The FDA has acknowledged that with improvements to standard of care that 28 days is not sufficient to judge mortality benefit. The FDA is now recommending that trials follow patients for 60 days.

RLF-100’s trial just concluded a few weeks ago, just like Cytodyn. However, they were able to add the words “60 days” to their primary endpoint and are reviewing that data now. Why can’t Cytodyn do the same? Wouldn’t they be more likely to be statistically significant at 60 days? Wouldn’t that help with the other points as well? I’m just not understanding our approach.