The EU is not necessarily implicitly conceding that the US FDA is its equal in terms of well-staffed, quality reviews. For example, all medical devices made in the US now have to receive a new 510-type review in the EU. Just saying, working with them may be a requirement, not a cost saving thing. We'll see. but decades of naysayers about US bureaucrats, and foolish austerity measures have had their toll, and guess what FDA is. Same with the shrunken, weak SEC. Only to be feared by some small companies and easy targets. Do I sound bitter, yes, I am.