jad9000 - Please comment on the new FDA requirements
jad9000 • Aug 5, " I say they want an out and will allow a cursory "trial" to cover themselves and their bureaucratic nonsense. (approve)" jad9000 • Aug 5, 2014 3:17 PM You have no idea what the FDA wants.
terry_insm • Aug 5, 2014 "."By expanding the trial for the whole disease rather than a subgroup (refractory only), Arikayce would then be a treatment for a much larger patient population. Yes it will take a couple of years and yes it will cost a offering amount, but the FDA wants to approve a expensive drug for many in the disease group. "