Markus, your statement about clinical trials is not correct. It has to show that it is at least as good as the existing standard of care treatment, not better than nothing. Phase three clinical trials (which may be the last step for some drugs even through there are stage 4 trials) indicate how the new drug works in comparison to the existing standard of care drug. Some patients get the standard of care drug, some get the trial drug. If a new trial drug cannot demonstrate that it is at least as good as the standard of care drug, it is dead in the water and will not make it to market. Many times it is dead even if it works no better or worse, but the same as, because long term side effects are unknown. http://www.oralcancerfoundation.org/facts/clinical_trials.htm