Barnstormer,
There are clearly two sides here, the company believes that they can gain approval without further trials using the EDEN, the doubters, mostly bashers believe the only way the EDEN can be approved is by running additional clinical trials with it to prove it gets comparable benefits. I'm certainly on the company's side here, but it will take time to know who's right.
I'm frankly uncertain if Sawston in a purely manual mode is sufficient to gain regulatory approval everywhere, but again the only way to be certain is trying it. I would suspect that discussions between the company and regulators would indicate the regulators feelings about doing it.
Practically every drug in trials is made with different equipment for the trial than what's used for commercial production. I don't know why the same sort of comparison that's done comparing the trial product with the commercial product won't work for our vaccine, but is fine for the products made by the BP's and others.
There is no doubt in my mind that if EDEN never existed, NWBO could be profitable on manually made vaccine as the demand would be high regardless, and while it would cost substantially more, it could still be done very profitably. The reason Provenge largely failed for DNDN was the lack of demand, at the price it really wasn't that superior to other therapeutics. Perhaps if they could have automated it, and lowered the price, the demand would have been greater. That's not the case with DCVax-L, especially when the likes of Poly-ICLC and/or Keytruda are added. This is a paradigm shift in the treatment of brain cancer, and probably others in time.
I certainly could be wrong, but I don't think the regulators will delay making the vaccine available to the public for years by demanding additional trials to prove the EDEN unit when they don't do the same with the commercial mass production equipment which is often very different from the equipment that made the trial product. If they say, make it manually in the interim time they have to know that sufficient capacity won't exist to meet full demand for the vaccine. Who will decide who does, or doesn't get the vaccine.
Gary
