If FDA can change the primary endpoint of trial requirements mid-stream every bio-tech company has to be asking themselves if they want to fund costly trials in the first place. None of the other kidney cancer drugs were held to the same standards in their approval process. Glaxo Smith Kline's drug Votrient was run against placebo and won approval.
Aveo could and should have done a better job with their trial design to ensure against anomolies. But the result is that kidney cancer patients will be denied access to a drug that provides longer progression free survival than any other drug on the market and has fewer or less severe side effects than other drugs. FDA made its point, but kidney cancer patients are stuck with explosive diarrhea.
Corrected on : Corrected on 5/14/13: An earlier version of this post had an incorrect byline. It was written solely by Dena Battle.