Every Tom, Dick and Harry is touting their products as possible treatments to covid ards.
From steroid creams, to Vitamin C tablets, to the variety of "drugs" shown to have anti-cytokine benefits (msb fits in this category) all of which everyone is on some sort of trial. There are hundreds of drugs/treatments that are being touted.
For me, I think our biggest hurdle will be showing efficacy on mortality rates. With our earlier 12 patient trial, I believe the mortality rate being touted at the time (83%) was inflated for those serious patients. That just seemed way too high, and even if it was back then with the improvements to standard of care today, I believe we would have a survival rate of 70% for those serious cases (excluding elderly and those with pre-existing conditions as per our trial). Of course this is just my opinion as the survival rate of those on ventilators is very murky at best.
And so, for us and to get FDA approval we need to show that those 150 patients given our cells have a much higher survival rate than the placebo cohort. And yes, this is the only thing that matters as mortality is the primary endpoint for this trial. I just don't believe we are going to see that much of a difference is my opinion only.
Happy to be wrong.
Best case scenario for us is there is some efficacy and we are asked to do another trial with a larger group.
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