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Thanks for the advice ATLnsider. I read some of bio’s responses to you on this subject a couple years ago, which in my view, seemed rather dismissive and condescending. There certainly is some basis to the theory of using poly I:C in the manufacturing process of DCVax-Direct at least, and potentially even for DCVax-L down the road.
I agree that poly I:C was not used as an activation agent in the first clinical trial with DCVax-Direct, (it was BCG and IFNy). However, I think many other agents, including poly I:C, were also studied by Northwest Bio in earlier, pre-clinical work with Direct. I speculate that because of the UCLA studies, and the impressive results seen with poly-ICLC in combination with DCVax-L, and a potential in-licensing agreement with Oncovir, that poly I:C could be further studied as a activation/maturation agent in the manufacturing process for DCVax-Direct going forward. As I said in my previous post to you, using poly-ICLC in the manufacturing process for DCVax-L is far more difficult due to the culturing method used for DCVax-L, but I think it’s at least potentially possible. I do agree with you that the combination of DCVax-L and poly-ICLC is the plan going forward for all current and future studies of DCVax-L, but I think it will be administered as separate injections for now.
Some people are unwilling to go out on a limb and potentially be wrong because they always have to be right, so I appreciate reading your (and other’s) reasonable speculation and research that may be out of the box, even if it’s not always correct. I also respect bio and agree with most of his posts, and I appreciate his arguments against the naysayer’s false claims over the years, which have since been proven false and irrelevant as clinical trial results were published, and the marketing application finally submitted. I generally don’t put longs on ignore, but simply don’t read their posts, and I rarely read his posts these days, or reply to him, but that post caught my attention.
bio, thanks for the clarification. I think a lot of misunderstanding and misinterpretation can happen on these message boards because full thoughts are often abbreviated, context is missing, or all mashed up as ae Kusterer does. I don’t read his posts so I didn’t realize (but probably should have) that he Frankensteined my post onto others.
bio, the poster that you responded to was ae kusterer, who we all know, reposts other people posts without good reference. It was my post that he reposted, which I also put in my response to you as reference. You basically claimed in your response to him that part of my theory, which states that poly I:C could be used as a maturation /activation agent for DCVax-Direct was a false theory with no basis.
In the part of your post that I bolded, you said that poly-ICLC can’t be used as a maturation agent, or used in the manufacture of any DCVax product including Direct, and that it can only be administered separately as an adjuvant. That is false and you are wrong, as I just showed in Northwest Bio’s patent. I’ve seen you twist an argument, and go off on tangents, to make it seem like you were not wrong many times, just as you are doing here. This is exactly why I said that I don’t want to waste my time on this.
Really bio? You respond to ae kusterer, but not to my original post?
Doc, I personally don’t think the MHRA will inspect Charles River Labs' (formerly Cognate’s) or Fraunhofer’s manufacturing facilities, since they are not currently being used (or immediately planned) for initial DCVax commercial production.
I think, but I’m not sure if the MHRA is like the FDA, in that they will generally schedule a pre-license or pre-approval inspection of the intended commercial manufacturing facility after the midpoint in the review process, and request to view all phases of the production operations for the selected product under review in the marketing application.
Shutting down operations of a GMP facility for construction, maintenance, cleaning, and disinfection is complex, but routine, and would not effect anything unless a significant change to the plant and equipment occurs, which would usually require requalification. (except that a pre-approval inspection obviously could not be scheduled during the shutdown)
ski, are you asking if I think the UK inspectors need to look at the manufacturing sites used for the clinical trial, since only Sawston is indicated for commercial manufacturing at this time?
If so, my answer is no, it shouldn’t be necessary as long as there were no potential red flags raised during the review of the clinical trial patient records or manufacturing records from those sites that were sampled. However, that may not be the case, and not all inspectors/regulators are equally thorough, or think the same. Generally, the first marketing application and regulatory review for a new drug, or molecular entity, is more thorough and takes longer than subsequent marketing applications for additional use of an already approved drug. (since the appropriate nonclinical and manufacturing data may have already been reviewed by the Agency in the initial application)
Visits to potentially obsolete manufacturing sites is certainly one area of the 150-day accelerated review process that could, and probably will be cut to expedite the review from the standard timeline. As additional commercial manufacturing sites are added, they may be inspected at that time.
