Starpharma Holding ’s announcement that the US Food and Drug Administration had granted an agreement regarding the design and planned analyses of Phase 3 clinical studies of its VivaGel bacterial vaginosis product appeared to go unnoticed by the broader market.

However, the granting of a Special Protocol Assessment is highly significant given it provides a binding agreement from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product.