Thursday, January 27, 2022 10:56:04 AM
Gary, I appreciate you responding to my question, but my basic question was: Why do some believe that it was Germany and not the FDA who placed the partial hold on the DCVax-L Phase III clinical trial?
The only answer I can come up with is, because the EU clinical trial registry was updated to reflect the partial hold, and it was first noticed on the trial registry for Germany and then the UK.
But, as we all know now, in the US it is up to the Sponsor / Company (NWBio) to update the clinical trial registry. But, in the EU, the regulators update the clinical trial registry. Just like with the revised Primary and Secondary endpoints, NWBio also decided not to update the US clinical trial registry to reflect the partial hold.
Unless I am missing some evidence that others are seeing, I do not see any evidence to support that Germany was the first to place a partial hold on the DCVax-L trial.
The only answer I can come up with is, because the EU clinical trial registry was updated to reflect the partial hold, and it was first noticed on the trial registry for Germany and then the UK.
But, as we all know now, in the US it is up to the Sponsor / Company (NWBio) to update the clinical trial registry. But, in the EU, the regulators update the clinical trial registry. Just like with the revised Primary and Secondary endpoints, NWBio also decided not to update the US clinical trial registry to reflect the partial hold.
Unless I am missing some evidence that others are seeing, I do not see any evidence to support that Germany was the first to place a partial hold on the DCVax-L trial.
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