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Advent books the revenues because this is not a regular drug sale. It is under the Specials Program and Advent is effectively serving the role of a compound pharmacy in the UK, putting together a treatment that is ordered. There is no “royalty”. There is only fee for services in terms of NWBO and Advent. The fees are in their contracts, but the revenues are ultimately NWBO’s revenues and Advent will get some fee for services. However, there are baseline costs for licensing the facility, managing it and staffing it. It would be similar for their previous CDMO, Cognate, but much more up front costs because it would be at Cognate’s own facilities and it would require allocation of lines that otherwise would go to manufacturing other drugs.
In this instance, NWBO owns the facility, and they have a bit of a symbiotic relationship at this time. Advent provides manufacturing services for regional requests as a part of the low cost financing NWBO received for Sawston to be turned into a manufacturing facility. Advent has a small portion of that facility as well, which can be used when idle, for other requirements and then otherwise is prioritized for DCVax-L.
Anyway, there are costs up front and we literally have no idea how many patients are able to pay, out of pocket, up front and how much. It appears the company has broken up those amounts just to get it all started, and the revenue they may be getting so far may simply be enough to maintain the facility and reduce their monthly burn for having a fully licensed manufacturing facility up, ready and at its required clinical levels even when idle. THAT is always otherwise a substantial cost for companies and I honestly think they do a poor job of explaining just how clever they have been with this, but I get how shorts turn good always to bad, so they just let the circumstances speak for themselves. They have a fully capable factory, that they effectively have possession of, for their purposes, but the costs are shared regionally, because of the regional financing arrangement and requirements. Substantial risk is pushed aside, while they wait to become licensed to market and sell in the UK. Hence the application to the MHRA, which is allowing this drug you claim to be a scam, to be sold at full price to the citizens of the UK, and the UK has stern consumer protection laws and drug regulation. They do not allow such a drug to be provided to their citizens without careful consideration of its likely benefit, even when it is pre-licensed. While the decision is deferred also to the patient’s doctors, they would not allow snake oil to be manufactured domestically, in these circumstances, which require quite a lot of regulation even though it is pre-marketing license being granted.
The end result is the local provider gets paid, manufacturing that compound or drug. NWBO is not licensed to “market” just to allow its facility, and CDMO, to provide the drug, based on that schedule. I am sure we will eventually hear what that requires in terms of payment, and recognition of income. But your speculation appears bizarre and off. Advent has not become a licensed marketer and manufacturer of the drug. No one is marketing it. If the complexity of the situation confuses you, then speculating about it only makes it worse. NWBO owns all rights, Advent is only the CDMO hired to create, license, run its plant and manage the manufacturing processes. Those things do cost money however and this is a facility prepared to manufacture for global demand. For the marketing application to MHRA and ultimately to other regulators, it has to be at the immediate ready to fulfill those requirements.
And as for the UK, given the friendly disposition, a situation I have not seen for any other drug or cell therapy before in any major market, I think the company has the regional financing authority funds and dispensation to deliver DCVax-L to patients, manufactured at a globally licensed facility in the UK, mainly because they have immense confidence in their relationship with the UK regulators. That PIM designation spoke loudly and continues to speak loudly even if it was, otherwise, not apparently all that valuable given the program it slotted into at the time. It symbolized a very positive disposition related to DCVax-L and I believe that disposition has continued to be signaled along the way by all the special circumstances surrounding DCVax-L and patient access to it. It doesn’t mean it is a sign they are already approved. That is a different process and follows its own rules. But it does show positive disposition toward the company and the CDMO and great confidence in their competence and the drug, I believe, and patient and doctor confidence in it. But out of pocket, it is always going to be a challenge for any kind of cutting edge oncology drug like this. People will always need insurance and companies need full rights to scale and meet that demand covered by insurance. That is the nature of this market.
Well, given the post at the end that you shared, I would think he would not be posting until an MHRA decision comes down.
