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AEK, I would consider it a great success if as many as145 compassionate care patients were treated between 5/10/22 and 6/14/23. It stands to reason that most of those patients were treated after reception of the MIA (3/20/23-6/14/23). I am looking forward to the next quarterly in August that will hopefully provide us with the pertinent information.
AEK, it is hard to believe that during the past 13 months (5/10/22-6/13/23), about 145 patients were
treated via the "Specials" program because only relatively few of those patients were treated before the reception of the MIA (3/20/23).
If I am correct, Sawston was judged to have the capacity to treat about 450-500 patients per year or roughly 112-125 per quarter.
Treating a majority of the 145 patients in the last 2.5 months (4/1/23-6/13/23) would imply that Sawston is already operating at full capacity. If true, that would be wonderful, but is it true?
Perhaps it is true and part of LG's show aims to telegraph sub material information indirectly via pathways like mathematical hints.
The next quarterly will let us know whether or not the specials program has recently been greatly accelerated at the Sawston facility or whether LG's statement has lead us into a rabbit hole.
Calmed down meirluc to calm OncoJock: How likely is it that DCVax-L which greatly invigorates our agnostic immunological mechanism's ability to destroy glioblastomas, will not basically function identically (agnostically) to destroy solid tumors located in other parts of our body?
I believe that it is extremely likely and explains the optimism of many of us on this MB.
Newman here is the part of Kelly M. Hotchkiss' article (just presented by Lykiri) that I have problem with.
Gary, I have to be honest with you and will tell you that I cannot guess what will be the sequence of steps that the company will have to take towards approval by all regulators. Furthermore, depending on unforeseen events, that sequence could be subject to substantial changes.
It is of course logical to believe that first and foremost, we will have a submission of the MAA but thereafter there could be different paths leading toward the final goal of approval in all 4 jurisdictions.
What I strongly believe is that NWBO has done everything to ensure that the vaccine will be approved by the RAs and has never purposely procrastinated or delayed the process leading to approval and commercialization. I doubt that another staff could have done better. Perhaps a number of individuals on this MB, some of whom may have been successful in bringing new products to the market, would have made some better decisions than the company but OTOH, they could have very well made other, more serious mistakes that would have ended up causing the company to fail.
Maverick, while I also don't expect anything this coming month or the month thereafter, I don't exclude the possibility that something very good (i.e. MAA submission) could occur during that time interval.
lack of expectations that good events will happen within a certain timeframe does not prevent them from unexpectedly popping up.
[quoteSo far, all data presented is consistent with better resection allows patients to live longer][/quote]
Would that mean that the approximate 24 months mOS of the 99 member "intend to crossover" group, the 19.3 months mOS of the 232 Treatment patients and the 16.8 months mOS of the ECAs was mainly dependent on the extent of tumor resection?
That means that somehow the 99 patients that were subjected to the most extensive resection were placed in the "intent to crossover" group whereas on the average, less tumor was extracted from the 232 patients in the treatment group. Finally, the group with the least extensive resection were of course the patients in the selected ECAs.
IMO, even an organized group of super talented Houdinis would not be able to orchestrate that kind of a fraudulent trial?
HL, no science or trial showing new progress or promise for treating brain cancer patients had been featured or named during the Moonshot program. Apparently that was the program's policy and does not in the least reflect on the enormous potential of DCVax-L.
Ilovetech, for Oncovir , 3M$ is a lot because soon when their patent runs out that company will be worth next to nothing. With 3M$ in their pocket and in addition as a part of NWBO, the ex Oncovir staff is going to do just fine.
Maybe Merck gave 3M$ to NWBO thus enabling NWBO to buy Oncovir before both entities are swallowed up after the MHRA approval, by Leviathan Merck.
hankmanhub, I don't believe that NWBO will necessarily have to acquire Oncovir from a BP that had recently bought that small company because NWBO can purchase Poly ICLC from other manufacturers. This is especially true if the BP that had acquired Oncovir, will demand a very high price. . I believe that by the end of this year, NWBO will be able to acquire Oncovir at a reasonable price.
You are very welcome Dstock.
dstock, I strongly suspect that the Oncovir staff is already well aware that their only product that has for a long time been just one of many immunological stimulants, is about to share center stage with a revolutionary immunotherapeutic anti cancer product (DCVax-L).
I believe that it was sometimes today that one of our MB posters mentioned that despite the pending patent expiration of Poly ICLC, Oncovir has recently been on a hiring spree. Assuming that is correct, why the hiring spree right before the patent expiration?
Maybe the pending success of DCVax-L+Poly ICLC (combo trials) has given Oncovir's product a lease on an expanded after life with NWBO's DCVax-L?
