FDA Is 100% Behind ACAD / FDA Says ACAD Has Enough Compelling Data. post.
obvious many on board are clueless, read this:
Wall Street Journal 4/11
How often does the FDA tell a drug developer to dispense with a requisite, second late-stage trial—and to proceed with filing a new drug application?
Acadia said the FDA agreed the company had enough compelling data for pimavanserin, its lead drug candidate proposed for treating for Parkinson’s disease psychosis.
The FDA usually requires at least two successful late-stage trials, but will accept a single trial under certain circumstances, such as a drug that satisfies an unmet medical need.