Doc, the example you link to was halted by the FDA for serious complications, which is and was public information and would need to be 8-K’d and then the second one was voluntary because after reopening the trial by lowering the dosage, they still had the same problem. So they effectively ended the trial “voluntarily”.
I agree, if there were safety issues due to DCVax, those would be obvious without unblinding. It would also be a public event and could not be kept under wraps and quiet. And it would necessarily be 8-K’d.
This is not that situation and I’ve explained how it would not work as you’ve suggested, and I just can’t agree that it would be voluntary, yet have it listed on the EMA website as it was and still is listed if it was not a regulatory event. I’ve concluded it probably was not a negative event. I think some have said that LP has hinted similarly that it might not actually be a bad thing. I have come to my conclusions that if it were the bad things listed under regulations for the FDA to impose the halt, it would have to most likely be public info, certainly if it were negative, and if positive, I believe most likely the reasons I have given, but I think the Germans would be more likely to have raised the issue of the placebo arm because the Germans would likely have more issues with that and the FDA not so much, so long as patients were getting the standard of care, as the FDA had insisted on the placebo arm AND being irrational in that fashion and taking it out, before there was enough data to accelerate the approval, and potentially mess up the approval, would mean a massive lawsuit that no one would win. Technically the company would win but it would not be positive. A judge can’t approve a drug. Doing a trial over again is a loss even if it was a win in court. I believe the FDA knows all of this quite well. And they would likely have allowed the trial as it was, unless one of the negative things I mentioned occurred and then, as I said, it would be public info.
Instead I believe the Germans imposed a partial halt, did not need to explain it fully under their rules, because it could unblind, and the FDA literally had no choice but to honor such a halt by applying it here as well. That’s typically how such cross border issues are resolved, especially with regard to regulations for medicines. If a regulator makes a determination re “safety” or “ethics”, our regulator is going to want to know the full details and how they were resolved.
Apparently the only way they could be resolved is that when the DMSB said the trial was completed, what with 12 or more patients short, or 17 (I do not recall), and then the FDA agreed to release the halt, but the Germans/EMA still lost it, because their designation was not dependent on the FDA’s determination. I believe it was the original determination, and the FDA, which has certain other requirements really can’t impose a hold on a trial that is not in progress. So THAT might be the “voluntary” notion you are getting at. That came at the end of the trial. Not during the partial hold period.
Watch out for word salad served up to smooth answers to questions. I’m theory that is voluntary, but it’s more complicated than that and it’s not really. It’s an agreement to end the trial and not push, and besides, who is going to join a trial that needs 12-17 more placebo patients? It’s a practical impossibility.
AI
Market Data 
Markets 
