But the non-medical professionals came to that conclusion in Hindsight.
When MSB started this trial there were almost no therapies, the older the people the higher the mortality , and ventilation was almost the only therapy to save people on the brink of death. They had no idea if the cells would work, who it would work for best for, when, how much to deliver - it was all estimated, and given out to a mixed bag of patients who didn't even receive remotely similar standards of care.
What does all this mean though? In the space of 12 months they have gathered an extraordinarily large amount of data that spans across a huge age range from fit and healthy people to people who had other medical issues already occurring. People that had been given the cells with minimal treatment or possibly no experimental treatment prior, to people who would have received multiple treatments prior. They have more proof of safety, the have logged the ventilation lengths, mapped the improvement in the ARDS condition with time along with key inflammatory markers that are utterly essential in justifying the business prospects and mechanism of action and the hypothesis of how the cells work. They are investigating the 6 month pulmonary systems for any long term signals including asthma, COPD, fibrosis and others.
The bottom line is in 60 days, the company has access to irrefutable evidence that will either demonstrate the link between Ryoncil, inflammation and fibrosis..... or demonstrate that it really is Disallowed, and while it may have worked in GvHD or the even the class 2 heart, they simply don't understand how or why and so any future indication expansion plans will be a pure shot in the dark.
I hope the refining of the patient target group is correct and I hope the data that is released supports exactly what the Prof is saying about excessive fibrosis being the key, which would then support the CHF results. I am also hopeful that this area is looked at for the Heart Failure results, and commented on before the COVID results are unblinded.
Right now, all we know is
They failed to reduce mortality by over 43%......after demonstrating some mortality benefit at the 30 and 45% marks.
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