Starpharma (ASX: SPL, OTCQX: SPHRY) today releases its Interim Report and Half-Year Financial Results for the period ended 31 December 2023 (H1 FY24).

Starpharma (ASX: SPL, OTCQX: SPHRY) today announces that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel^® BV. The FDA has maintained its position that they require additional clinical efficacy data to be generated for the regulatory approval of VivaGel^® BV for bacterial vaginosis (BV) in the US. The formal dispute resolution process involved multiple submissions, meetings, detailed analyses, and the preparation of regulatory precedents relating to recent product approvals. Starpharma was supported through this process by highly experienced regulatory advisers, key opinion leaders, and biostatistical and legal advisers, including several who were ex-FDA.