Thank you! I mentioned this several times the last month or two. 165 is small and no increase in trial size is a huge sign.
“Relief expects them in January. Zilian notes that the target number of patients has been increased from 144 to 165. This rather indicates a hedge against a weak data trend. The analyst sees this as an opportunity to achieve statistical significance later on with a trend that was initially not very pronounced. By increasing the number of participants, the statistical significance is increased. According to Selvaraju, the increase in the number of participants was suggested by the U.S. Food and Drug Administration (FDA) even before the first interim analysis. The Data Monitoring Board did not recommend any further increase. He sees the fact that Relief does not need to recruit thousands of patients, as is the case for some studies for the approved remdesivir, as an encouraging sign. The study objective - to demonstrate the reduction in mortality of Covid-19 patients, with acceptable side effects - was most likely not achieved prematurely. If the data had already been statistically significant, the monitoring committee would probably have recommended discontinuation on Thursday. However, it has requested the continuation of the study, expressing that after analyzing the data from two-thirds of the targeted number of participants, it considers the achievement of the study goal to be realistic”