FDA decision on VIVAGEL Trail

Hello all,

I have created a new thread to solely discuss the FDA's requirement for confirmatory data. See below for a count on how many days it has been since this request and also a summary of the ASX announcement made by SPL at the time.

My questions are this:

1. What data has the FDA requested?
2. Why has the company not conducted another trail in the 603 days since this request was made? (This trail was quoted by SPL to only take ~4 months and cost ~$4 million)
3. How much money has SPL spent on the "FDA experts" they keep talking of that are supposed to sort this cluster f#ck out?