RE: FDA-Study Latest4 Jan 2019 10:01
good afternoon Bignose.I couldnt agree more.i assume that the EMA is one of the most demanding authorities in the world (indeed based of recent UK political experiences its probably the most difficult and pernickety in the whole world!).the main point i wanted to make quite forcibly was really that whatever their shortcomings over matters in the past i would find it incredible that having got to where they are in europe china et al regent would not be treating the FDA application as of the utmost importance and doing all they can to ensure its success and i am sure they will not be treating the application in a cavalier or lighthearted way.also i don't believe that whatever the strict criteria of the FDA they will look at it completely in isolation from what is happening in the rest of the world and its experiences there .it must have some influence even if only subconsciously.trouble is we are going to have to be patient re USA and hope for positive sales news etc and perhaps ROW developments in the meantime.i hope the expected publicity campaign will bring some s/p improvement also .