The FDA guidance on meta analysis identifies a number of issues with Cytodyn’s situation, a few are: One is that the compassionate use and EIND data aren’t randomized trials. Second, they want the statistical method to include analysis that is difficult (maybe impossible) with such small sample sizes (ie sub group bias analysis and comparison). Finally, this analysis is being done post-hoc (which puts the analysis in tier three, the lowest acceptable) - if Cytodyn had planned a met analysis (and designed all trials, data collection, analysis plan) ahead of time it would be more acceptable.