I think you need to review your knowledge on CE mark and also Brexit along with understanding trial data and think about the now closed IMO "backdoor" access to UK market was achieved. That is the big picture.
I would start with the basics and look at why they had to do a postmarket trial to start with and the critical date where all grandfathering for Brexit ceases.
I would then think about if the UK will now accept Viraleze as a device without grandfathering.?
So I wonder when CM will tell us where they are up to with TGA since postmarket trial failed to meet endpoint and where communication is up to - Is TGA waiting on response from SPL or SPL awaiting one from TGA and the timeframe of each option?
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