I guess my glass is substantially more than half full if I'm the odd man out without anxieties about efficacy. After EINDs, CD10 results including reduced SAEs and lots of reading on cytokine storm and macrophage activation syndrome I have no doubts that Leronlimab works as advertised.
I just believe that covid causes endothelial injury with macrophage trafficking and activation. Coagulopathy, ARDS and death are the result. Stop the macrophage activation and win the big prize. Simple as a carnival game, just hard in practice. Give thanks for leronlimab.
Perhaps it is the case that reduction in mortality will no be as profound as I believe, but I have absolutely no doubt that it reduces mortality enough to matter clinically. Perhaps we will have to go to 390 patients, but failure due to lack of efficacy or adverse events is just not a concern I share.
The FDA, IMO, is opaque and capricious. Therein lie my concerns.
Let's hope after remdesivir and convalescent plasma that the FDA has pivoted back to science and evidence based medicine.