>>…this is prudent delay to wait for European approval, tradeoff is slower sales ramp up<<
I don’t think this will slow down sales at all. If the EMEA gives a positive opinion, the company can start the manufacturing scale-up while the MAA is awaiting rubber-stamping by the EU Commission, a 2-3 month process.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”