Why IMU is a multi multi bagger, page-214

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if the number of patients is statistically significant , and the improvement over the SOC is clinically meaningful that is too good to ignore, such as PFS being significantly longer, 12 months vs 3 months for example, then the FDA can approve an accelerated approval or a fast track designation to go directly into PH 3. Or directly into an approved drug for sale . Data will continue to be gathered for further results but the new drug is made available to the people who will benefit most.

This is exactly what happened with Trodelvy and Enhertu, before Ph2 was completed , which then resulted both being bought out early (by Gilead and AstraZeneca)

Many statistics websites will tell you for a clinical trial the magic number of patients to be considered “statistically significant” is between 20-30 , and the p value should be less than 0.05, ( probability that the result was just good luck and not due to the drug) and a confidence interval for the results greater than 95%