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Ohm, I would love to hear your thoughts on this new trial we're hoping to run. Should we expect to "move the needle" as he said?

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The initial trial is almost certainly a phase 2 trial using reduction in inflammatory markers as the primary endpoint. The best look at what leronlimab does with inflammatory cytokines is from the NASH trial and "he who shall not be named's" Covid study. Leronlimab certainly did it's job in both. They should be looking at levels of immune boosting and regulatory cells also.

A phase 3 trial will be a real doozy, the FDA will be looking for clinical benefit so the protocol will undoubtedly look at most areas that are affected, potentially brain fog, heart problems, liver damage, kidney damage. A hell of a lot to look at but positive results should set the FDA back on it's heels and make them aware that leronlimab is not just an HIV drug.

Of note, I thought there was something screwy with the NASH 750mg results. I thought either there was a screw-up in the trial itself or blind chance because of the trial size. Dr. Lalezari has figured that out.

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When I first thought about the study, I was put off by the fact that 350 was significant, but 700 wasn't. Having reviewed the top-line summary now, I understand that the changes in markers were in the same direction with 350 and 700. It's not like 350 worked and 700 didn't work. They were both moving the markers in the same direction, and I think it's a small study. And in fact, what I take away from it is that it's amazing that anything moved at all after 12 weeks of treatment. We do six or seven NASH studies treating patients for a year, and more often than not, we see nothing happening.

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