This announcement is a very, very good sign for MSBThe criteria...

This announcement is a very, very good sign for MSB

The criteria set to achieve overwhelming efficacy was set very high, as indicated by SI, that if mortality was similar to that seen in the EAP/IND then we would get overwhelming efficacy at any one of the interim analysis. You have to also remember the p value required is usually very low (much less than 0.001) at the first interim analysis point to deride the false positive rate due to having multiple interim analysis points. Even if we received a mortality rate of 55% in the placebo group and 25% in the treatment group, this is still not enough to receive an early stoppage due to overwhelming efficacy at the first readout.

Contrary to what some people have suggested, this announcement indicates remestemcel-l for COVID-19 is actually working. This is because the trial is powered to allow for a conservative estimate of approximately 35% mortality rate in the placebo group and 20% in the treatment group. If the % mortality was any tighter than this at the first interim analysis (say 30% mortality in the placebo group and 20% in the treatment group), then the trial would have been terminated (or altered) since the trial is not powered to achieve anything worse than the 35% to 20% mortality split. So at a minimum I would say we are seeing a mortality rate of 35% in the control group and 20% in the treatment group, but as high as 60% in the control group.

SI has mentioned that we wouldn't even be in a position to supply the treatment until some time in 2021, so what's the rush folks? Expect us to reach overwhelming efficacy at the 60% readout!