Island Pharmaceuticals (ASX:ILA) has completed submission of all briefing documents to the US Food and Drug Administration (FDA) ahead of its Type C meeting, aiming to advance the approval pathway for its antiviral drug, Galidesivir, according to a Monday filing with the Australian bourse.
The meeting will center on securing FDA alignment for using the animal rule in Galidesivir's clinical development and approval, with the agency expected to provide written feedback by Nov. 12, the filing said.
The submitted documents include Galidesivir's clinical history, pharmacokinetics, safety data, non-human primate study results, and rationale for the animal rule, per the filing.
The company plans to finalize a strategic partnership ahead of the FDA's response to advance its Marburg animal study, targeting completion in the fourth quarter of the year, the filing added.