I believe when CE Mark approval arrives we will go into a trading halt and when the market opens the SP will be up about 50% (rough guess) on the pre-close price and then it will go a lot higher, I think taking this into account patience will be rewarded even if it arrives in Sep. 2020....but if you are not holding when the halt gets announced you will be extremely pissed off...
Ann: CE Mark Update, page-305
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