You are absolutely correct Doc. This trial is going to set a new standard for how future therapies can be trialed and is following the guidance by the FDA at the end of 2018 regarding comparisons to similar cohorts/trials. The acceptance by the broader clinical/academic world is important as part of the complete package viewable to the FDA. Everything is included in their vision for approval and the clinical/academic blessing of the process is extremely important, even if not absolute. We have to remember that this trial will be the jumping off point of the next generation of clinical trials and it has to be as powerfully stated as possible as the scrutiny will be more immense than any trial in the history of clinical trials
That being given, I believe also that the MHRA will blow the other RAs out of the water quickly, and I mean VERY quickly once the data is in their hands. And that’s why I wouldn’t be surprised at the Lancet, the BMJ, or Nature being the Journal. As I said earlier the FDA is going to be under tremendous pressure if they’re not already looking closely at the available information they have been given. However, I still believe the data is being tweaked based upon recommendations by experts NWBO has employed; looking under every stone for possible questions academia and the RAs might have when seeing the full package of a brand new paradigm for the first time. You cannot rush this process or try to hurry the way a large amount of important data is to be condensed into a more simple picture for the world to comprehend and believe to be a valid analysis of the trial’s success.
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