dennisdave,
What is well understood is that Linda Powers, Dr.Linda Liau and NWBO have been learning, improving and schooling everyone that gets in their way because they are leading the way to change. This includes waiting on regulatory changes needed to adjust for the technology NWBO and others are bringing to the table. This and improved manufacturing have been being worked on since 2014-2015. The specifics are just now starting to be made known. The need for new guidance has been talked about for a while now. MHRA and others did something about it but make no mistake, NWBO has been creating much of the need for this change while investors have been waiting for others to catch up to understanding the science and manufacturing to catch up with the need from expected demand for the business model to work well. Best wishes.