The EMA listed the relevant regulator as Germany, even though the MHRA also was in the EU at the time and should then have been listed as also a relevant regulator at that time. The UK was still fully in the EU.
Honestly, don't care where it originated, but I do not believe it originated with the US or the DSMB. Placebo's are not as controversial here as they are in Germany, though perhaps they are now in the sense that the FDA recognizes they handicap trials and is moving toward open trials with synthetic placebo arms quicker than they are really wanting to say. I've not seen the company clarify where the halt came from, and I'm an avid watcher. Please provide more info.
And also, I do not believe it was the FDA because the FDA insisted on the placebo arm from the beginning and I think they would only lift that requirement with proof of efficacy, not because the placebo arm was not living as long. I do not think they would see the placebo arm as being disadvantaged and I do not believe our laws would have a partial halt, for undisclosed reasons, in that manner, for any other reason except safety and there is absolutely every indication that safety was not an issue, neither was manufacturing because that would be an expression of a safety issue and they'd literally have to stop giving DCVax. It would be an issue that would need to be fixed immediately or full halt.
And ultimately it was a regulator that said, though it was their primary regulator, that the partial halt was lifted. If it was DSMB, the way it came out, the posting on the EMA website listing Germany, and then the lifting of the partial halt by another regulator, because basically the trial was done with enrollment, none of that would make sense in the context of what would otherwise be a voluntary event.
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