MSB Trading - 2020, page-18616

If that was the case then you could expect Mesoblat to receive approval for their remarkable phase II CHF clinical trial results. Unfortunately that is not the case since there's a key indicator called statistical power, which can only be achieved with a larger cohort size. For the 12-patient study, they also lacked a control group and it was open-label.

All too often these phase II studies do not materialize when you make studies double-blind (to remove bias) and include a larger cohort (for statistical power) and a control group (as a reference point). At the moment these MSC's are not considered to be a treatment for COVID-induced ARDS.

Imagine if you were on a ventilator and survived after receiving an experimental treatment, only to find that the treatment in fact did not work and yet it damaged your liver, heart or worse left you with cancerous polyps or teratomers, and in hindsight you would've survived perfectly without it.

The same argument can be made for hydroxychloroquine. Should you give it or not. Some research says if you give it you end up killing more people than you save. Should you continue? Probably not. An EAP would not have identified that the treatment may potentially be deadly, only a clinical trial can.