Anavex Life Sciences Corp (AVXL)

[Steady_T]

All P3 trials are a big risk. The larger the trial the more sensitive the trial is to statistically valid effects. In a very large trial the effect can be quite small and still be statistically significant.

Because an effect is statistically significant does not mean that the effect is clinically significant.

Many drugs have an effect on 30 to 50% of the population. That drags down the effect size in the stat analysis because of the people that the drug does not affect are lumped into the analysis. One of the advantages of precision medicine is that it identifies the sub population of the general population that the a drug will affect. That allows the statistical analysis to be done on just that population without the dilutive effects of the non affected population.

P3 trials do have an element of safety trail involved. The numbers in P3 trials are larger and are more likely to discover low frequency significant adverse events that a smaller n trial might not see.