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Saying it's not unmet need ?

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Leronlimab would meet the requirement for unmet need if it blew away TAS-102 and bevacizumab results. Rather hard to do in a phase 2 sized trial that has 30 patients in the leronlimab, TAS-102, bevacizumab arm. Even in that small of a trial we should see statistical significance. But there's certainly not enough patients to have a very large p value coupled with a high confidence interval. With a small trial the FDA would want to see at least 4 digits in the p value and a confidence interval of 95%. Give it some time and we'll see who is right.