On ABT’s CC yesterday, the company was asked (again) why the FDA would consider approving this NDA. The non-answer answer: the Agency accepted the application for filing.
Perhaps I should construct an iHub survey to ask which drug with a shaky data package has a better chance of approval: Xinlay or Retaane. I could even add Erbitux in H&N cancer to the mix.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”