Brazen, let me ask what the company has lost with the delay? I really don't think we know. I believe it's even possible that on an annual basis more money is coming in as is. Why? Because as I understand it, compassionate use patients pay roughly a quarter million dollars up front. We don't know how NICE will structure payment for DCVax-L, but it's doubtful if it will be near a quarter million in the first year of getting the vaccine. For those living long enough it will probably be more than a quarter million dollars, but it will be spread out over a few years.
Of course, we don't know how many compassionate use patients we're handling annually, but we do know they're not all GBM patients so we're also building up anecdotal evidence of efficacy in a variety of cancers. If compassionate use patients annually are in the hundreds, we might not be losing significant money at all.
We need to remember Sawston manual production is limited to roughly 1000 patients a year. In the UK market there are roughly 3000 new cases discovered a year and I would suspect many from the last few years have properly stored their tumors and still could qualify for the vaccine. In short, the demand will be far greater than the supply until the EDEN is approved for commercial manufacturing. I'm not saying the delay has cost us nothing, just that we really have no idea what it's cost, or how many people are getting the vaccine under compassionate use. We won't make a fortune from manual production from Sawston.
Approval is certainly a great thing, but if by chance the company has convinced the regulators to expand the label, it would be far greater. Of course, it's only greater if you can deliver the vaccine and that brings us right back to the EDEN. It doesn't matter if the label's expanded to cancers where the UK has 10's or 100's of thousands of new patients a year if we can only make vaccine for 1000 patients a year.
I have no idea if the company is pushing for a larger label if they're trying to include say pancreatic, as we know a number of pancreatic patients have used it and anecdotally have benefits, or are they going all out and fighting for a purely tumor agnostic label. I believe if we got an approval for pancreatic cancer, in addition to GBM, many oncologists would go for off label use in many others of the deadliest cancers. My point is that until we have the EDEN, we're really not positioned to make big money because we can't treat enough patients. It would have been nice if we had approval a year or more ago, but if we did we'd all be harping on when can we treat more patients? Our price, no doubt, would have been higher so less dilution would have been needed, but if the difference is an approval for only GBM, or a label including more, I can understand why the company would fight for more as long as the regulator indicted that if they get enough information, they'll consider it.
It's purely speculation on my part, only the company and the regulators know what's causing the delays. I just keep thinking of the big ASCO display with Tumor Agnostic on it in 2024, as I remember it. The company was so positive about the vaccine being tumor agnostic that I believe they've tried to make that case.
Funny thing, if this approval had been based on pancreatic cancer, and the data looked as good, it would probably be accepted for nearly all solid cancers. Brain cancer is actually tougher as it has to deal with the brain-blood barrier, but it's different than others. Pancreatic is often used because it's so deadly, trials can be shorter, and if successful, regardless of the label, the drug approved for pancreatic will be used in many solid cancers and insurance will accept it.
Gary
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