in patients with breast cancer. This does not include potentially improved survival rate or improved quality of life for the patients. The price will be determined when the result of clinical trials is known and the magnitude of benefit from FG001 demonstrated.
Q: Does the FDA have clear guidelines or endpoints regarding the FG001?
A: Yes. FG001 is a medical product (drug) per definition and there are clear guidelines for medical products. Interactions with the regulatory agencies, such as FDA and EMA, are nevertheless important during the development. This shall secure that the specific issues related to FG001 and guiding of cancer surgery are discussed with the regulatory agencies during the development of FG001. The overall aim is to secure that new important products are brought to patients safely and quickly.
Q: What is a good way of measuring the surgical success of the FG001?
A: Post-surgery pathohistological examination is the golden standard and is a good measure for the surgical success. The pathologist investigates if the margins of the removed tissue contain cancer (termed ‘positive margins’) or the margins are clear of cancer (‘negative margins’). A surgical success is removal of all local cancer plus minimally normal tissue with a cancer free (‘negative’) margin. For glioblastoma specifically is post-surgery MRI the golden standard.
Q: What is the background of the two avenues to demonstrate safety of FG001?
A: uPAR differs between animal species. FG001 binds to human uPAR why we test its effectiveness in human cancer implanted in mouse. We also know that part of the molecule in FG001 responsible for the uPAR binding does not bind to mouse uPAR. We need to demonstrate FG001 uPAR binding for all the classic toxicity species before we conduct the study to avoid that we are asked to repeat the study before starting the clinical study.