Congratulations to SI and team. It didn't work out as planned however you took initiative and had a go. Also the results show that we have at least saved some lives , perhaps even better the possibility of improving the outcomes for the survivors but we must first look at the data to ascertain whether we did or not.
Can any one explain why we need to wait 60 days before the data is unblinded. Obviously the results of this trial will need further data to support full approval ( not to sure about NIH , they seem to be incapable of running a trial with out major issues. ) I am no exspert on statistics however it would appear that we are running at about 30% survival benefit above control. So is it not now time to open the data and start to work out what is going on. The Dr's can carry on blinded. We would have a group of at least 150 patients that have completed 60 days of follow up. That is a huge group of patients for what now could be considered several P2 trials. This would allow a small confirmatory trial to get underway rapidly that may be considered adequate for EU. A well run trial of 20 patients randomized and enrolled over no more than one week and unblinded at 30 days would give far more credible data to add to what we have already generated.
Remember all, if you don't have a go you will never know.
Good luck all. CLBP?
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