Lenzilumab needed to change 3 times primary endpoint during this study......
First they removed mortality , and use length of hospitalization.
At this time for Lenzilumab was about 6 days and otherwise 9,
but as SOC improved , length of hospitalization went down to 7 days , so company needed to change again , since they will not meet the endpoint ..
And of course during interim DSMC advise to add patients if any hope to accomplish positive results ..
Yes I am worry how this study will end up.
Leronlimab , stood with mortality as a primary endpoints , I bilieve the only company finishing study with mortality as a primary endpoint.
during interim , no changes were advise.
NEWS2 results were statistically significant , and first 65 EIND critical patients results were impressive.
I expect very good results from this study..And FDA never talk for few weeks about failing results , this I am sure about..
All IMO.