My take on today's news is that it will very probably be near year's end, or later, before NWBO can commercially make DCVax-L with the EDEN unit. The question not answered is whether the company will pursue the approval of other regulators without it, and perhaps if they'd approach the FDA say 4 months before they believed it would be approved, thus the FDA inspectors would have 2 months before the PDUFA date to finalize an inspection of a production facility that includes it.
Frankly I don't see the company proceeding until they feel certain they won't be delayed by commercial production capability, but I don't know that with expansion of capabilities manually at Sawston that they can't propose initial use of that facility. It is up to the company on the approach they take, but I've got to believe that they communicate routinely with the regulators and get some guidance from them, but I don't know this to be a fact. If Sawston without EDEN cannot possibly meet the demands of multiple countries after UK approval, I don't see them proposing it for meeting multinational demand.
Today is the first time I can remember discussions of the dendritic cells clinging to the unit, rather than flowing through it, clearly they must have found a way of dealing with this, but didn't specify how.
Today's release certainly provides information that otherwise would have been pressed for at the Annual Meeting. I would suspect that the company may delay that meeting until they have an answer from the UK on the question of approval there. If I'm correct about that, it would put the meeting near mid year and I suspect they would effectively cover two years in a single meeting as mid year is actually the proper time to conduct them. This is purely speculation by me, for all I know they'll announce the AM very shortly.
Gary
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