This is good news. It also makes sense to develop

This is good news. It also makes sense to develop the regulatory production in Europe. Earlier this year the FDA issued a document (I posted a month ago or so) that they would accept other manufacturing, validation, and quality measures where they those measures were as stringent or greater than what the FDA requires. This is a HUGE door for the right company to be able to develop protocols to meet EU and FDA requirements and once approved it won't take a year to ramp production in the US. (even once through clinical trials it has to go through manufacturing approval) I know this is possible to do because one of the last barriers with FDA manufacturing was this. About 10 years ago I worked as a compliance/regulatory officer for a major international pharma company and we were audited by over 16 international agencies. They just need to be smart with who they select to manufacture the product. Once protocols are established then they can easily transfer manufacturing to the US to cut down on taxes. It would only take about 3 months to get approval for manufacturing to do this and they could still be manufacturing and supplying EU and the US during this time.