Advent happened to use DCVax-l production to prove commercial licensing for its facility. This may confuse some, but is certainly a necessary step, and it greases the skids for any remaining modules in the MAA (preparation) submission process for DCVax-l, imo.
My understanding is the only thing advent manufacturers is DCV. (Correct me if I’m wrong on that).
From what has currently been disclosed, this is correct.
It is a company owned by LP basically built for the sole purpose of pumping out DCV in large scale quantities.
All but certain as well, yes.
And by all counts, everything is going exactly as it should on the manufacturing front.
However, the point I’m making is that once again, people are saying the commercial cert guarantees approval because they wouldn’t give the cert if DCVax weren’t going to be approved. Though I believe MHRA approval is very highly likely, the cert is not evidence of that. It is a cert for all biological manufacturing. Not just DCVax. If it were specific to DCVax then yes, the “certain approval” would be very valid. But it isn’t. If DCVax is not approved, Advent will still be able to manufacture many other biological compounds commercially at Sawston.