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Friday, May 07, 2021 7:05:32 PM
The entire discussion is nonsense at this point. This is a reg/rule that is intended to encourage behavior. It is not something that any regulatory agency at this moment is charged with enforcing and for which there is no strict enforcement. One of the reasons for that is that the FDA views this process as CONFIDENTIAL, and there are securities laws as well that might be disturbed by aggressive use of this “rule”. So there is an incredible degree of deference to the relevant companies and trial managers as to when or how these are updated.
No one is going to force them or penalize them.
This was discussed last year. ExW took an absolutist approach that the lack of updates was a fraud. He thought the NIH was under FDA, and that they were an enforcement agency. When I cleared all of the confusion that he wrought about that, he went quiet for a year or so... and now, just like all the fud these guys throw at the wall constantly, it is back again.
No one is going to force them or penalize them.
This was discussed last year. ExW took an absolutist approach that the lack of updates was a fraud. He thought the NIH was under FDA, and that they were an enforcement agency. When I cleared all of the confusion that he wrought about that, he went quiet for a year or so... and now, just like all the fud these guys throw at the wall constantly, it is back again.
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