OncoSil Medical (ASX:OSL) has announced that the US Food and Drug Administration has confirmed that all outstanding questions regarding the company's Humanitarian Device Exemption application (HDE) for its device used to treat distal cholangiocarcinoma have been satisfactorily addressed, and that the application has advanced to the final stage of review.
The FDA asked OncoSil to submit final device labelling and any updates to its proposed post-market study within 30 days and indicated it intends to complete its review within 45 days of that submission with a view to granting the HDE.
The company said the FDA correspondence represents a significant regulatory milestone because it completes the substantive review and moves the filing to the last administrative step before a decision.
The HDE pathway applies to devices for rare conditions affecting fewer than 8,000 people per year in the United States and, if granted, would authorise the OncoSil device to be marketed for this indication under the standard oversight conditions of the HDE framework.
Distal cholangiocarcinoma is associated with poor clinical outcomes and limited treatment options, with an average life expectancy of six months for patients who do not receive treatment.
Nigel Lange, CEO and Managing Director of OncoSil Medical, said, “The FDA's confirmation that all outstanding questions have been resolved is a major achievement for the Company and an important validation of the extensive work undertaken throughout the HDE review process. Importantly, the FDA has now moved the application to the final stage before potential approval and has requested only the submission of final labelling and any updates to our proposed post-market study. We look forward to completing these final requirements and working with the FDA towards HDE approval.”