Not sure what the big mystery is with your questions about Europe, its been a known fact for the last several years that the leadership of this company sees the best route for shareholders as an acquisition, JV or some type of partnership. All efforts have been geared in that direction.
Could they have already been setting up a bigger manufacturing site to serve Europe while gaining FDA approval? I suppose so, but that has not been the strategy. With the recent announcement of moving the smaller pilot site from China to Baltimore and starting the process to ready a facility for high volume production tells me that a partner or acquiring company outside of the gauze industry is influencing their strategy and wants at least to have the first phase of manufacturing start up in motion.
The reality is that only a few people really know all the inside information and how things are playing out.....what most longs now know is that the company is going to have a very, very big asset in their pocket upon official approval....its debated every day how much that is worth, but I am confident in saying that its ALOT more than the current PPS