Wow, the shorts are so desperate to get this down and get the volume of selling up, so they can cover, that they are posting articles from as far back as 2010, and raising issues so old, but pretending they are current or trying to make them “current”… it’s incredible. Anyone visiting SHOULD be able to see through that nonsense.
Night is always darkest before the dawn. Shorties may have their way, but events can change on a dime.
And if you want to start only with newly diagnosed and recurrent Glioblastoma, I was able to coax multiple AI’s to generate a rough estimate and nGBM and rGBM based on nGBM cases and recurrence rates. Both came to the same crude but straightforward number of 6080 patients per year. X .45 eligible for surgery, again, crudely, 2736 patients per year
2,736 patients per year x 250,000 crudely, and again my larger estimate goes through and cuts and cuts and does a variety of things to consider the implications of approval also on the market estimate of likelihood of additional approvals and other market sizes, and again, as I said there, these are crude numbers not about actual patients treated by the potential size of the market …
2736 x $250,000 = $684 million revenue.
X 15 for potential market cap, and this does not include all the other brain tumors I think they will ultimately be approved for… $10.26B potential if one were only li tied to UK and used your typical very crude multiple calculation… I used dollars.
Again not an estimate of actual market cap. Given that markets would recalculate likelihood of approval in commonwealth, treaty countries, the U.S., EU and Canada, and the relevant sizes of the various markets, market cap should grow in anticipation of such potential approvals, of course discounted by possibility of rejection, which should, that point be decreasing as a risk factor. Claim what you want… but the reality is, all we can do is consider possibilities, and that’s a good range of possibilities. Not so tiny. And I do suggest people consider the other post and those can of course be refined down further as well. I did some of that in the post. And of course they are rough ideas and numbers and can be further refined and boiled down as I did here. I used the HE potential market size, as I think doctors will want this available for all brain tumors asap. I think the label will be extended, given side trial results like the one planned to be published in Nature, which includes a broader category than just GBM patients. And those patients do incredibly well.
With real world data reforms, extending the label should be possible and the company and UCLA seem likely to have good data to accomplish that on approval. Whether first year or thereafter, I have no opinion. But markets typically look forward in such instances, and again, will estimate likelihood of approval in other markets and the potential markets as a part of a reasonable estimation of future and then present market cap and so will potential buyers or partners consider such matters, and how they could expand markets not just for DCVax-L also, but also for their drugs like Keytruda or Poly-ICLC.
Agreed.
Thanks so much.
I did not say off-label. What makes you think that is off-label?
Brain tumors. The Hospital Exemption was that broad. And they did not even ask for it nor did they have the data now available.
That is the size of the market. The cost for DCVax-Al per month is far below current alternatives. I did not say they are paying $20B. Market cap is a multiple.
There was no off-label assumption.
My point is the SIZE of the market. You can grouse all you want about whether the UK will pay. We will see. The point is it’s about a $3.00 per share market for numerous reasons.
1) it brings along the likelihood of approvals across treaty and commonwealth nations, certainly those in their treaty group as well as Canada and Australia are likely at least;
2) UK and US approvals are usually very much in sync, so it means the market has to presume at that point US approval is more likely than not;
3) EU approval must also be taken as very likely at that point as well. And it’s just a hop from the EU and North America for patients that can afford it and read the news.
Tiny market it is not.
Thanks so much Flipper. Yes, one thing, the UK foreshadows larger approvals and it’s not so tiny when one considers the potential larger number of possible brain tumor patients that could be approved, not unlike the previous approval related to the Hospital Exemption and PIM designations.
Thanks so much WideEyed! I find this site so hard to locate posts generally, once you post them. I should have saved t myself. You’re a lifesaver!
Thanks Chiugray. I thought he has, despite immense challenges, always been fair. I agree that one cannot say 100%, generally, but I like the odds as well.
A few weeks ago. One of my rare posts where I talked about market size and potential market caps. Had a fair number of comments. It was posted specifically in response to the notion that shorts love, "but the UK is so small"....
