I agree, hopefully the demand will result in at least the UK authorities expediting approval of the EDEN unit, provided NWBO is receiving completed units from their contractor. We know that they do have limited capacity in London. Frankly I don't know if the US would approve a deal that had CRL making the vaccine here and exporting it to the UK before the vaccine is approved by our FDA.
In my mind I'm wondering if any of the European authorities could piggyback off the UK approval without a formal submission. I believe when the UK was part of the EU such a submission would have applied to the entire EU, but I don't know that it was the case. Germany seems most eager to move on using DCVax-L, if individual European countries can approve for only their country, it wouldn't surprise me if Germany was the first.
By the way, I figured that day 90 would be the very earliest that we could be in an approval window, with us at day 78, we'd be less than two weeks away. Not saying it will happen that quickly, just that I can't imagine it happening earlier than that. More likely we go closer to day 150, but I believe it will happen somewhat before then.
Gary
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