Nope. Despite what people might tell themselves, the odds are heavily stacked against ZGNX. It is extremely rare for the FDA to ignore an AdCom's recommendation. I won't be holding through the decision.
How Often Does The FDA Agree With Its Panels?
By Ed Silverman
After most FDA advisory committee meetings, the standard reaction to any vote is the FDA does not have to follow the advice of its panels, but often does. But is that really true? Well, it turns out the agency does follow recommendations from its advisory committees most of the time – 74 percent, to be exact, according to Prevision Policy.
Another issue closely tracked is whether the agency makes its decisions on time. And the answer is…60 percent are, indeed, delivered on time. Of course, this means 40 percent are not. On time, by the way, was defined as making a decision by the user fee deadline, while a delayed decision meant the agency missed or took action that allowed a formal extension.
To reach this conclusion, Prevision Policy analyzed Center for Drug Evaluation & Research advisory committee decision from 2007 through 2010. All new molecular entities and new indications for existing marketed drugs were reviewed, which amounted to more than 120 cases in the last four years, the firm indicates.