Single Stock,

I believe you are mostly correct but perhaps a few more fines because of a little less time to locate after settlement date will start to shire things up a bit albeit not that much with this action alone. Successful lawsuits, on the other hand, will help create the real change needed. Best wishes.

Nemesis18,

Finally a witty post from you… or your lawyer ; ).Best wishes.

flipper44,

I think we have different ideas about what an offer she couldn’t refuse would look like is all and that is to be expected at this point. This kind of difference, though, is the kind of thing that stokes those seeking divided interests amongst retail for their own purposes. Some are looking very short term, others 3-5 years and still others may be thinking longer than that. Targets will be all over the place because of this and speculation about the best path forward for development with them. When we get more info about the chosen path and realistic growth targets given the price will begin to reflect that. Best wishes.

flipper44,

The issue is that one will not offer what the sum of the parts is worth. Hence, no offer from a single source will be good enough with regard to actual value of the platform. Both Linda and big pharma know this. Big pharma and friends are hoping retail can’t figure this out. This is why some have said, myself included, that no one pharma would be able to buy NWBO outright. Best wishes.

Romans516,

Great post and I wonder how many from congress had checks cashed that came from hedge funds and market makers too?; (. Oh and where does the media get big advertising money from?: (. Best wishes.

Nemesis18,

Thanks for the heads up about the next Phase Five report and its potential coauthors; ) . Best wishes

iclight,

Calling Drs Linda Liau and Keyoumars Ashkan shady and their work a scam is a pretty bold statement that is clearly countered by the peer review of Phase 3 L trial results in JAMA Oncology. This coming from an anonymous poster who can find no good in what these doctors have done for their patients with Dr Linda Liau’s vaccine and NWBO’s ability to move it into a commercial scale production model. Hmmm.. something’s wrong with this picture, maybe you stepping to the side lines for the next pic will clear things up ; ). Best wishes.

hyperopia,

Thank you for this well thought out take on things NWBO. I agree completely that hedge funds are involved but I also believe it goes well beyond hedge funds because the SEC and DOJ have been alerted for a very long time. They would have acted much more quickly if strings were not being pulled to prevent a much bigger cat out of the bag in my opinion.
Those within government are alerted to threats that are both military, political and economic in nature. NWBO poses both an economic and political threat to those who have created the status quo structure that they are about to break out of. If this were not the case, SEC and DOJ would have been able to act much sooner in my opinion. I believe they are waiting out the approval process for the reasons you mentioned mainly but also gathering info and connections of those trying to prevent this from happening at the same time. This is also likely happening while some within SEC and DOJ may be working against this process or informing those being looked at what is happening ahead of time. Big organizations are just typically more susceptible to influence peddling so this can’t be ruled out.
All in all, NWBO is doing what they need to do to make a big difference in many ways. Those who understand this are their staunchest supporters. Best wishes.

dstock07734,

FDA has made some changes over time and they are well aware by now of the impact about to be created by DCVax. Influence only goes so far before a breakthrough makes its way to the forefront and anything trying to hold it back becomes mostly futile. Back in the day the influence on FDA was considered insurmountable which is why so many biotechs found themselves caving into “the process”. Best wishes.

Poor Man -,

One obvious reason NWBO might have chosen to submit first with MHRA is that a cash strapped company needed to wait out guidance changes at FDA where big pharma has considerable influence. They might have also considered the promising innovative medicine (PIM) and National Priority designations as a sign that MHRA was ready to act favorably without the heavy influence of big pharma getting in the way. No designations like that in the states anywhere to be seen.
Linda understands leverage and big pharma has it with FDA, media and politicians. Consider that no politicians are openly talking about DCVax in the US and yet in the UK there are discussions about the need for brain tumor research, trials and other which leads to mentions of DCVax in those circles. The media has been almost dead silent about advances with DCVax development while Cambridge outlets and others have been talking about NWBO and Advent. MHRA is likely more influenced by high ranking clinicians like Dr Keyoumars Ashkan and advocacy groups than by big pharma. All in all there is a more favorable climate in the UK than in the USA. Linda will always start where she has a better chance to gain traction and a few years back she and others were able to be present with government officials at a health care meeting that I think Lykiri shared pictures of. I have never seen anything like that happen in the USA. Best wishes.

