I may be wrong, but I believe investors, who may have had knowledge of what was happening at certain sites, reported inspections, I don't remember the company actually reporting it, though perhaps DI let something slip, that's really not official.
If you look at the official Europeant timeline, they have two RFI periods built in with up to 3 months in each. I believe that the UK operates that way, even if it's not documented that way. If you look at that, we're really not that far out of the time that's anticipated. Clearly the British have been slowed by Covid, other approvals have been coming that began at about the same time we filed. I certainly wasn't expecting it to take so long, I've gained a respect for the FDA and their PDUFA dates, but it seems that the UK and Europe are all taking this kind of time on many of their approvals. I still strongly believe that no answers come much faster, and the sponsors are told what actions are needed to gain approval the next time, if they meet requirements. A confirmational trial may be required, but I think our odds of approval are 99+%.
Gary
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