dmb2,
One thing I know about the way the screening hold was handled is that there are marked differences in US and German law regarding human trials/experimentation. I think the FDA had to figure out a way to oblige the Germans with keeping out the last 17 SOC/placebo patients so the hold needed to continue until NWBO no longer would want to enroll the remaining patients which is when the hold was lifted.
I remember discussions on the board about a possible rift with FDA and I believe sentiment_stocks dug into the changes at the top around that time too. The head of the DSMB also blasted a certain biotech reporter for drawing negative conclusions about the L trial that he circulated through his media channels when the screening hold was announced which is even more historical evidence of what was going on then as well as today.
One other thing that was happening is that FDA guidance was in the process of change and there may have been a certain slowness about getting that started. I believe this also ties in to the whole May 10th debacle as the process for changing endpoints and tying into the exceptions for adequate and well controlled studies is quite a dance and includes the risk associated with updating the clinicaltrials site without a presentation to peers about the methods used ie May 10th, 2022 which the manipulators were all too willing to take advantage of believing they could get away with it. By the way, did you notice how quickly that site got updated after the presentation? That was not an oversight by NWBO, that was part of “the process”. I lament getting excited about the good news to be shared on that May 10th and forgetting about the risk to investors created by what the perps could and then did do back then. Best wishes.
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