Starpharma Holdings Limited (ASX:SPL) has scored a win for its phase 3 clinical studies of the VivaGel bacterial vaginosis product for the prevention of recurrent bacterial vaginosis.
The pharmaceutical company says the US Food and Drug Administration (FDA) has now granted Special Protocol Assessment agreement on the design and planned analyses of the studies.
CEO Jackie Fairley says the announcement effectively eliminates the US regulatory risk associated with clinical development by specifying upfront the FDA’s agreed trial design.
Dr Fairley advises the agreement is protected by US law and gives Starpharma certainty and confidence its studies will support a regulatory submission for the approval of VivaGel.
Starpharma Holdings booked a net loss of $5.6 million in the first half of the 2014 financial year.
