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Gary, I believe that whether the street does or does not understand the excellent results inherent in Dr. Bosch's presentation is not relevant because most of the investments in this stock are carried out by long term shareholders who understand the value of this stock and maybe there also has been a participation of newvbies and traders. The majority of those types of investors are quite bullish.
The trouble emanates from the many shorts, hedge fund participants, and BP affiliates who have been receiving support in trying to destroy the company because they very well know that NWBO's success will result in failure of their interests; they of course also know that this new treatment represents a huge breakthrough. I am fairly certain that even AF understands that DCVax-L represents a huge breakthrough in cancer treatment.
I am therefore afraid that once MAA is submitted, accepted and even approved, the attack on the SP will continue at least until approval of DCVax-L by the MHRA.
I am afraid that we may have to prepare ourselves for an additional extension of our already long campaign.
If we don't have MAA submission yet but will have it sometimes in the near future, I fear that between MAA submission/acceptance and MHRA approval, enough time will elapse for the wolfpack to continue to decimate the SP.
Any thoughts about this possibility.
Yes Perk, that is what this long wait has done to me and probably to many others.
Couldn't help it Reefrad but while your wishes to Skitahoe seem reassuring, I have lately been attacked more by pessimism and have been occasionally feeling that even a higher power will not help us shareholders (afilu hashem lo ya'azor lanu).
Very much hoping that I am wrong.
Thank you Reefrad for your very comprehensive review of the conversation you had with DI. It gave me the impression that as always, the company is moving slowly but very meticulously to their next goal which now happens to be the submission of an errorless MAA to the MHRA. The only question is how "soon" we can expect that to happen and by now, many of us on this MB have a very different interpretation of that word.
Edit post 608098 should read "a walk on the sun".
Well flipper, while milestones like a walk in the sun or sticking a Cadillac up one's nose seem like a bridge too far, making peace in the Middle East would be very difficult but eventually possible but it would be really nice if No 10 would be: PROOF OF QUALITATIVE EQUIVALENCE BETWEEN THE MANUAL AND FLASKWORKS/EDEN DCVAC-L PRODUCTION.
Or maybe that too is still for now a bridge too far that is scheduled for a much later crossing?
Any suggestions?
Foogie, I sincerely hope that your friend can get the very crucial help that Dr. Ashkan can offer.
I was also impressed that over the past years, many of Dr. Ashkan's patients who received DCVax-L, were Americans. I am also wondering whether since March 20 (after reception of the MIA), more patients from the UK, USA and Europe have been taking advantage of Dr. Ashkan's services.
We may get more information about those self pay services about a month from now, in the next 10Q.
MAA submission by the end of August? That would be nice but can you share the clue(s) that led you to your prediction?
With all due respect Zadie, the reasons for the SP tumble on 5/10/22 were not just a reaction to NWBO's failure to update the GOV website and that is indicated by the following:
1. The precipitous fall of the SP during Dr. Mulholland's introductory remarks and before the presentation of any of the sensational results.
2. The fact that there was an absence of any meaningful SP recovery even after the appearance of the revised website.
I am not saying that NWBO's failure to update the website in a timely manner was not a mistake but am of the opinion that the attack on the SP would have been as forceful even if NWBO had avoided that error. or if DR. Liau had been in charge of the NYAS presentation.
OTOH by orchestrating the 5/10/22 debacle, AF et. allies may have put themselves in a deep hole because the 5/10/22 attack on NWBO greatly strengthened the suit that AF's allies have to defend against while facing a very strong adversary (Cohen-Milstein). Ironically, it is therefore actually possible that the mistake committed by NWBO may have elicited an even bigger mistake by the opposition which in the long run may turn out to be a big plus for NWBO and a big minus for their opposition.
Finally, the brisk hiring activities by Sawston does not translate into a mere dilution of NWBO's resources. It most likely indicates that Sawston is ready or is getting ready to expand its capabilities of treating an ever increasing number of compassionate care patients and after MHRA approval, many more reimbursed patients.
