10Q --> "DCVax-Direct manufacturing and product development work and the preparation costs for the launch of two clinical trial programs, one in the US and one in the UK, as well as expansion of the ongoing Phase III trial in the US, and increased manufacturing of DCVax?-L for the Phase III trial."
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TZOR --> "Do you think they mean to indicate expansion = more people enrolling with the initial population figure maintained?
or
Do you think they mean to indicate expansion = increasing the total amount of enrollment so that they can meet stat sig, as was referenced in the prior webcast?"
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I think that one fairly decent possibility is that the talk of expansion here and in the past is expansion in the US to make up for lost trial patients in Germany and the UK, due to a conflict with the Hospital Exemption. That explanation would fit into a difficult standing puzzle.
The one thing that wouldn't fit that model is that they said the trial would continue in Germany... or did they say Europe? So, maybe that is to be a different trial. But that would not mean lost time in Europe necessarily, because the PEI may be willing to use all the data from the FDA trials. Just not the other way around if there is no placebo in Europe. And there is no pressing need for approval in Germany. So just a small delay to the US trial due to having to move those planned final enrollments. I just think of it like Germany got approved early so now the trial will finish out here instead of over there. Not sure about the UK. I think we will know more soon. Probably will go the route that Germany went, as many have speculated.
Of course there are other possible explanations, but I believe this is a reasonable one. And I don't see this one as horrible news... if true. They might worry, however, that it could be perceived as bad news.
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