can’t recall. cT1 or PDFF. One of those used to

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can’t recall. cT1 or PDFF. One of those used to be measured by a biopsy and now by MRI. Either way, wouldn’t (or won’t rather) our P3 trial be expensive and take awhile? Especially if we do as you suggested in an earlier post, 1500 patients including 500 in placebo arm.

I guess what I’m wondering is what our p3 looks like really dialed in to things like haplotype, dose escalation, and how expensive and how long will it take. Too much for you to answer. A lot and too long, is sufficient.

What I’m really asking I guess is how will cD1 and PDFF levels be obtained?

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1500 patients would only be needed if the results were weak. Leronlimab doesn't have that problem. Even 500 would be cautious and give you a good confidence interval and fibrosis/PDFF statistical significance in either 350mg or 700mg. Three arms are not needed, you can either do dose escalation or simply go with 350mg.

For fibrosis testing patients would already have a biopsy showing NASH as an inclusion criteria. Most likely a cT1 test would be done at the beginning, at the midpoint for DSMB analysis and at the end. At the end a liver biopsy would also be done.

For PDFF a liver scan at the beginning, midpoint and end.