Right ATLnsider, as you indicate, in the UCLA combination studies with DCVax-L, the poly-ICLC is administered separately as an adjuvant. However, in the early studies with DCVax-Direct, it was used in the manufacturing process, which increased the potency. (poly I:C, or its derivative, poly-ICLC is included in the Direct patents, and the more recent hyperactive patents)
ski, the pre-approval inspection is performed to assure regulatory authorities that the facility listed in the marketing application can manufacture the product, and that the data submitted is accurate and complete. Regulators will look to confirm that:
* The site conforms to the application
* The site demonstrates manufacturing reliability
* The site can scale its operations
* The site uses suitable and adequate analytical methodologies
* The site is producing authentic and accurate data
* The site is in full CGMP compliance
I have full confidence that the Sawston facility will pass the inspection as they have previously, regardless whether it’s the same inspectors or not. Although it’s probably the most important, Sawston may not be the only site visited, since other manufacturing sites were used for the clinical trials. (Cognate in Memphis, and Fraunhofer IZI in Germany) Obviously those other sites haven’t manufactured a product for Northwest Bio in a decade, but scheduling these visits in a timely manner could be more of an issue in my mind, and it seems impossible to predict if they even will, or the timing.
Thanks for the clarification ATLnsider, and apologies that I got it a bit wrong.
Yes hank, the "manufacturing and clinical trial site visits" are the inspections that are referenced on page 23 of the recent 10Q. And yes, I think they are intended to be completed within the second 70 assessment period, however, as I included in my post, the MHRA is still backlogged and may not be able to complete this in the 150-day assessment timeline as intended. They are potentially all clinical trial sites and manufacturing sites directly related to the clinical trial and the MAA, as well as any current manufacturing sites (Sawston) that will be used for commercial production, and not the Eden Flaskworks system, which I believe is separate from the MAA.
I don’t think it’s opposite things flipper. As I said here, the marketing application review is an interactive process where the company is sharing requested information with the various assessors and inspectors, and I think this process is what Northwest Bio spent months preparing for, and discussed in their press release. But because Northwest Bio used the language “request for further information” in the following press release, I believe that some may have misconstrued this process with an official RFI letter, which is sent to the company after the first phase of scientific assessment, if more information is needed that is not included in the marketing application and supporting documents.
beartrap, to market a new drug or biologic, regulations require adequate and well-controlled studies that distinguish the effect of a drug from other influences. And for regulatory approval of combination regimens, it is necessary to demonstrate the contribution effect of each monotherapy to the overall combination. This is why I believe that Northwest Bio’s first marketing application did not include other adjuvants.
ATLnsider has speculated that Northwest Bio is using poly-ICLC as a maturation and activation agent in the manufacturing process of DCVax-L and therefore, thinks it will be included in the marketing application. While I believe this manufacturing method may have been studied, I believe it was with DCVax-Direct, and not DCVax-L. Northwest Bio did not use this manufacturing method for the clinical trials with DCVax-L, so I do not believe the first marketing application includes poly-ICLC as a maturation/activation agent either.
As I’ve said, other than a few potential anecdotal cases, I don’t think Northwest Bio has enough (real-world) data to seek regulatory approval with Poly-ICLC at this time. I’m not aware of ANY actual evidence that studies with a significant number of patients were performed using this combination (or manufacturing method) for compassionate use, so this seems to be complete speculation. As far as Dr. Ashkan using it for compassionate use and collecting real-world data; I’ve seen a number his presentations about DCVax, and not once was poly-ICLC mentioned. The only data that I’m aware of with poly-ICLC, is the UCLA data, which I believe Northwest Bio intends to confirm through their own clinical studies,(both DCVax-L and Direct) as soon as possible. (after the first regulatory approval and in-licensing agreements are finalized) They might even run studies to determine the optimal method of combining poly-ICLC with DCVax; as a separate adjuvant, or as a maturation/activation agent in the manufacturing process.
BTW - I’ve read some of dstock’s posts, and in my opinion, his speculation seems rather far-fetched and not based in reality. For example, I don’t believe Merck or any Big Pharma company (except NW Bio’s CDMO, Advent) is constructing a manufacturing facility to manufacture DCVax, nor did Merck and Northwest Bio secretly run the combination trial for colorectal cancer. I highly doubt that any Big Pharma companies are currently hiring positions related to Northwest Bio, nor do I think that Northwest Bio is secretly applying for approval with poly-ICLC. Everyone is free to speculate and believe whatever they wish, so I mean no disrespect, but I’m just stating my personal opinion on this because you asked.
