At the AMLN expert user conference I had a long discussion with the FDA's statistician as he had made an obvious error in his evaluations. At the time I had just finished teaching advanced statistics and forecasting which included PhDs. (came to the conclusion that OLS is the BLUE)  He was not a PhD and he screwed up so maybe an exception to your comment, maybe not. I asked him why he had made such a basic mistake and he said the supervising MD had ordered him to do so. I won't get into the reasons why. Its not a cut and dry process that is dependent solely on the statisticians.

 

To rephrase, why can't the expert user group ask that combined with drug use be reviewed? After all they do have a vote.