Cortinaboy you are absolutely spot on with your remarks and has...

Cortinaboy you are absolutely spot on with your remarks and has been my MAJOR concern with PXS mgmt. The whole fiasco with the FDA over 12 months ago(and the secondary test and why we went abck to $2) should have been seen well before it happened and now with the EMA. That is why companies employ specialist consultancies in the jurisdictions they are trying to do anything in let alone one of the hardest - a drug application!

Fortunately we do have good obvious clinical types at the helm for getting the drugs working for clearance, but my real concern is do we have the driven, capable and well experienced mgmt to move this company into a revenue producing beast! Based on both the FDA and EMA non understanding of the specific requirements in those jurisdications i am not so sure! Hopefully instos will force this one as they normally do on any board!

The one good thing is that the EMA like any EU institution that you will get the pleasure to work with is a bureacratic nightmare and they are more likely to judge the presentation on the suit and polished italian shoes that you wear than the contents of the presentation. I also forgot make sure you have a nice watch!! Being cheeky now but you must understand the class system in Europe and outside of the Brits, the euros are the most class conscious, status conscious people you will ever work with and i just hope the guys understand that! Again, why using an outside consultancy for these type of events!