Starpharma at stalemate with FDA on VivaGel

Australia’s Starpharma (ASX: SPL) has announced that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel BV (SPL7013/astodrimer sodium).

The FDA has maintained its position that the agency requires additional clinical efficacy data to be generated for the regulatory approval of VivaGel BV for bacterial vaginosis in the USA.

"This is not the outcome Starpharma was hoping for"Multiple submissions, meetings, detailed analyses, and the preparation of regulatory precedents relating to recent product approvals were part of the formal dispute resolution process.