I think the extremely slow pace of DCVax development, and lack of communication, has led many of us to speculate that certain developments have occurred or could be happening behind the scenes. This very rarely proves true, and in most cases, Northwest Bio at least mentions, or alludes to their development plans in SEC filings or press releases, and announces significant milestones when they are achieved.
I think the 1st quarter 10Q was positive, and nothing in it has changed my opinion that the timing of marketing approval seems most likely in the 3rd quarter. It reads as though the application was complete, and there was not a request for further information after the first phase of assessment. Just like the application itself, Northwest Bio also seems well prepared for the manufacturing and clinical trial site visits that occur in the second phase of assessment.
Despite requesting a 150-day accelerated approval pathway, and being fully prepared for the rigors of assessment, Northwest Bio is not in control of the timing of the process. The most recent MHRA Performance metrics indicate that the MHRA is still considerably backlogged, even though they hired a number of new assessors last spring and summer, and hired a number of new inspectors late in the fall, and continue to hire inspectors currently.
Beartrap, you can be certain that one of the in-licensing deals that Northwest Bio has been negotiating, is with Oncovir for Hiltonol (poly-ICLC). We’ve discussed before about Northwest Bio’s patents and plans for a 10x more potent form of DCVax-L, which is the combination with poly-ICLC. This is the next generation of DCVax that Northwest Bio discussed in the 10k, and other filings.
I think it’s also very likely that another in-licensing deal is with Daiichi Sankyo for Pexidartinib (CSF1R inhibitor). These are the adjuvants that Dr. Liau has trialed at UCLA, which have shown tremendous results. Northwest Bio added Dr. Liau to the Scientific Advisory Board to assist with these registrational trials, and I think they will begin as soon as possible.
What is not very likely however, is that the marketing application that has been submitted to the MHRA includes either of these adjuvants. I’m firmly in the camp that says Northwest Bio will need to first receive approval for DCVax-L as a mono therapy added to the current standard of care. I also don’t believe that Northwest Bio has enough data to seek regulatory approval for the combination with poly-ICLC at this time, but I think it’s certainly in their near-term plans. (They may use the new standard of care, which includes DCVax-L, as the comparator arm)
Really Doc? A thousand patients a month? Could you define the timeframe of “about ready?”
That’s about 33 batches a day. Do you understand what that would require? How many Flaskworks systems, Qualified Persons, etc.?
beartrap, that’s the hard part. When is “close to approval?” I don’t think compassionate-use patients or Northwest Bio will actually know when marketing approval is coming, until the day the decision is made, so it may become increasingly difficult for those patients to decide whether to pay themselves and begin treatment in the coming months, knowing that marketing approval could be coming any day.
I do think the health ministers at the NHS understand the desperate situation that glioblastoma patients would be in, if compassionate use is no longer allowed, when DCVax receives a commercial license, especially if a decision from NICE doesn’t follow rapidly. And I agree that there will certainly be pressure to act on cancer patient’s behalf, if that’s what you meant by being “forced.” It seems reasonable to think that a funding source like the Cancer Drug Fund could be used to help some patients, and this would allow Northwest Bio to cover the manufacturing costs in the interim period between commercial approval, and a NICE reimbursement decision.
When DCVax receives reimbursement, I think they could continue to manufacture using the manual method in a limited capacity until the automated Flaskworks process is approved. Northwest Bio has always put the patients first, so of course they would continue to make the treatment available, but I personally don’t see large scale manual manufacturing initially as you are suggesting could happen with patients flooding in, but who knows.
beartrap, I’ve never seen a treatment that was approved for compassionate use, which later received commercial approval, but I’m unsure if this situation is truly unique. Once DCVax receives commercial approval, I doubt any more patients can be accepted into the Specials program, as it’s only for unlicensed medicines. For patients that were already accepted, they would have already begun treatment and paid for the initial treatment doses. (imagine being that last patient who had to pay for his own treatment, and just discovered that DCVax received commercial approval - ugh!)
I know the NICE assessment process starts earlier so there isn’t as long of an interim waiting period after a drug receives a commercial license, before a reimbursement decision is made, but I think it still could be up to a couple months after commercial approval. The Cancer Drug Fund may cover the cost of some treatments in the interim period until a NICE reimbursement decision is made, but there are limits, so I doubt they could cover everyone if there truly was a rush of patients.
