You wanna play with FIRE?, page-133

I'm tired of people saying the trials failed.
they didn't, some of you really need to stop being so ignorant.

CHF didn't meet the primary endpoint of re-hospitalisation but it smashed the secondary endpoints at 60% reduced mortality how is that a fail? - I see this either getting approved straight up or approval with another confirmatory study.

COVID ARDS - trial ended at the third analysis because DSMB said "may not reach primary endpoint of 43% reduction in mortality"
firstly, since April, the UK has 10x the amount of COVID cases
and 50% less deaths than it did in April, the standard of care is increasing to the point where it makes it hard to distinguish what is, and isn't working

43% was also optimistic, MSCs role in repairing the damage don
by COVID is what the secondary endpoints will be looking at, again not a fail if the trial shoes impressive lung repair

Also, the DSMBs job is to ensure the trial continues its course (this point 43% reduction in mortality) the fact it ended means that in the third analysis it did not reach this number, so it's ending the trial, we may still may see 20-30% reduction in mortality while accelerating recovery (which is what we saw during the pilot study, i.e days of ventilators)

srGVHD - again, not a fail, FDA want a "confirmatory study" before approval, who knows? We might see conditional approval based on the TA meeting