My market size post related to the UK was taken down. Not sure why. It was completely on point, not about anyone else. But it is not locatable. If anyone else finds it, maybe I am incorrect, but it speaks to the issue with regard to some forums, the frequent impermanence of positive articles about the company.
Probability of approval, interesting article. Worth a read.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173645036
That is not about progression doc and you’re describing treatment for both treatment arm and non-treatment arm placebo. On recurrence, there was no required non-treatment protocol or requirement that doctors not determine if true progression were occurring. This is one of a few legs upon which Ex’ claim fails. Moreover, the placebo arms that recurred. In the concurrent trials were selected to have the same prognosis, after receiving the same care. So living longer on receiving DCVax-L is still statistically relevant.
As for our friend, he just tries to make this all seem much more complicated and obscure than it has to be to cloud understanding. And of course he is not in medicine nor a doctor nor an epidemiologist or statistician. At least that has never been claimed.
I don’t pump. I just ask people things like, what is your interest and why do you spend 24-7-365 bashing on this obscure board when you do not own it. This honest question irritates people like you who do not disclose their interests and you call THAT “pumping”. You call it “pompous”… but really, you simply refuse to disclose and you hate being asked to be transparent like those of us who disclose our interest in EVERY post.
Most of the time it is because such people are vulnerable, large shorts and they work at firms… that short. And disclosing that would open a can of worms…licenses and other things being what they are…
He says a lot of things. He is inconsistent. Never the same story from post to post to post… and far too much emotional insanity. Nothing justifies his behavior or crazy tone. Far beyond normal. Unstable.
Now in this post you say you “once owned it”… again, seems like these posts are incredibly unreliable in terms of the disclosure of your interest…
I note you said here, “AND” I own IOVA…
And this post seems intended to confuse…
And you post on this obscure board for what reason? You’re promoting IOVA?
That doesn’t seem to be your purpose. You just like to waste your time and ours? Seems unlikely too given the persistence and the extreme emotion you express here.
Let me state this more clearly, because I was thinking it through as I wrote it.
Not necessarily the statement is for purposes of the initial determination for the trial involving nGBM. There is no such limitation on the diagnosis for rGBM.
For the determination of recurrence the trial was required to be consistent, for statistical purposes, even though it was learned during the course of the trial that the standard method alone was flawed and not valid for pseudoprogression. This is an unfortunate part of the ridiculous formality of trials, that you’d have to continue to diagnose in this manner, in order to remain consistent, knowing, in fact, that you’re getting a false result. It is not the requirement for patient care and it would be medical incompetence to presume recurrence when you know it hasn't happened. Further, that is really only for patients in the nGBM context. Upon recurrence, doctors would certainly do their best to be sure that was the case. Further, such patients this applies to, this analysis, are ONLY the STANDARD OF CARE patients, NOT the treatment arm. Pseudoprogression was a problem primarily for immunotherapy patients. But again, there is no limitation on diagnosis and scanning for rGBM patients after they've recurred, that would be a bizarre situation and unlikely given the many care centers and doctors participating who generally have no interest one way or the other. You might presume the doctors are incompetent with the standard of care, placebo patients, but it's highly unlikely.
Once the patients were diagnosed as recurrent, it would be medical malpractice to diagnose such patients as “recurrent”, when they were not, in fact, recurrent, if you have the knowledge to diagnose that they are rGBM.
There was no original protocol for the rGBM patients, so they will discuss that I am sure with the regulators. However, there is also no reason to doubt the survival results compared to patients with the same or similar diagnosis in trials that happened concurrently. The reality is, they were compared to similar patients with similar diagnosis in concurrent trials. There is no difference in that circumstance. And again, these were the placebo arm, standard of care patients, where pseudoprogression was not typically seen previous to immunotherapies.
