Ann: Regulatory progress for VivaGel BV in the US, page-51

If the FDA want another trial to generate confirmatory data and they are indicating that this will suffice, provided the data is acceptable, then go ahead with the trial. $4m and four months? So what!
If the consensus is that the FDA are holding a carrot in front of SPL, and SPL are 100% happy with their initial trial results, then take them to court.
If it looks like the FDA will not approve Vivagel at all, then just drop it.

But whatever is done, do NOT let this interfere with or slow down ANY other ongoing work such as Vivagel EU launch, better marketing of Fleurstat, ph 1 irinotecan, Dep Doc, Japan condoms, etc etc. Sooner or later the USA will join the party, provided Vivagel is proving to be highly effective throughout the rest of the world.

Joohnno, still no response from the person you sent some Fleurstat to?