I have reasons to think that the plan has been to start commercial manufacturing with the automated Flaskworks process, even if it occurs a few months after approval, but I’ve admitted that could be wrong, and I’m open to other possibilities. Everyone is certainly free to have a different opinion and believe whatever they wish.
flipper, I don’t think senti was really saying “that marketing approval for DCVax-l is now awaiting Eden approval,” or I wouldn’t have agreed.
I’m also not suggesting that “the NICE reimbursement process is not currently running parallel.”
I’m suggesting that all three timelines are running in parallel. I should rephrase that part about all timelines being independent though, as of course the NICE reimbursement is tied to the marketing approval.
As I’m re-reading this, I’m also not suggesting just about everything else in your response. You’re just putting words in my mouth, so I’ll just leave it there.
meirluc, Northwest Bio has always said they want this treatment available to everyone, not only those that insurance is willing to pay a high price for, so that requires automated manufacturing. Along with the Flaskworks automated manufacturing process, Northwest Bio (Advent) has also been automating final product testing methods (assays), for a completely digital manufacturing and release process that will allow a much more rapid batch verification and final product release. I believe this may be all tied together, so there may not be an interim step to manufacture commercially using the manual method for a few months, and then switch over, and then negotiate a different price based on a different manufacturing method.
As far as the timing of everything, I’m just speculating as I see it, and could be wrong, so we will have to see how it plays out. I do think many investors here don’t fully understand or appreciate how difficult it is for a small company like Northwest Bio to bring a novel cell therapy treatment to market, and be required to pioneer and orchestrate so many moving parts, especially with contractors and backlogged regulators. It’s far easier to sit in the back seat (with a very limited view) and point fingers at the wouldas and couldas along the way. (I’m not saying that you’re doing this meirluc)
I keep hearing this same line repeated - that all these cancer patients are dying because it is taking so long to bring this treatment to market, and somehow, that is seen as Northwest Bio’s fault. Let’s get something straight: The length of time it has taken is not all Northwest Bio’s fault. And neither is all the dilution that resulted from the short attack, and being forced to raise capital at prices well below $1, with warrants and other unfavorable terms attached.
Remember that Northwest Bio was on track with multiple clinical trials for both DCVax-L and Direct, attending investor conferences, trading on the Nasdaq, receiving investment from institutional investors, before it was attacked, frivolous lawsuits brought against them, and a false narrative created and spread, to make to appear as if “DCVax doesn’t work, the phase III trial failed, and management is misleading investors.”
The fact is, that Northwest Bio’s stock had risen rapidly to a high of over $12 which gained the attention of nefarious hedge funds, who saw an opportunity to make some easy, risk-free money. They hired someone to write a false “research report” as a basis for them to perpetrate a short and distort attack on the stock. These hedge funds are the ones responsible for starving Northwest Bio of the necessary resources required to bring DCVax to market in a timely manner, and depriving cancer patients of this treatment.
Linda Powers and Northwest Bio have survived the attack and overcome numerous hurdles in their path to bringing this novel cell therapy to the commercial market. They have almost solved the major bottlenecks that would prevent the large scale manufacturing and mass distribution of this cell therapy, and are now finally on the verge of regulatory approval. I have full confidence that when the time comes for commercial manufacturing, the best choice will be made, whatever that is.
I agree with senti, that the delays in the submission of the marketing application, delayed the timing of the approval of DCVax, which made it months closer to the potential approval of the Flaskworks’ process. I also agree that the wording of the press release seems to back this up, particularly this line:
beartrap, my answers to your questions about the Sawston manufacturing facility:
For starters, the total size of the Sawston facility is 88,345 square feet on two floors.
eagle, I highlighted that the podcast host, Dr. John Fortunato, has an advanced degree in bioethics, and an interest in clinical ethics in neuro oncology, so as an interviewer, he of all people, should be aware of the conflicts of interest and questionable ethics of the doctors that he is interviewing. It would have been a much more credible and interesting interview if he had done his homework on the subject, and brought it up. Right? This is why it may be ironic to some, but it just seems sad to me that he is either ignorant of this, or worse, complicit.
