RE:RE:RE:Waiting...inthno,
As recall those days, Brad Thompson was both overconfident and constrained by lack of capital. He also felt their team could just figure out what to do and somehow do it. After they collected the data (I seem to remember some shapy aspects of that) the FDA insisted they segment the data into two groups. As a result they could not get statistical significance at .95 although it was very close.
An analysis at the end of the trial showed that were the data pooled they would have had marginally acceptable statistical significance. But probably no support from the FDA or a panel.
Here is one key point that is rather obscure. I recall they had planned to do what is called a Bayesian approach to the statistical tests. Years later I actually attended a conference and gave a talk in the big hall of the Silver springs campus of the FDA about communicating uncertain and risk management for pharmaceuticals. There I learned that although the FDA does accept Bayesian analysis for certain medical devices when the new device is a small refinement of an existing device, they had never accepted a Bayesian analysis for a new drug.
So in essence, ONCY was attempting to do something no one else had ever had accepted by the FDA, in hopes of reducing their sample size. That told me a lot about Brad Thompson. That and hiring his daughter (with virtually no experience) to be the head of strategic planning for ONCY showed real arrogance and lack of judgement. I was about to give up at that point, but then Matt took over. I called Matt and he talked to me at length about former problems in general terms, and my confidence that they may have a company that could do something with pela was restored.