Biotech company Starpharma (ASX:SPL) has received advice from the US Food and Drug Administration that it will require more clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis.
Starpharma anticipates being able to address the issues raised.
The company is requesting a meeting with the FDA as soon as possible.
Starpharma will also be discussing next steps with its US partner, ITF Pharma, and any potential impact on its US licence.
VivaGel® BV is already approved in the EU and Australia, and regulatory processes currently underway continue in other markets and are completely independent of FDA approval.
Shares in Starpharma (ASX:SPL) closed 29.64 per cent lower at $0.98 yesterday.