Depends if the EU results will be similar to AUS, if so the CE submission will be for all respiratory diseases with 80-90% accuracy, i.e. similar to the TGA submission and given EU doctors tend to use "similar" adjudication process for respiratory diseases as us compared to the US, I suspect the results will have the same accuracy and it won't be the 60-80% seen in the US.
If you combine both TGA and CE regulatory markets it will be the size of the US but the China market will possibly be 2X the market of the US, pps of $1 is a MC of $700M for CE and TGA market for adult and children, I can see that in 1-1.5 years, but add FDA and CFDA, I see at least 3X the valuation so there is a lot of money to be made and not a few bucks if they get all these approvals.........that's the billion dollar MC question.
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