the FDA have just come out and moved the goal posts for TREATMENT of BV.
NOT for the prevention of recurrence (which is what the current phase 3s are)
This has obviously happened recently, hence why we are hearing about it now.
IF the FDA had the this benchmark for treatment of BV back in 2012 THEN SPL would have met the primary endpoints trial BACK IN 2012.
BUT NOW, spl can go to the FDA with the data generate from the 2012 trials and apply for the TREATMENT of BV indication.
Apologise if I sound condescending but cmon thrasher, seriously?
Ann: Enrolment complete for Phase 3 VivaGel BV-R program-SPL.AX, page-12
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