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:
- What data has the FDA requested?
- 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)
- How much money has SPL spent on the "FDA experts" they keep talking of that are supposed to sort this cluster f#ck out?
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- FDA decision on VIVAGEL Trail
FDA decision on VIVAGEL Trail
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