I thought it was obvious that the comment that I made to “get a clue” was meant for him (to be more aware of the ethical issues). But now that I’ve had to explain all this, perhaps it wasn’t so obvious, and I apologize that this wasn’t more clear.
The podcast host’s academic interests include clinical ethics in neuro oncology. Some might call that ironic, but I think it's pathetic. Get a clue man!
A prognostic biomarker that can identify glioblastoma patients who won’t benefit from chemo . . . and the study involved researchers from King's College London and a collaboration of 11 neuro-oncology centres from across the UK. Hmmmm, interesting timing.
Professor Keyoumars Ashkan and Dagmar Ingeborg Turner reunite, three years after making world-wide headlines
Back in 2020, Professor Ashkan and the team woke violinist Dagmar Ingeborg Turner during the operation to play the violin, acting as a guide to ensure no damage was caused to the crucial areas of the brain that controlled her delicate hand movements.
Prof Ashkan explained: “Dagmar had expressed it was vital that we preserve her ability to play the violin, and as doctors we’re always wanting to advance science to improve the quality of our patients’ lives. “I am truly honoured, and grateful to Dagmar, to have had the opportunity to perform surgery in this way.”
The pair reunited as they visited their appearance in a new exhibition at London’s Hunterian Museum on the power of surgery; Transforming Lives.
https://www.kch.nhs.uk/news/kings-consultant-neurosurgeon-and-patient-reminisce-on-using-the-violin-to-help-surgery/
There are further expansion plans for Sawston, (which may be occurring now) but it appears that Northwest Bio/Advent are being rather secretive about not only these expansion plans, but even the most recent phase II expansion as well. In regulatory filings, all that has been disclosed was that phase II was completed in the 2nd quarter last year, but not the number or type of cleanrooms, or their footprint.
I was hoping to glean some information about this expansion from Catapult’s Cell and Gene Therapy Manufacturing Report last year, but apparently Advent did not provide that information for the 2023 survey, so the report just used previous data for Advent. In footnotes it says, “*** 2022 footprint data has been used,” and still only shows 7 cleanrooms at Sawston. With regard to future capacity and expansion plans, it simply stated:
A potential leukapheresis bottleneck is real, but not right now as Doc implies. It’s a significant business opportunity that will very likely be addressed by the industry when it’s necessary, so it’s really a non-issue in my opinion, but something to be aware of. Lykiri (inadvertently) brought the issue to the board’s attention last year.
Chiu, I dunno about a “$10/share” value today, but maybe fairly soon. I think similar cell therapy companies like Kite and Juno, that were pre-revenue and pre-approval, had market caps of four or five billion before their buyouts, which is probably a reasonable value for Northwest Bio at this time. I think NWBO would probably be closer to that valuation if the stock had institutional investors and was trading on a national exchange, and not being manipulated on the OTC. The reason those companies were valued at $10-12B is because they were acquired at a premium; a price that also valued their future revenues. I think I’ve posted this before, but there’s an interesting article about Gilead’s acquisition of Kite and how that buyout price was achieved here.
There are many ways to value companies, and I think comparisons to similar companies is a fair method, however, I agree that the comparison of Kite to Northwest Bio begins to fall apart when considering the size of their respective markets, and their ability to capture it, which is why Kite’s buyout price is only a good starting point for Northwest Bio’s future value. It took Kite nearly 6 years to achieve $1.5B in annual sales. Northwest Bio’s future revenues are likely to be considerably higher than Kite’s, not only due to a much larger market, no competition, and DCVax’s ability to safely combine with many other agents, but also because Flaskworks’ automated manufacturing will allow much faster growth.
I think your argument here is solid, but it’s probably not enough to counter the continual manipulation of the stock as you suggest. Unfortunately, true demand for the stock is capped on the OTC since there are only retail buyers, and the price can be controlled with as little as a few million in capital. It seems that Northwest Bio understands and this, and doesn’t seem particularly concerned right now about the stock price or countering the false narratives like they used to, (except with the medical and scientific communities) while the stock trades on the OTC. I think this is all going to change in the near future though.
I think regulatory approval is the lynchpin which enables other events to occur, similar to the JAMA journal article finally providing validation of the science and trial (which allowed the lawsuit to be filed against the manipulators). Approval by the MHRA will provide further legitimacy of the science, and de-risk the company for critical investment by large investors and potentially a partner(s). And we know that Linda Powers has plans to list the company on a national exchange which will attract institutional investment, analyst coverage, publicity, and Northwest Bio will finally gain the value, and exposure that the science and company deserves.
