FDA request more data for Starpharma’s infection gel approval

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.

Source link Finance News Australia

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