Ann: Ethics Approval to Treat COVID-19 Patients in Australia, page-104

The 'overwhelming efficacy' will speak for itself and needs to be considered in context. We're talking about a virus which has no approved treatment for ventilator dependent patients.

Any statistically significant difference between the treated and non-treated cohort will be overwhelming effective compared to anything else available - which is currently nothing.

What chance is the FDA of declining to approve a treatment, even if it was only fifteen or twenty percent more effective than the SOC, in the face of 160,000 deaths already and an increasing infection rate. Ten percent of 160,000 people is a lot of people.

What justification (if safety is proven) would there be for not approving?

I think a lot of people (me included) consider that any result less than the compassionate trial result (75-83%) would not be considered overwhelming effective - I think we are very wrong in assuming that. My suspicion is that even a much smaller number than that will lead to early approval.

Is it safe?
Does it work?
Is there any other treatment available?

In my opinion if the answer to the questions is Yes, Yes and No - it'll get approved - they're not going to quibble about definitions and statistics if people are dying - especially if this treatment will clearly help some.

I also see the Australian arm of this trial as a political de-risking of the process. TGA and FDA approving at the same time will make it look less like there has been any political interference. It also looks like a joint fight against a common viral enemy. It provides the optic that the solution is shared between long time allies and friends and doesn't belong to any one political player. This will assist MSB - and hopefully not get it dragged into a political dog-fight at this stage of the US election cycle.