The constant appearance of many ubiquitous viral variants must be taken into account when assessing trial data. Different versions of the virus are occurring at different times and places. Some versions may have higher mortality and or contagion levels than others. This could be the reason for variations in outcome at different facilities. What is effective in on setting may not work in another. Can any trial address this issue or give results that the FDA with its bent towards scientific rigor ever accept. It may be that anecdotal evidence from many ethical medical professionals is the best society or science can do. The FDA should accept that time is of the essence and use some common sense not just "scientific rigor", as 200 American lives are lost every hour they prevaricate. If people at the FDA negligently delay or deny Americans access to any curative treatment they personally and the FDA should be held accountable. I hope and pray that LL is made available soon to America and the World as an effective therapeutic for many indications.