Great find on the German patent denial and subsequent approval. This certainly seems to offer some evidence that the screening halt may have started with this... especially when you consider the time line.
I went back to the Oppenheimer Q&A section which you'd transcribed back in December 2014. Below is the link and it's featured up in the information section of the NWBO i-hub board.
Now I'm not suggesting that the automation isn't part of what's happening here. But I am wondering what you make of Linda Power's discussion of that at this conference? I'll post the entire transcript of the Q&A here (because it may be of interest to newer investors) but will highlight the area I'm referencing as relevant to the discussion. It's interesting to note that she mentions that word "today" when describing the manufacturing process of L... but she does seem to imply that it'll be a couple year process to get it to being fully automated. Or at least her answer could be interpreted like that. And a few years from the time of that presentation, dates to December 2016. Of course, she also states in this same Q&A she hoped we'd have data on L in the beginning of 2016, and not the middle. So... we're at the middle now with no data, as of yet. Timing still is a bit off, as usual.
Oppenheimer Q&A portion:
Moderator: I'm wondering if, a, anybody has any questions?
Conference attendee #1: Linda, on the 55 patient, that information arm, are you going to release any more data? And in particular, the breakdown between Rapid Progressors and Pseudo Progressors (psPD)?
Linda Powers: Umm, we haven't determined that yet. We may submit. Umm, we, we... If we do that, we'll do it in the form of submitting an abstract for a scientific conference, that type of thing. Conference attendee #2: You had... There were some litigation or some complaints, ahh about some of the data, I think. I can't remember exactly what that was. How did that work out?
Linda Powers: Umm, you mean recently?
Conference attendee #2: Yeah in the last or so.
Conference attendee #1 interjects: He means the investigation.
Conference attendee #2: Investigation, yeah
Linda Powers: Which investigation?
Conference attendee #1 interjects again: The law firms that announced the investigation.
Linda Powers: Oh. Ha! Yes.
Conference attendee mumbling comments.
Linda Powers: I think that there are at least eight different law firms that have announced that they're investigating us. The reason they're investigating us, in their own words, according to their own press releases, which by the way they've issued multiple times, is because we... it was inappropriate for us to issue ... to release umm information about any interim results. Such as the interim results that I just showed you here, so we intend to continue.
Conference attendee #3: There wasn't one, one person who jumped on the bandwagon of that, those little bit of law firm complaints, right? Or filed a lawsuit, whatsoever?
Linda Powers: No to date there is no law... to date there's no lawsuit. If there is a lawsuit we will vigorously defend it, because that criticism is ...ahhha, ummm...I'm trying to think of a word that's publishable in a family newspaper.
Random conference attendee calls out: Bogus.
Linda Powers: Bogus! It's bogus.
Random conference attendee calls out: Outlandish.
Linda Powers: Outlandish is another good word for it. Yes.
Conference attendee #4: Question with respect to PIM.
Linda Powers: Yes?
Conference attendee #4: That it's a two stage process as I understand it.
Linda Powers: Yes.
Conference attendee #4: Have you or are you going to be filing an application shortly?
Linda Powers: We haven't said anything publicly, so umm, stay tuned! Yes, for everybody else - you're a very well-informed shareholder! - the early access to medicine scheme, the EAM scheme, in the UK, is a two-stage process. So we completed stage-one, and that was the PIM designation. It's very British. Promising Innovative Medicine. That was the intensive evaluation of the technology. And the potential benefits of the technology. And the potential toxicity. The second stage. There's a second stage. And the second stage itself has a couple of stages. First you have to go through a pre-submission process. Make submissions. Get evaluated. And you have to get invited to apply for the second stage. Then you, then you apply for the second stage, and that triggers then a multi-month long further process, which principally focuses on manufacturing. Because is you read the criteria, the decision-criteria, on the MHRA website. MHRA is the regulator agency of the UK, like the FDA of the UK. Umm, the decision-making criteria for stage-one are: Is the disease serious? Are the benefits of this technology potentially a breakthrough? And, is the toxicity worth it? The criteria for the second stage are those same three criteria again; and: how good is your manufacturing? Are we satisfied with your manufacturing? And let me tell you, that for us is, a, a massive sweet-spot. Umm, what we had to go through to satisfy the German regulator to get the Hospital Exemption was very heavily focused on the vigor and quality of our manufacturing. So we've been through that drill and aced it. So we're ready for that.
