The company has submitted its first national Clinical Trial Application (CTA) to the Food and Drug Administration (FDA) in the US for the start of their Xplore trial for Xlucane.
This application represents a significant milestone as the product enters the pivotal phase III trial that will support the Marketing Authorization Application, states the company in a press release.
“It is with great satisfaction we can announce that our first clinical trial application has been submitted to the first national regulatory authority. Submission of the applications in the remaining countries will be done over the course of the coming 1-2 months. The start of the trial is planned for March 2019 when we also expect to recruit our first patient. After having demonstrated high similarity in-vitro and in-vivo to the originator, it is with great excitement and confidence that we enter into this pivotal phase III trial with Xlucane,” says Martin Åmark, CEO of Xbrane Biopharma.