new money, page-46

Utterly agree Goldie - what on earth made them think they could get FDA approval for all patients when Europe only gave them 16+? The FDA arent going to look beyond your request and suggest/award you a subset of your initial request - its all or nothing - Mar 18 will be a total rejection - the question then is how long until PXS can get in front of them with an appeal/request on a subset of the initial patient population. Given the FDA seems to have been far more aggressive than the EU on the statistical flaws of the trials my money thinks we will need another trial - so 3 years before approaching the FDA again!

This approval strategy has me scratching my head as to the competence of management more than anything else.