Overwhelming efficacy - the stats required, page-190

Since we're all waiting for the interim readout, i wanted to share a few links to give everyone an indication of what the possible outcomes are. Pluristem have an interim readout coming for their pivotal Phase III Critical Limb Ischemia (CLI) Study which reads:

https://www.sec.gov/Archives/edgar/data/1158780/000121390020018046/ea124396ex99-1_pluristem.htm

The interim process and possible outcomes:

An analysis of the interim data will have three possible outcomes: a) an earlier than planned end-of-study may be achieved if the top line interim data analysis achieves overwhelming efficacy (p ≤0.01), b) the study may be declared futile if there is no probability of successfully achieving the primary endpoint on the full data set after enrolling all patients, or c) the study is in line with the protocol assumptions and considered to be in a promising zone for success. If the third possible outcome results, Pluristem will continue to enroll patients, and will analyze the data again on the full data set.


And if we achieve overwhelming efficacy we can expect the following:

The DSMB recommended the study be stopped "due to overwhelming evidence of efficacy seen in the predefined interim analysis,"

The DSMB's conclusion is "[whatever DSMB's analysis uncovers]"

The interim analysis results will likely be sent to the FDA which may then consider fast-tracked submission for review and accelerated approval for the product in the U.S.

https://www.streetwisereports.com/article/2018/07/31/interim-readout-for-pharma-trial-delivers-home-run.html

So in short, I think we (and possibly also MSB) will not receive any statistics and will instead only hear whether the COVID ARDs clinical trial will 1) be stopped for futility, 2) stopped for overwhelming efficacy or 3) continue on as planned.

So what do people think about the chances of the trial being stopped for futility? Evidence-based opinions preferably.