Biotech Values

[Deadb440]

So, the FDA is working to help companies get their drugs approved? Clearly not. Their goal is to ensure the endpoint is clinically meaningful, which may or may not maximize the chance of a successful trial.

"Their goal is to ensure the endpoint is clinically meaningful"

My point exactly - Not meant to undermine the rigidity of the tests by making an outcome easier to achieve but establishing clearly at what point there could be statistical significance achieved, and at what dose level, based on the Ph2 trial data....