Remembering that pseudoprogression difficulty in diagnosis happened in the treated arm for immunotherapies but also that limitations as to diagnosis are only for statistical collection, not for care, helps to keep one honest. Once patients recurred, they could get all kinds of additional care, including Optune, and that is registered in the details presented in the JAMA paper. The rGBM patients were getting the standard of care only, so pseudoprogression likely was not the issue it was in the treatment arm and even if some of them are, again, you’re comparing to patients in a standard of care, getting the same exact care, in concurrent trials. No difference. So the survival results are comparable.
This only works to confuse people who cannot think this through.
Not necessarily the statement is for purposes of the initial determination for the trial involving nGBM. There is no such limitation on the diagnosis for rGBM.
For the determination of recurrence the trial was required to be consistent even though it was learned during the course of the trial that the standard method alone was flawed and not valid for pseudoprogression. This is an unfortunate part of the ridiculous formality of trials, that you’d have to continue to diagnose in this manner, in order to remain consistent, knowing, in fact, that you’re getting a false result. This is what shorts are most consistently about. And the company maintained that for purposes of the diagnosis of recurrence for nGBM.
However, once the patients were diagnosed as recurrent, you do not know if additional review of their disease happened, but that seems awfully likely. It would be medical malpractice to diagnose such patients as “recurrent”, when they were not, in fact, recurrent.
There was no original protocol for the rGBM patients, so they will discuss that I am sure with the regulators. However, there is also no reason to doubt the survival results compared to patients with the same or similar diagnosis in trials that happened concurrently.
Further, remember that pseudoprogression difficulty in diagnosis happened in the treated arm, the rGBM patients were getting the standard of care only, so pseudoprogression likely was not an issue and even if some of them are, again, you’re comparing to patients in a standard of care, getting the same exact care, in concurrent trials. No difference.
You claimed just a few posts ago that you own shares... so you just called yourself a loser. But again, no one in their right mind can believe you because you clearly tell incredible lies with great emotion, which is why they are so incredibly obvious. Further, you spend ALL of your TIME here with LONGS, trying to convince LONGS with obvious deception. There would be no need to do so if 1) you actually held shares; or 2) this is a failed company. You would not need to do it if your interest were not completely counter to longs. As I said, your lies are so obvious, and yet you continue, and it's tiresome because we know they are not meant for us, they are meant to influence stray visitors. We know you're lying. You know you're lying. You know we know you're lying.
What happened is obvious. I don't need to speculate. The regulator would not have allowed them if any of it were untrue. As to whether it will be approved, I think it is HIGHLY unlikely that a safe treatment, for an orphan disease, with the kinds of results that they can show across the board in many patients, side trials as well as this trial, with patients living way longer than anyone sees ever... it's unlikely it gets rejected. That you think it will be I think is bizarre and unhelpful and then to say you've got shares and pretending to be a fellow long... it's obviously unbelievable. Anyone who so obviously lies, cannot be trusted with regard to their claims about what will happen and what has happened. No one in their right mind would believe you.
That’s not what happen d and they were working with their regulator. OS was always a secondary measure, the problem was the regulatory mandated crossover that depleted the control arm, not the measure, and the regulator came up with ways to address this, with external control arms. Fixed notions about bias are also easily dealt with the they came up with, likely in complete coordination with the regulator, hiring outside noted statisticians and epidemiologists who were third-parties and maintained complete blindness.
The reality is, short throw pebbles and you sit with shorts throwing those pebbles virtually all night every post, except when you protest that you “own it”, just like every shirt that needs that legal fig leaf to claim they are a “shareholder advocate” and not manipulating share prices for easy money.
Swing traders and short hedge funds “own” it too, doesn’t make them the same as a long. “Own it” is particular language.
Nonsense.
No, survival is NOT a shortcut. And a new trial wastes lives, money and entire companies and the FDA is reformed to avoid exactly that kind of unnecessary, false traditionalist nonsense that has absolutely no point but to keep only the largest companies in the game.
For taxes.
No one lies. This is your claim and if they did, sue them. Lying is a crime. Alleging they lie, lying, without proof just to affect investor interest aught to be a crime too.
All facts in my post. You have nothing but to shrink and pretend.