Get a grip. You can do better than this.
Maverick, NWBO is hiding something that they are hoping will not emerge until sometimes next year? Are you perhaps guessing that they will not submit the MAA application until they have substantiated the efficacy of the Flaskworks/Eden manufacturing methodology and will skip any prior utilization of the well established manual manufacturing methodology?
The next 10-Q may or may not surprise us with regard to the funds that a larger number of specials may have earned for the company during Q2.
1. Has any data been released to date as to whether a higher proportion of patients with the methylated GBM than those with the unmethylated GBM have opted to pay the high cost of the DCVax-L treatment because it has been known for some time that the methylated GBM patients benefit much more from the DCVax-L treatment than the unmethylqted GBM patients? Furthermore, utilizing the methylated GBM patients for a comparison of the two manufacturing methods would allow us to obtain much more accurate results as to the comparative efficacy of both methods.
2. Is it possible that some of the specials patients (especially those with the methylated GBM) were treated with the automated vaccine manufacturing method (Flaskworks/Eden) for the purpose of testing this methodology against the manually manufactured method and were not asked to pay for the treatment because it would be unethical to charge them for a manufacturing procedure whose efficacy has still not been tested?
Note: If a substantial number of "specials" patients have gotten this free ride, the amount of money earned from this "compassionate program" reported in the next 10-Q may not reflect the larger total number of patients that were treated during Q2.
Reefrad, I appreciate that you made an effort to speak to DI but I am disappointed because it does not bode well for us when you state that things are moving forward slowly and it does not help to be reminded that a number of milestones were already achieved because frankly, those successes were also achieved over a humongous period of time.
I gather from your conversation that DI believes that either submission or acceptance of the MAA application is in the material events category and should be PRd but if so, given that things are still moving forward slowly, NWBO style, we may be forced to relax and enjoy most or all of the summer before that PR of the MAA's acceptance hits the airwaves.
That said, I am still bullish and really hope that I am wrong
The 99 were randomized to "an intent to crossover group" of whom 64 crossed over, 29 did not and 6 dropped out of the trial. The 92 remaining in the "intend to crossover group" had an mOS that far exceeded the placebo groups and even exceeded the mOS of the DCVax-L trial's treatment group.
Dr. Liau implied in one of her presentations during the Q+A period that the 29 permanent placebos had an mOS that was most likely lower than that of the placebos. It is easy to deduce that the remaining 64 crossovers in the group of 99 had an extremely long mOS.
Conclusion: DCVax-L treatment after progression is very efficaceous and greatly increases the mOS.
Excellent point RRH. Due to the fact that payments for the specials are received over time and the payment allocation between NWBO and Advent as well as the allocation time is for us an unknown, we will not know for a long time if ever, how many specials have been treated so far (including during Q1 and Q2 , 2023) and how many will be treated before the NICE reimbursements kick in. At this point I am guessing that the number of patients treated under the compassionate program (Specials) in Q1 is already much greater than we previously thought because the money paid by those patients only represents a partial payment for their treatments.
Of course once approval from MHRA is received, the company can inform us as to how many specials had been treated in the past and later, how many insured patients are being treated each quarter.
I believe that once MHRA approval is received, the company could be much more transparent with respect to the number of patients treated over a specific period of time.
With regards to specials revenue, there is no reason that if Q2 fetches only max 2M $, Q3 cannot fetch double that amount. Who says that revenues have to remain the same for every Q?
Another reason that comes to mind for dropping temodar from nGBM patients treated with DCVax-L is that while temodar apparently reduces the regrowth of the remaining tumor, that further diminishment of the tumor after surgery may not be that important once DCVax-L is administered because the results of the phase 3 study have shown that DCVAx-L treated nGBM patients who have undergone suboptimal tumor resections, stood out in having a much better survival record than nGBM patients who have also undergone suboptimal tumor resections but only received temodar.
