Powering the study to answer the question clinical

Powering the study to answer the question clinically is typically determined by a statistician who looks at study details (how many study arms etc) with the principal investigator and provides guidance. Dr Jay has deep research experience and would be well aware of all this and guaranteed won’t fall into the trap of doing an under-powered study. Power in turn is driven to some extent by clinical inclusion/exclusion criteria which informs clinical outcome probabilities. As a result any guess on my part or anyone here is just that, a guess based on a true lack of needed detail.

Throwing big numbers at a trial like Gilead did with Remdesivir makes it easier to hit the coveted p-value even if clinical impact is marginal. Dr Jay I believe is holding his trial chips for higher value carve outs where there is unmet need and huge clinical impact, bringing the number needed to treat down. MSS CRC is a great example of that. A re-evaluation of TNBC data is another. Getting that study of Leronlimab safety data published might be a key component going forward. If the ladies with multi-year survival were functionally cured from TNBC, and an argument can be made based on published data that Leronlimab has a stellar safety profile such that there is little to no downside to use, that is a picture of breakthrough therapy BP and the FDA could not ignore. The results scheduled to come out in conjunction with the Munich conference could be quite interesting and I love the approach of mining existing data which obviated setting up a new trial and without the scarce resources of time and money in short supply. If the results are on the level of making even a dog drop it’s bone, it will act as a magnet for money from a partner in which case properly powering the study would be a foregone conclusion.