When I first saw the inclusion of patients that entered Ordinal Sale 7 near the time of randomization, I also worried about the effect this group could have on the trial.
""Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO)." We did not do that in our internal trial. Our Hazard Ratio for mortality could be negatively impacted by this inclusion."
I don't trust either the FDA or the NIH, and I seriously would like to see the HHS Inspector General get involved overseeing a retrospective analysis of the available NIH trial date, as our as the one we did on our internal trial. We have got to remove any questions of trial data integrity, and determine why the FDA came to their decision to decline our EUA.