Australian antiviral developer Island Pharmaceuticals (ASX: ILA) has provided an update on its ongoing engagement with the US Food and Drug Administration regarding the clinical development of Galidesivir.
In correspondence received on Jan 2, the FDA confirmed it is progressing its review of Island’s recent submission seeking clarifications on the drug’s development pathway under the Animal Rule.
This follows prior confirmation that Galidesivir is eligible for approval under the Animal Rule and for a priority review voucher.
Island noted that no adverse feedback or requests for additional data were received in the latest correspondence and that discussions with the FDA remain constructive.
Preparatory activities continue in parallel, including planning for non-human primate studies and engagement with US government stakeholders.
CEO Dr David Foster said the additional review time reflects the FDA's careful consideration of Galidesivir's next phase of development and affirmed the company's focus on advancing the program efficiently once guidance is received.