You are correct about the FDA "smoke signals" showing they are essentially 'clearing the pathway' ahead prior to implementation of the final guidance however, we know for certain that NWBO will be using the RWE and new guidance relating to the new endpoints and comparing historical trials. NWBO will have to address the 'glaringly obvious' fact that there is a mismatch between what the clinical trial site states and what they will be comparing results to. Unless they have some official confirmation from the FDA then they will leave themselves wide open for attack. No new investor (especially a large investor) would risk their money until this critical point is clarified IMO.
I agree, but it depends on the holdup. If it is a reviewer that does not want to be officially ahead of the agency, or it could be that only UK guidance matters and in fact the UK is ahead of the FDA. So I agree, at this point, especially after the recent journal article, it may not matter. To some degree I have decided that is likely, but can’t say for certain. I do think that was a real reason for a delay.
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