jimmy667 Friday, 03/01/19 10:00:30 PM Re: nidan7500 post# 183453 Post # of 243613 Could this phenomena or problem of using untoward resources of the FDA on large Amyloid Trials be a consequence of the very User Fee Act that to a large part funds the FDA? Does not the ones who pay the Piper (FDA) get to call the tune? In other words is the dominance of the FDA by BP facilitated by the User Fee Act (PDUFA) since that is what funds the FDA that BP can chase the resources of the FDA down rabbit holes so they do not have the time and resources to divote to promising or even paradigm shifting new drugs of smaller innovative Biopharm Companies and therefore retain their dominant positions in the Drug Industry? How would Dr Peter Singe analysis the PDUFA dilemma? Does not in fact the PDUFA by Act of Congress cede effective command and control of the FDA to the deep pockets of the BPs? It seems all baby Bios can do is clinically try Orphan Drugs where PDUFA fees are waived or discounted. What the heck is Bill Gates doing? We need real philanthropists like Andrew Carnegie of a prior era that actually use their wealth to make a difference. (System of public libraries which was a huge benefit to the people of the USA) Down with the Pharmaceutical Drug User Fee Act. It needs to be abolished as it grants a strangle hold on the FDA by BP. He who pays the Piper calls the tune. Those same Pigs are always at the Tits of Government as long as the money is Green. As in overcharging Fed programs like Medicaid for the drugs. Long AVXL. Let her torches burn bright so she can show the way to other innovative Biotechs navigating the mine fields sown by BPs and their lap dog the FDA.