Conference attendee #5: I have a question about... it pertains to the manufacturing. So let's say, your personalized treatments... what is your capacity? How many of those vaccines, with preparation can you do? And what's your time? (mumbling)
Linda Powers: Yeah. We talk about this. Yeah, we talk about it all the time, because if this technology continues to perform in the way it has been so far and if it's going to applicable to most solid tumor cancers, you're talking about, not 10s of thousands of patients, you're talking of 100s and 100s of thousands of patients for whom it could be a fit. Umm, today the process, umm, the process is to, for the first product, DCVax-L, it's a manual process. For DCVax Direct, it's already partially-automated, the automation system. The answer can only be automation. Right? But, from a business standpoint, there's a point in which the lines cross. Right. We want to get to market and get the product to patients, as quickly as possible. Right, so we're going to do that the way that we're making it now. But, we're busily working, as is anyone who thinks about the future with a cell-therapy product, about end-to-end automation. And one of things about end-to-end automation is, is that it's both a capacity issue, a scale issue, because once you're fully automated in the end, you can virtually treat any number of patients. The other thing is, what people don't often realize is, it's going to further revolutionize your product economics. Why? Because when you make it by hand and there are steps that are open to the air, the whole facility has to be sterile, like a semi-conductor facility. It's massively capital intensive. And that's the biggest part of the finished cost of goods, is those indirect cost of that clean room infrastructure. Once it is automated end-to-end, that all goes out of the equation, because you just have rows and rows of these machines in a warehouse space. So you couple that with the batch manufacturing, and it's a step-change in terms of further enhancement of the economics. And so, everyone is busily working on automation. Umm, we think that's a couple-of-year process from where we are today. And we're working from some of the biggest and the best from all over the world.
Conference attendee #5: And another question that I had, is that given the timeframe that you sketched for the DCVax-L, it looks like you probably will have data in, let's say in mid-2016? What are you thinking the.
Linda Powers interrupts: No, no, no, no. No, well, if you know if the patients, umm, depending on the patients, of course. No, we think it is more like close to the turn of the year. Like the beginning of 2016, not the middle.
Conference attendee #5: Okay, okay.
Conference attendee #1: that's because the patients are doing well.
Linda Powers: But it's a prediction. Right? Any of these things are not set in stone, whatsoever, and everybody needs to kind of remember that.
Conference attendee #5: But then, how are you thinking about the regulatory process element? You touched on that, but how are you thinking about commercializing it? Are you going to... because it may be a huge effort given, you know, how many patients you have... Umm
Linda Powers: Are you asking if we're going to do it ourselves or if we're going to partner it? That's always the elephant in the room, so I'll just say it for you. Umm, certainly for sure in brain cancer we're going to do it ourselves. In the whole United States the American Association of Neurosurgeons, AANS, it only has about 3000 surgeon members. And of those, a few hundred are brain surgeons for brain cancer, right. You have a target audience of a few hundred. You have a sales force of 20 people, each of them covering 25 doctors. Bingo, you're there. Right? And that's the U.S. market, that's pretty big. We've given a lot of thought to this. Also, today, if you think about it, what would a big-Pharma bring to the table with this type of a product? Right? They don't have any manufacturing capabilities for a cellular product. They don't have any distribution infrastructure for a cellular product, especially a frozen one, which goes in frozen dry-shippers. Which by the way, there are all kinds of practicalities to this. We ship the product in what are called, 'dry shippers.' Which if remember the little robot in Star Wars, R2D2. It kind of looks like a tall R2D2, right. It's powered by liquid nitrogen. The temperature is stable for at least 12 to 14 days. So if you ship it, and somebody loses it on a loading dock for 3 or 4 days, no problem, you're fine, right. So there's a lot of practicality. Pharma hasn't developed any of that. Right, umm, so really the only thing that Pharma could bring to the table would be, their checkbook. And, umm, we'd rather not be bought.
Conference attendee #1: Linda, do you have any comments to make on duration of effect? There have been reports, I'm not sure if are true or not, Allan Butler's cancer shrunk to the point, where it's operable? You recorded a month time, I think, at first connotation 29 percentage reduction in size. Can you give us any kind of ... well, first of all, is the report on Allan Butler correct? Second of all, is there any shrinkage in the primary tumor, and the sub-connotation?
Linda Powers: Umm. I hope, I hope Allan Butler will be umm indulgent about any HIPAA issues. Cause I think he's said on messages boards, like publicly, that yes, he's had surgery. Right. Otherwise, I wouldn't compromise a patient's privacy. Right? But, I believe Allan has said on messages boards, and publicly, that yes, he has, and he has had surgery. Right. So that was, that was very exciting. And, you know, in terms of duration of DCVax Direct, I mean, the patients haven't even finished the treatment regimen yet. In the pre-clinical animal studies, which is worth mentioning, those animal studies, where you saw the eradication of the tumor, umm and it went to zero. We treated several different cancer types and multiple groups of animals and between 80 - 100 percent of animals in the various groups cleared all of the tumors from their body - both the ones that were injected, and the ones that were not injected. And to Larry's question about duration, the other piece of important information about immune memory was that those mice were re-injected again, with the same tumor cells that had established the tumors in the first place; and, they were re-injected 60 days later. Which, if you are familiar with mice, you know that's a long time in a life a mouse. Sixty days is a long time. And, none of the tumors established a second time, indicating immune memory. So, memory is one of the. And you are all familiar with that, you get your tetanus shot once every 10 years, right, you get your vaccines, and you have memory in between. So if you can mount an immune response effectively in the first place, we are hopeful, but we'll have to see, that we'll see immune memory in people, similar to what we saw in the animal studies.
So, okay, we're 15 minutes overtime. I better wind-up. Thank you everyone for coming. It's been really great. And stay tuned.
