I’ll agree to disagree ATL. I’ve read thoroughly the Lerner Case. It is not a source for where the Hale was initiated or why. Therefore it is not a relevant source and it does not go into that.
The lifting of the partial halt, not halt, was a matter of law. The trial was basically done and the matter, whatever it was, was no longer relevant. The initial source and date of the German halt was the only source of information at that time that there was a halt.
I know my regulators and regulation matters, the FDA has to halt where a non-us regulator has halted a trial. So of course the FDA followed suit with a halt. I do not think you’re appreciating that.
But also a regulator cannot be u reasonable or arbitrary, so any kind of halt in the US without explanation, partial or otherwise, after a regulator insisted on that feature to the trial, and to end it would mean the drug likely would not be approved under our law at that time, that would not be enforceable and likely illegal without a very clear explanation that would also be transparent. Our law operates on precedents and other drug companies understanding why and how our regulator operates to avoid such circumstances. But in this case that reason is clear for the FDA, and that is because the German regulator, as indicated by the link I gave you, placed a halt on the trial.
That halt was as if 2015. There was no communication from the FDA that there was a halt or why. It is because they must do it, not because the FDA chose to impose it, and the only reason the FDA could lift it was because the issue was moot at that point.
No language in the Lerner case suggests that the halt was due to the FDA making the decision to halt. It is not explained, it is just a fact. A fact because of the rule/policy I mentioned above.
Another reason, at no time has the EMA lifted the initial partial halt that the Germans imposed. As per the link I showed you, the end points were revised, but the halt was not lifted in Germany. But it was again, never indicated that the trial failed. In fact, Germany gave the Hospital Exemption just before the partial halt, and the process for getting the Hospital Exemption is very rigorous and detailed and likely they looked at the data themselves to decide to make DCVax available to their citizens. The Hospital Exemption was never revoked, also indicating though NWBO did not decide to utilize the special designation because of it’s impracticality, that there was no issue with giving Germans DCVax-L. I also provided the various press releases and report on the halt at the time a few days ago. I do not have all those links handy, but I think the chronology and events are quite clear.
If the FDA imposed the partial halt, the Germans would then have lifted it on their website. That did not happen and has not happened. That is because it is irrelevant at this point and the reason, I believe, they did that was the placebo. And they are not going to “lift” that restriction anyway, assuming it is about what I think it is about.
I disagree that the FDA told anyone anything at the time or now, only with regulatory reform maybe, indirectly. That has nothing to do with statements on this trial about regulations that applies at that time. The FDA had its own policies and needed to change them to fix this, which I believe was about comflictingbregulator’s views and policies in a cross border clinical trial. That is what I believe is happening now, with all of the collaboration going on. They are recognizing the markets are global and these kinds of situations cause problems for good companies and good drugs when two regulators differ in their policies so much and one regulator can effectively spoil a trial globally because of another regulator’s requirements.
This kind of cross borders tripping up of companies happens all the time in other areas of law, I see it regularly in deals that straddle the US and EU. One can see it in situations that are ambiguous there and less ambiguous in some other jurisdictions that are not as well regulated as the EU and US.
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