Chiugray, as far as I know, temodar has not been used for rGBM patients because it is useless for those patients for whom no established SOC exists. Consequently there is no reason why DCVax-L in combination with poly ICLC and without temodar would not be approved for rGBM patients.
The situation is quite different for nGBM patients because temodar has been shown to have efficacy for methylated nGBM patients though much less efficacy for unmethylated nGBM patients. The problem is that temodar can temporarily dampen the ability of those nGBM patients to mount an immune response and hence may interfere with DCVax-L's efficacy. I am therefore guessing that methylated nGBM patients receiving DCVax-L should not be treated with temodar because it interferes with their immune response and unmethylated nGBM patients treated with DCVax-L should also not be treated with temodar because it is not very effective in those patients and most probably also interferes with the limited benefits they receive from DCVax-L.
Unfortunately, my opinions don't translate into approval to delete temodar from nGBM patients and that decision may require a number of small trials.
We should know how much the compassionate $s brought in around August 10 from the next quarterly.
Ex, we don't know what happens behind the scenes. Perhaps the physicians and their patients in the specials program are given the updated information about the apparent improved efficacy of the combo vaccine and the fact that it is used at UCLA and are then given the option to include or not include poly ICLC in the treatment. To date, as far as I know, there is no evidence that adding poly ICLC to DCVax-L is less safe than administrating the vaccine alone.
If you were the GBM patient, would you opt to be treated by DCVax-L alone, the combo vaccine, or neither?
I know what I would do.
You are right Ex but than why not ask both questions at the same time?
ATL, I believe that it would be criminal if the UK GBM patients treated via the compassionate program are only receiving DCVax-L but no poly ICLC. Given that the UCLA patients are treated with both DCVax-L and polyICLC, deleting poly ICLC from the treatment in the UK would make no sense at all.
Thank you Branster for your initiative. In July you may get the response that the company had not as yet submitted an MAA application to the MHRA which would be disappointing or you may get a more encouraging answer that the company requested the MHRA not to release any information as to any application it had submitted. Both of those MHRA responses will most likely give us some clues and at least a partial answer is better than zero information.
Thank you Stonkmaster. If Dr. Liau's presentation has been removed and not yet replaced, I am back to square one in trying to tie breadcrumbs to NWBO's expected milestone events. I am curious to find out whether or not we will get for that slot another speaker who will discuss the progress of the DCVax-L trial or whether another topic will be presented.
Ex, I believe that LL is planning to present at the CNS conference but may not do so if NWBO has not reached an important milestone.
It is of course possible that the title is only a placeholder but my suspicion is that it is not, because by September 9, more than five months after being granted the MIA, enough time has passed for the MHRA approval to become a reality. Furthermore, I do not recall that LL ever used that presentation title (Northwest Biotherapeutics) for a talk that was later canceled. We have about 2.5 months left to 9/9/23 and by now, LL should know what the topic of her presentation will be and whether it is likely that she will be able to present on that date.
My guess is that if NWBO does not reach an important milestone by 9/9/23, LL will cancel her presentation.
Springbok, I am not the only one who has been confused because when it comes to many other confused posters on this board, I have been in good company.
After recently posting on this subject and reading yours and other posts, I am somewhat less confused. Most likely, the company will only release a PR, when a milestone is actually achieved. For example, leaving a 45-90 day gap between a submission and approval, while annoying for longs, is a gift to the shorts and that would not be in NWBO's interest. So when it comes to questions about the timing of submissions, acceptance and approvals, there is no reason to engage DI.
OTOH we may pay attention to other hints.
1. We may find out from the next Q that between April and June, more than 100-150 compassionate DCVax-L patients (specials) were treated (courtesy of the comedian LG).
