That is a huge concern, the FDA establishing criteria that the FDA itself will actually adhere to, especially after seeing us record 84% improved survival rate after 2 weeks in a CD12 trial marred by DSMC/FDA misguidance bordering on possible sabotage and still no EUA. Even three weeks of negotiations and breaking down the stats in a fairer analysis with the FDA couldn't budge them off of their stubborn refusal to grant EUA.

That's my big concern with leronlimab - while the science, in both efficacy and safety, has been validated conclusively by trial and e-IND results, the FDA/BP-driven global resistance remains intact and will keep us out of the loop and allow people to suffer while the foot-dragging continues like some long-haulers obstruction disorder.

Like much of US gov't action/inaction these days, it's a crime in progress without a cop on the beat to stop it. If we see near-term approval it will likely come from someone with the guts to stand in defiance of the US hegemony. The Philippines, Hungary or Brazil seem like our best opportunities. Very happy to see us initiate trials in Brazil. It appears NP is looking beyond the US wall of defiance. Go get 'em Nader!