Idunno,

Sure seems like that opinion is part of a job whether paid for directly or not; ). Best wishes.

learningcurve2020,

Sure and SEC and DOJ could have just let Ken and others spoof illegally for years without doing anything to stop them while booyah mocked and scoffed. Oh wait… that is actually what happened. Guess maybe your idea isn’t so good after all; ). Best wishes.

sentiment_stocks,

Yes, that little piece of information is key to understanding that the “fitting out” of at least one operational clean room is likely being described. This model then can be replicated site wide and “franchise” wide based on an approved model. Since at least one clean room likely is or will be being fitted out with GMP grade units and the “site” has already been GMP certified, any final inspection, barring any unforeseen additions or subtractions, will likely be able to pass all GMP commercial scale final inspections. Within this scenario is the outside chance that multiple clean rooms are being approved at the same time as a site buildout.
I have long expected that at least one clean room would be Flaskworks fitted out to compare against artisan during the approval process and that still may be in play. If anyone has any question at all about why this has taken SO long since last patient enrollment, one word… manufacturing, manufacturing, manufacturing. Your mention of price concerns, which point to NICE input, have also certainly been part of the equation in subterfuge. Patient demand being matched with product availability is indeed cost related as most patients simply will not have the funds needed to pay for treatment themselves but the funds must come from a pool. Endless funding is not available except at the FED and IMF and even they are controlled by the puppeteers. Best wishes.

georgebailey,

Just the patent for optimized DCs flipper44 has been posting about for a while but as you can imagine with what has been learned since the Phase 1 trial, optimized Direct is a blockbuster that will likely need zero help proving itself in very short order once put to the test. Everybody and their brother will want this treatment and I am nearly 100% certain that after the L Phase 3 validation, there will be no SOC/placebo comparator in any forthcoming Direct trial.
Imagine immune responses possibly being seen in 100% of trialed patients by about 8 weeks or less. Imagine completely necrotic or undetectable secondary tumors by about 12 weeks. Imagine immune memory cell populations increasing and possibly being used in animal models with bio similar tumor type challenge to demonstrate protection against reoccurrence. Let’s see what happens; ). Best wishes.

hyperopia,

The threat to temodar by L and then Direct is real but so is the threat to potentially all other chemo treatments that have nasty side effects. Chemo/rad in oncology is a $2,000,000,000,000 market cap enterprise. How quickly can that wealth transfer happen without a major economic disruption?; ). DCVax-L had to be developed first for safety for use in GBM/rGBM but also, in my opinion, because of coming economic impact from the platform. Best wishes.

georgebailey,

It gets better. Not only is autologous accounted for but matching donors are listed in the patents as well as knowledge of who responders will be prior to treatment based upon creating required post activation/maturation DC characteristics needed to overcome cancer defenses. This not only identifies but also maximizes the number of patients qualifying to receive treatment. Having manufacturing and product release obstacles overcome prior to advancement of Direct creates the time for ramp up runway needed when approval(s) come.
One last economic balance consideration is that L basically invites others to join in search of best combos and “franchise” experience while Direct likely eliminates much of that need as a much bigger disruptor. Best wishes.

newman2021,

You must admit that today, at least, the longs are being thoroughly entertained by their posts while we wait; ). Best wishes.

sentiment_stocks,

“Because, given that NWBO would PR the opening of an office door, I can guarantee that it wasn’t good news, in relation to the MAA application.”- Nemesis

How exactly would you “guarantee” this?- sentiment_stocks

Easy, with a disclaimer that it is only personal opinion in the micro fine print or constitutionally protected free speech😊. Best wishes.

learningcurve2020,

Autolomous!; ). Best wishes.

learningcurve2020,

The answer to that is digitized oversight which was not mentioned. Minimal opportunity for errors and greatly speeds up product release which is still more of an issue with artisan. Best wishes.

iclight,

No, not at all. Your lack of understanding the exceptions to adequate and well controlled studies and regulator influence on trial design that was actually beneficial to the patients is your problem not that of the longs, regulators or the patients. Longs are the ones who understand this and that dilution until approval and proof of expected revenue stream that points to profitability by a certain time frame is what keeps the price down with plenty of help from manipulators along the way.
Traders want to see swings in the mean time to make more money while longs keep absorbing the dilution without the help of excited new investors hoping for a quick return on investment. This makes movement of share price relatively easy with small moves one way or the other. When news hits those who were short will go long and work the swings on the way up and back down after being over bought which won’t really happen until institutions get their fill. We are just in the doldrums of retail accumulation and company sales of shares to keep the lights on until news. Unlike what you profess I am looking for the big gap up day that will never be filled because the science and methodology will win the day. It will also likely be utilized as an example in future guidance about how to navigate and overcome some tricky patient welfare considerations during trial setup that might lead to a change in adjudication methods of treatment effect before unblinding. Best wishes.