Quit bluffing, it was a phase 1 / 2 safety trial, no safety issues. They found systemic response and many patients surviving far beyond when they were supposed to survive. But it was not calculated to give an optimal treatment, as a safety trial.
The patients were unable to get other treatment and were effectively assigned to go to hospice if they could find no other options. They only injected one tumor even if the patients had many. The result was most patients lived longer than expected and some seem to have continued living indefinitely. They had a variety of horrible cancers. They gave different amounts I believe, and different versions of the vaccine.
“Primary Outcome Measures:
Number of patients with adverse events [ Time Frame: 6 months ]”
“Subjects with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which primary treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment, with the understanding that DCVax-Direct is not intended as a treatment of last resort.
Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice.
Must have completed at least one recent treatment regimen in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden.
Any steroid therapy >2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter = 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
Adequate hematological, hepatic, and renal function,
Adequate blood coagulation parameters
Life expectation of >3 months.”
“Abstract
Purpose: Dendritic cells (DC) initiate adaptive immune responses through the uptake and presentation of antigenic material. In preclinical studies, intratumorally injected activated DCs (aDCs; DCVax-Direct) were superior to immature DCs in rejecting tumors from mice. Experimental Design: This single-arm, open-label phase I clinical trial evaluated the safety and efficacy of aDCs, administered intratumorally, in patients with solid tumors. Three dose levels (2 million, 6 million, and 15 million aDCs per injection) were tested using a standard 3 + 3 dose-escalation trial design. Feasibility, immunogenicity, changes to the tumor microenvironment after direct injection, and survival were evaluated. We also investigated cytokine production of aDCs prior to injection. Results: In total, 39 of the 40 enrolled patients were evaluable. The injections of aDCs were well tolerated with no dose-limiting toxicities. Increased lymphocyte infiltration was observed in 54% of assessed patients. Stable disease (SD; best response) at week 8 was associated with increased overall survival. Increased secretion of interleukin (IL)-8 and IL12p40 by aDCs was significantly associated with survival (P = 0.023 and 0.024, respectively). Increased TNFa levels correlated positively with SD at week 8 (P < 0.01). Conclusions: Intratumoral aDC injections were feasible and safe. Increased production of specific cytokines was correlated with SD and prolonged survival, demonstrating a link between the functional profile of aDCs prior to injection and patient outcomes. Clin Cancer Res; 24(16); 3845-56. ©2018 AACR.”
Not true. Novel claims often require a complex back and forth with a court and defendants before the course of a case is fully set in motion. They are going for something that has not been done before and I believe they will be successful. But the reality is that bold claims can require some back and forth like what is occurring.
Like before it went to $12?
Your insistence that validation does not exist, despite the evidence that it does, and the nature of the trial, disease and apparent very favorable leanings of the U.K. given access in the specials program, is no surprise. It’s just that you have been consistently wrong, in such matters and all you have is really old nonsense.
No, but I would not expect anything other than something so vulgar and excessive as your opinion.
I am not supporting or attacking him. Your behavior is nonsensical, bizarre and has no logic and you’re attacking the orderly structure of a company in which I am invested.
I am not here to facilitate bizarre or bad behavior. And I am here only as another investor. Not here to advocate for you to be invested. If you don’t like something, you don’t have to be invested. No one is begging for you to be invested.
Actually, I did go through the ownership details. I clearly know way more than you. You’re just throwing around false implications and nonsense. Bizarre behavior.
Your knowledge is not critical to the internal decisions of the company on such matters. Some of his shares may not have been allocated your attack on this, randomly, bringing up things unrelated from 2007, when he was not a board member and involving regulatory matters, clearly you’re screaming all over the board without ANY actual information, which is bizarre. Seems like a fake effort to create noise around trying to oust a board member. And that, as I said, usually suggests interests trying to get some sort of leverage. But, in this case virtually all the points are without real information, are falsely made by implication, not facts, are extremely dated, and are literally bizarre. Strange. Not rational.