So if the FDA view the treatment of Vivagel BV drug application in the following light, then as long as SPL get a move on and submit some time soon, it could be approved mid year 2017.
"Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months." (FDA)
The FDA will determine its eligibility for Priority Review or SPL can request this status.
Otherwise a Standard Review will take 10 months + and we're looking at late 2017 or 2018.
Ann: Enrolment complete for Phase 3 VivaGel BV-R program-SPL.AX, page-22
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