Yes hankmanhub. Any BP could easily buy Oncovir but unlike NWBO, it cannot extend the Poly ICLC patent and thus will face competition from all the other companies that are capable to manufacture Poly ICLC.
Only NWBO can extend that patent as an integral part of its DCVax-L vaccine.
You are right Gary. Right now, NWBO does not have the funds to buy Oncovir. However, I think it will not be too long before the company's fortune improve and they will be able to make that purchase.
Dstock, I would like to add that once NWBO buys Oncovir, the pending expiration of Oncovir's Poly ICLC patent would not constitute a problem because as ATL has been pointing out, Poly ICLC is an essential and integral component of DCVax-L . Hence Poly ICLC will be something like an unofficial patented component of the patented DCVax-L vaccine.
Oncovir's fate as a company will therefore become irrelevant while their main product persists. As a ridiculous analogy I will mention the fate of the Neanderthal species that are extinct but some of their genes are still an integral component of the genetic makeup of most human beings on this planet.
Dstock, you are right that no sane professional would join such a company. However, I am not suggesting that at all. While the Oncovir company has no future by itself, their product (Poly ICLC) may have a very bright future because much greater quantities of that product will be required once DCVax-L expands its tentacles beyond glioblastoma and begins to treat various solid cancers.
Oncovir's personnel can save themselves and the patent of their main product by joining NWBO. In other words, NWBO can buy Oncovir and Oncovir will disappear within NWBO. The advantage is that the cost of Poly ICLC would be very much reduced if NWBO owns the manufacturer of that product. The cost would most likely be much higher if NWBO would have to buy this product from another manufacturer.
Merck could buy Oncovir+NWBO but will probably not buy Oncovir alone because without controlling NWBO's DCVax-L, the Poly ICLC's patent could not be extended. Of course Merck could buy NWBO without buying Oncovir and then buy the generic poly ICLC from any source that manufactures this item.
OTOH, because poly ICLC is an integral part of DCVax-L, NWBO could buy Oncovir, then extend the poly ICLC patent and thereafter have the huge advantage of not only selling the Poly ICLC as part of the vaccine but also sell Poly ICLC itself to any customer that needs it. Finally, NWBO will also eventually require an awful lot of Poly ICLC because a lot more DCVax with Poly ICLC will be required for treatment of many additional solid cancers.
Question: If Oncovir's Poly ICLC patent is soon expiring, why is Oncovir hiring high caliber personnel? Does Oncovir have any viable plans after the patent expiration of their major product? Just wondering.
mike00h, I don't see how a US default would not have the consequence of negatively affecting NWBO and its introduction of the DCVax-L treatment. Of course, if a default becomes a reality, the American as well as most of the world economies are going to take a hit.
I very much hope that the USA will be able to avoid this calamity.
Thank you ILT. I hope that you are right and I am waiting with the rest of the world to find out what is really going on. I am waiting for a pleasant surprise.
ILT, are you counting on the 14th amendment to save us from the debt default?
line 3 post 594795 should read "except for NWBO"
I gather HL that you believe that neither a future pandemic (like COVID-19) nor a USA default on its debt would seriously delay the introduction of new technologies into the Market. That means that besides NWBO, the introduction of new technologies by other small companies did not experience any delays when faced with the COVID pandemic and will also not be affected by a USA debt default.
I BEG TO DIFFER.
Default on the USA debt should be a chief concern to all of us. If this calamity becomes a reality, it will affect all of us in some way and in addition, may very well postpone the ability of NWBO to bring the DCVax-L treatment to the market. To date I have not read anything on this board that has mentioned this potential problem
Welcoming any ideas and comments on this subject.
The DCVax-L results are super stellar. Which trial has demonstrated roughly a 24 months mOS of an "intend to crossover" rGBM population? We can compare that comfortably to the average mOS of perhaps 16-17 months for rGBM patients who only received chemoradiation.
When temodar was introduced it was hailed because it increased the mOS of nGBM patients by a few months. Due to DCVax-L, that mOS of nGBM patients has now been further extended by an additional 2.5 months.
The increased survival time of DCVax-L treated nGBM and rGBM patients is thus appreciably greater than that of patients treated only with temodar. In fact, temodar only extends the survival of nGBM but is not used for rGBM patients.
Bottom line: The introduction of temodar as a treatment for GBM patients was hailed as a stellar improvement. The results obtained with DCVax-L will speak even louder than those that were obtained with temodar.
Thank you ATL for Dr. Prins's 2014 statement and the response you obtained from chatGPT.
Furthermore, if Dr. Liau had not believed that poly ICLC could be shown to be an efficacious integral part of the vaccine, she would have indicated that in her combo trial graph by listing DCVax-L and poly ICLC as two separate treatment components. By not indicating that in the trial results (graph) and recently stating that in that combo trial, all recipients of DCVax-L also received poly ICLC, she is transmitting that henceforth poly ICLC is an integral part of DCVax-L.
