A couple of quick comments: 1) A study properly c
Post# of 154593
(Total Views: 440)
Posted On: 03/06/2024 10:26:40 AM
Re: HouseofCards #141579
A couple of quick comments:
1) A study properly conceived always brings a statistician in so that it can be determined the N to power the study sufficiently to answer the question. JL has deep clinical trial experience, and understands that need. Moreover the FDA is also looking over their shoulder and may have commented on that.
2) This study isn’t a pivotal approval trial, it is designed to show clearly that there is impact on inflammatory processes. The equivalent of “yup, thar’s gold in them hills.” The land rush and mining operations come later.
3) This is not the most expensive study to do, we are talking a patient population inflamed out of the gate with inclusion criteria of elevated CRP. We know in advance per the phase 2 NASH trial that Leronlimab brings down CRP and EN-RAGE. Let’s illustrate lab impact, and dose-response with two different doses and a placebo group left in the dust. This is not a zero cost study but we are talking patient screening for inclusion while collecting info on pertinent comorbidities, drug profile etc with a handful of labs over a limited time, weeks, not years.
4) I like the primary endpoints…we have a drug already proven to move the needle for both. Keep it simple but collect additional markers for secondary evaluation which may also be used to show the jury and paint a logical picture and mechanism of action.
Remind yourself, we are just trying to point out that there is a Klondike grade gold strike here…the BP C suite will lose the tie at that point and show up at the Chilkoot pass, count on it…clear teaser data obtained at modest cost is what we really need at this point.
1) A study properly conceived always brings a statistician in so that it can be determined the N to power the study sufficiently to answer the question. JL has deep clinical trial experience, and understands that need. Moreover the FDA is also looking over their shoulder and may have commented on that.
2) This study isn’t a pivotal approval trial, it is designed to show clearly that there is impact on inflammatory processes. The equivalent of “yup, thar’s gold in them hills.” The land rush and mining operations come later.
3) This is not the most expensive study to do, we are talking a patient population inflamed out of the gate with inclusion criteria of elevated CRP. We know in advance per the phase 2 NASH trial that Leronlimab brings down CRP and EN-RAGE. Let’s illustrate lab impact, and dose-response with two different doses and a placebo group left in the dust. This is not a zero cost study but we are talking patient screening for inclusion while collecting info on pertinent comorbidities, drug profile etc with a handful of labs over a limited time, weeks, not years.
4) I like the primary endpoints…we have a drug already proven to move the needle for both. Keep it simple but collect additional markers for secondary evaluation which may also be used to show the jury and paint a logical picture and mechanism of action.
Remind yourself, we are just trying to point out that there is a Klondike grade gold strike here…the BP C suite will lose the tie at that point and show up at the Chilkoot pass, count on it…clear teaser data obtained at modest cost is what we really need at this point.
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