Quote:There is one obvious bio-marker, or end point if you will, that I came up with... And that would be--drum roll, please--all-cause mortality! If significantly fewer of those HIV patients on leronlimab died of cancer or atherosclerosis... well, that would be quite a signal.
(I hate to say this, but I can imagine the crew at the FDA, when they see this, just scratching their heads and going--"Jeeze... Really? What do we do with this now?"
For long term use in HIV the only data we may have outside of the trial period is death unrelated to leronlimab usage with no specific cause of death. This would be a small set of patients. Outside of HIV we would only have data for the follow up period of the trial. Comparison data from mortality with other HIV drug use is probably available from meta-analysis. Only our long term data would be of any use because death by other causes takes a long time. But the sample size would be so small that it wouldn't be positive proof. Widespread use of leronlimab can give us the data.
We have a good idea of what leronlimab can do and personally I think that it would be of benefit for many as people age. In aging there's enhanced gene damage and misrepair, lack of clearance of senescent cells, mitochondrial dysfunction, immune dysfunction and inflammation which can lead to disease states. All of which leronlimab can help.
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