In hindsight, knowing now that the MHRA’s processing of clinical trial applications was so backlogged, and yet during this period, Northwest Bio was somehow able to to receive a surprisingly speedy approval for the pediatric trial, (a process which normally takes a year even without backlogs) it seems far more impressive. I think this bodes well for the current marketing application timeline.
To say that Merck’s shelf registration is connected to Northwest Bio is a bit of a stretch, but I can’t deny that it would be necessary. And you either didn’t look very hard, or maybe didn’t know what to look for. (newman sure doesn’t)
https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/ff0e430e-39e6-42c8-aeb4-9a8c1b7d4b92.pdf
ilovetech, I’m not sure how closely you've been paying attention to the defendant’s posture and bullying tactics, but everything that I’ve seen from the defendants thus far, leads me to believe that they will play this out, and are not in any hurry to settle.
flipper, I think many of us (including management) have long suspected that some of the parties involved with financings over the years were at least partially involved in the manipulation of the stock. It won’t be known who all the responsible entities are, and whether there was any coordination among them until discovery, and even then, it may be difficult to get the whole story, as there will be attempts to disguise their nefarious activities and obfuscation of facts. Northwest Bio has their own record of the relevant financing dates to pin some of it down though.
Other than the reputational damage, loss of institutional investors, analyst coverage, and illiquidity of the stock, another major ramification of de-listing from a national exchange is the reduction in access to capital, both terms of the equity and loans, but also the quality of the lenders. It’s pretty well known that there are a number of shady lenders who prey on small companies on the OTC.
Anyone who has watched, or traded in NWBO, has probably seen some odd trading, and has also seen the price fall right before the close with unusual regularity. It’s probably unlikely that it’s being monitored though, as authorities are stretched thin, and there’s much less oversight on the OTC.
Laura Posner is very well aware of certain stock manipulation techniques that may be familiar to us, and we seem to witness in NWBO, like “spoofing and layering,” and “banging the close.” Perhaps exposing trading records and other information will shed some light on this for authorities, and potentially even exposing “inadvertent” mislabeling of trades, or algorithmic collusion, and other less obvious nefarious activities, so it will become too difficult for them to “turn a blind eye.”
Exactly, minimize financial exposure. This has probably been in the works for a while . . .
#AMC and #Gamestop investors remember this;
— The Butcher of Wall Street Marcel Kalinovic (@BossBlunts1) December 1, 2023
Credit Suisse didn't report ANY short positions from February 2015 through April 2022.
More than 7 years‼️
Now #UBS is stuck with the legacy costs from both #CS and #Archegos.#Blackstone is closing a fund that offers investors… pic.twitter.com/cFP9Frf5cT
ski, I think there are still many unanswered questions about DCVax. I know that all of us are hopeful that the budgetary constraints that have burdened this company will be over soon, and they will finally begin more clinical trials to get some of those answers.
This reminded me that I sent a note about this study on brain tumors and circadian rhythms to Dr. Liau a few years ago, (I didn’t have access) and she replied that she was interested.
Thanks Lykiri, interesting indeed. He’s courageous, and I wish him the best. Count me in.
I wouldn’t worry GermanCol, you still have cred. Most of us here have highly developed FUD detectors, and can determine fairly quickly who are the sincere, credible posters. I think you’ve established your credibility and distinguished yourself from the usual suspects. Flipper doesn’t speak for everyone, and he sometimes mischaracterizes people. I remember he labeled me a pumper and a day trader because I mistakenly thought the Flaskworks development work was further along than it actually was. Carry on.
ATLnsider, I don’t pay much attention to all the negative noise makers on this board. I agree with your point that even at $250K, DCVax is relatively inexpensive compared to all of those other cell and gene therapy treatments you illustrated. And by stretching payments, it lowers the annual cost to governments to a much more manageable level.
Your Casgevy example demonstrates exactly what I was saying; governments are simply not able to cover all eligible patients for all of these therapies, so they are forced to limit the number of patients they will cover. I think we agree that in order to continue to receive insurance coverage as the patient numbers grow, Northwest Bio will have to keep prices at manageable levels for government budgets, so bringing and keeping production costs down, will be critical to scaling DCVax beyond GBM.