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Posted On: 03/31/2024 3:41:43 PM
Post# of 154737
From Ohm20's post 141608:
Quote:
Do you like the primary endpoints that we've chosen?
CRP and the newer EN-RAGE are standards for inflammation and we should do well on both. What I'd like to know is how many secondary biomarkers they're going to do immunoassays on. The broader that is the better.
Quote:
Will 90 patients split into 3 groups (350, 700, and Placebo) be powered enough to show significance? I guess this trial isn't to get us approval so it may not be all that important here.
There's sure to be a pooled analysis and a breakdown of both subgroups. The higher the base inflammation level is in the inclusion criteria the greater chance of showing statistical significance. I'm sure Dr. Lalezari has factored that in and has a suitable level. We did well in the NASH trial with 30 on drug and 30 on placebo so I would expect the same good results. A phase 2 trial needs to show promise of efficacy but not necessarily statistical significance to go on to a phase 3 trial.
Investors Hangout: https://investorshangout.com/post/view?id=667...z8W5Ex5mQ9
Quote:
Do you like the primary endpoints that we've chosen?
CRP and the newer EN-RAGE are standards for inflammation and we should do well on both. What I'd like to know is how many secondary biomarkers they're going to do immunoassays on. The broader that is the better.
Quote:
Will 90 patients split into 3 groups (350, 700, and Placebo) be powered enough to show significance? I guess this trial isn't to get us approval so it may not be all that important here.
There's sure to be a pooled analysis and a breakdown of both subgroups. The higher the base inflammation level is in the inclusion criteria the greater chance of showing statistical significance. I'm sure Dr. Lalezari has factored that in and has a suitable level. We did well in the NASH trial with 30 on drug and 30 on placebo so I would expect the same good results. A phase 2 trial needs to show promise of efficacy but not necessarily statistical significance to go on to a phase 3 trial.
Investors Hangout: https://investorshangout.com/post/view?id=667...z8W5Ex5mQ9
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