2. Most likely that LL's title for her 9/9/23 presentation "Northwest Biotherapeutics" is not just a placeholder title but can become one if no NWBO milestone is achieved by that date and another presentation is substituted. Alternatively, the entire presentation can be cancelled (anything is possible).
In summary, perhaps NWBO is following the path of maximum flexibility and will only pull the information trigger when the facts (milestones) are in the bag.
FeMike, I believe that Dr. Liau's title for her 9/9/23 presentation (Northwest Biotherapeutics) is not a placeholder because I don't believe that by this time, she still has not chosen the topic that she believes will be ready for presentation. Of course if by 9/9/23, NWBO has not reached a significant event (MAA approval?) and LL has some exciting new scientific data that she can present, she can change the title of the presentation and present that exciting data. Alternatively if NWBO has not reached a significant game changing event and LL has no new data to present, she can simply cancel her appearance.
All that will be clarified within no more than 2.5 months.
Dr. Linda Liau's September 9 presentation still represents an enigma for me because the title of her talk is our commercial company (Northwestern Biotherapeutics) and not the vaccine that Dr. Liau developed nor the scientific steps that are increasing the efficacy of the vaccine, etc. It is hard for me to believe that Dr. Liau would plan a talk about NWBO on September 9, if she believed that by that time NWBO has not yet achieved one of its major objectives (MHRA approval?). Without a milestone achievement by the company that involves Dr. Liau's creation, what would be left for her to talk about? I would welcome any alternative explanation for why Dr. Liau chose that title for her presentation.
Perhaps instead of of asking the sphinx to decipher DI's statements, we should make more of an effort to come up with the possible directions that the title of the 9/9/23 presentation may be pointing to.
Exactly JTORENCE. Apparently some IR reps are paid well for informing and others for disinforming.
Thank you survivor for the additional DI based information which unfortunately leaves me (and probably others) with even more questions than answers. Fortunately, DI is not only keeping us longs guessing but he is also confusing the opposition.
If Citadel , Virtu etc. are planning to BK their subsidiaries and shovel the money into offshore accounts, NWBO+Cohen-Milstein may lose out financially but NWBO will most likely gain a tremendous amount of positive publicity as the company whose spectacular cancer treatment has forced the hand of those Wall Street criminals. It could also be a forced wakeup call for the SEC and Wall Street insiders who would be exposed for having colluded with or ignored those criminal activities for many years.
Survivor, regarding the MAA application vs. approval, DI's statement that we have to look at "how we have handled these milestones in the past" suggests that:
1. Like the MIA approval, the arrival of the MAA can be referred to at this year's ASM as arriving at the not too distant future.
2. Or the MAA's submission can be PR'd at any other time.
3. Finally, what or what not to PR, ultimately depends on what is best to get to the goal of product approval. This last DI alternative leaves many paths to announcing MAA approval wide open.
In summary, deciphering the Rosetta Stone was probably easier than deciphering DI's answers. The silver lining is that while he keeps us longs in total darkness, the opposition is experiencing the same fate.
Foogie88, besides the potential of the Sawston facility as a CDMO that will earn a lot for NWBO, there is also the huge potential of NWBO's reception of funds via its lawsuit against the 7 spoofing companies. Gains from that lawsuit may greatly exceed the earnings ftom the Sawston CDMO, so that is something to keep in mind.
Concerning DR. Liau's presentation at the CNS symposium on 9/9/23: Any guesses as to what she will be able to say within 10 minutes about her topic (Northwest Biotherapeutics) that we don't know right now but will be first presented by her within less than 3 months from now.
It is hard for me to believe that Dr. Liau will simply rehash information about NWBO that we already know but will perhaps be new to that audience. I believe that up to now the subjects of Dr. Liau's presentations were strictly about the science and never about any company that utilizes the science to make a commercial product. However, I am hoping that this time we will receive much information about a company has utilized breakthrough scientific knowledge to produce a documented, game changing cancer vaccine that has just been approved by at least one regulator.