By the way, it is unfortunate that at the start of the phase III trial (2007-2008), the importance of adding poly ICLC to the DCVax-L treatment was not yet established. I bet that If those patients had received both components of the vaccine, many more lives would have been extended and perhaps a few more would have been saved.
ATL, I believe that you are right to merge poly ICLC with DCVax-L because unlike for example keytruda, poly ICLC directly enhances DCVax-L's capability by acting as the DCVax-L's activation and maturation agent. In fact, theincreased immunological activity of DCVax-L is dependent on the addition of poly ICLC.
Keytruda OTOH is an adjuvant that does not directly enhance the activity of DCVax-L but rather unmasks the tumor antigens that then become a much more vulnerable target for the poly ICLC potentiated vaccine.
Thanks Smokey. I did look over some of the posters' posts but I did not get any insight from them. The 5/6 post stated that DI said that the MAA required a ton of work. That is something that I suspected but does not tell me where we are in that process and whether most of that ton of work has been completed or is still pending.
Unfortunately, it does however caution me to consider the possibility of a post June MAA submission. Of course I am hoping for an earlier submission (i.e. late May, June) but am not
counting on it.
Thanks Jackxkr for the info. Still hard to believe that DI gave an indication that it will take some time before the MAA application is submitted because there is still much work to be done before this is about to happen.
Having read on this MB many reports of conversations with DI, I don't recall when DI has ever given even a qualitative hint about the amount of work or time that is still ahead of us before we get information about a material event.
So true Senti. Add me to the retail investors whose retirement savings have been heavily impacted by those Broker manipulating creeps. I very much hope that Cohen Milstein's litigation of the NWBO law suit will duplicate the success of their Wells Fargo litigation.
Thank you Sharpie for your follow up with Benjamin Mueller. Let's hope that he will respond to your question and will show an interest in our clinical trial. I don't know how far his interest will extend but we can only hope for the best.
Today the NY times published an article entitled "PANCREATIC CANCER VACCINE USING MESSENGER RNA SHOWS PROMISE IN SMALL TRIALS" This article, authored by Benjamin Mueller has been mentioned on this board a few days ago. I bought the paper today and I was surprised to see this article taking up a fifth of page A23 (first section) because this was a very small trial with only 16 patients.
Here is a quote from the NY Times describing the methodology: " Researchers at Memorial Sloan Kettering Cancer Center in New York, led by Dr. Vinod Balachandran, extracted patients' tumors and shipped samples of them to Germany. There, scientists at BioNTech, the company that made a highly successful Covid vaccine with Pfizer, analyzed the genetic makeup of certain proteins on the surface of the cancer cells.
" Using that genetic data, BioNTech scientists then produced personalized vaccines designed to teach each patient's immune system to attack the tumors. Like BioNTech's Covid shots, the cancer vaccines relied on messenger RNA. In this case the vaccines instructed patients' cells to make some of the same proteins found on their excised tumors, potentially provoking an immune response that would come in handy against actual cancer cells."
"The study was small: Only 16 patients, all of them white, were given the vaccine, part of a treatment regime that also included chemotherapy and a drug intended to keep tumors from evading people's immune responses."
"The vaccine provoked an immune response in half of the patients treated, and those people showed no relapse of their cancer during the course of the study, a finding that outside experts described as extremely promising."
"In patients who did not appear to respond to the vaccine, the cancer tended to return around 13 months after surgery. Patients who did respond, though, showed no sign of relapse during the roughly 18 months they were tracked."
While I find the results promising, I would like to note that this trial was very small (16 patients) and I don't understand that given that in the non responders the cancer tended to return within 13 months, the positive responders were only tracked for 5 additional months.
The cost of this treatment will probably be reasonable and with some effort was already brought down to about $100,000 per patient.
For me it is rather disheartening to see that such a small study gets this substantial publicity in one of the major USA newspapers while our much larger and very successful phase III study has never been covered and publicized in the major USA press. Perhaps we will have to wait for MHRA approval before LP makes the decision to end NWBO's under the radar policy
[/quote]I respect the fact you don't want to spread rumors, so on another note, what timeframe do YOU expect for things(MAA, Approval, partner) to hit? quote
Attilah, a very well stated question. For many of us, after such a long wait, it would be very different for good news that is beyond our expectations to materialize within two months or two years.
Thanks Jfr, that's what I thought.
Jfr1611, Don't you mean that 45 days after the acceptance of the MAA by MHRA, the MAA will be granted?
Attila, if we are experiencing now a full court press to meet the Monday deadline, why was there no SP increase already yesterday or even late last week? It looks more like someone very recently got hold of some valid or wrong information that may be related to the submission (MAA?).
Likely we will know much more within the next two weeks.