Inquirig,

No other study had an active treatment causing treatment induced pseudoprogression in a significant group of patients. It’s what is obviously being ignored that is important and that is why the negative Nellie’s are leading newbies away from it by steering conversations away from the obvious reason for the discrepancy. Try again!; ). Best wishes.

exwannabe,

Exceptions to adequate and well controlled studies allows for changes, when done prior to unblinding, when measures utilized to distinguish treatment effect from comparator, in this case SOC/placebo, turn out to be unreliable. The fact that regulators had a say in trial design, which included crossover to a potentially active treatment, created a situation that all parties had to make adjustments for when treatment effect, as noted by pseudoprogression, made these changes an absolute necessity. This necessity became even more apparent when the Germans no longer allowed their patients to join in the SIC/placebo arm. This arm was likely determined to be a lessor treatment (Fraunhofer’s claim that enrollment occurred only to the point statistically necessary) especially for low absolute lymphocyte patients which were only allowed into the trial from that country and typically would progress more quickly. The fact that not all of them did progress quickly was noted in the interim blinded data presented as being part of the longer lived patients. Early treatment advantage for low ALC patients had to have been clear very early when typical progression happens at about 7 months and treatment induced pseudoprogression can be noted by 8 weeks. Kind of a big deal that no one is talking much about but clearly was a distinct possibility and likely a high probability because it would explain all other actions taken quite well, including Les trying to cover up the enrollment discrepancy for the sake of data maturation and blind. Try again!; ). Best wishes.

Inquirig,

Too funny as these comments refuse to take into account that SOC crossover led to being on an active comparator. This was good for the patients, right from the regulator point of view to do what is best for the patients but made distinguishing benefit from early treatment vs later treatment impossible to compare within the original trial parameters insisted upon by regulators. This and the regulators forcing SOC/placebo to be under enrolled was an interference that they could be held accountable for if a pathway to approval was not created.
Besides this, the exceptions to adequate and well controlled studies allows for changes in methods used to determine true treatment effect when existing ones turn out to be inadequate to measure it. Hence the SAP was put in place before unblinding and comparators created by an independent group of researchers to greatly reduce the chance for unwanted bias. It is their reputations that are on the line for creating and using the data they did for the ECA comparators.
Trying to link NWBO to these comparators is a deliberate lie perpetrated by those whose “opinions” include pointing to NWBO being responsible for their composition which is blatant lie that you said if anyone could point out that you would admit to. Shall I go on?; ). Best wishes .

Single Stock,

You seem to be implying that Michonne has come out of retirement ; ). Best wishes.

flipper44,

I believe the testing that NWBO referred to is for both artisan and Flaskworks versions. I believe that your time line of June is probably close for final fitting out and testing. I also believe that time line is critical to when initial approval is given for artisan while Flaskworks may take a little while longer for final validation. That the timing for both versions to be validated seems to be lining up fairly closely seems abundantly clear to me even if “approval” does not technically require completed formalized Flaskworks validation prior to initial approval, only adequate proof that it will be. Best wishes.

meirluc,

Theoretically a partnership could come at any time if that is the route chosen. The value of Flaskworks along with approval increases the bargaining leverage considerably and if there is anything going on in India that bumps leverage up even more. Maybe no one can do anything that looks sane in regard to a partnership with NWBO until the market wakes up to what NWBO has done and no big pharma seems to be in any hurry to do that for obvious financial reasons considering what the truth about the relative importance of the DCVax platform implies; ). Best wishes.

biosectinvestor,

I agree about prioritization but the article I read suggested demand would outstrip current rate of facility growth for a while. Probably not for GBM but this is a platform treatment that is going to be in great demand off label too as well as others bringing their cell therapies into trials and to market. The article was about the big picture and is just something to keep an eye on because expected change is coming and for many it will be much sooner than they expect. Best wishes.

DJPele,

This is why I believe that much of the post COVID delay is related to getting Flaskworks manufacturing in place. Not because it is directly part of the application but that it is so important for expected demand created and pricing, that it must be sufficiently advanced to the point where ramp up demand can be met by availability once artisan is approved. I believe NICE wants to be ready for this too and is quietly but actively preparing for what they expect to happen. Best wishes.

DJPele,

FDA does not require the final method of manufacturing chosen to be fully approved and validated before submission but it needs to be completely in place I believe one month before an application decision if that is the process chosen for the approval. In other words, MHRA could be considering artisan primarily with Edens being looked at separately but along side while FDA could be looking at the same but with Edens part of the application if it is expected to be ready by the time of their need of it for a final decision based on it. Best wishes.

sharpie510,

Just goes to show how complicated the insurance decisions are in the US based on likelihood of any given scenario. Every situation is different as explained in this case where the patient had no previous chronic need for expensive drugs like many do prior to her cancer diagnosis. These folks were blessed to hit the correct plans for their situation. Many are not so blessed and nothing was stated about how plan D for drug coverage was handled and the added cost of that when considering supplement coverage. Risk management for any given individual is very difficult with so many unknown factors. This is why reducing actual cost related risk through negative and positive reinforcements over a lifetime of health related individual decisions should be a top priority for all community health related coverages. Best wishes.

flipper44,

Actually the prisoner camp game was changed to 3 bullets in the chamber and no more spinning. Mike watched and saw that the bullets were loaded in consecutive chambers. Once the first two chambers were empty the odds favored the shooter to be able to go on the offensive by surprise with 3 out of 4 chambers with live rounds. Getting buy in from the friend to take the second trigger pull was the hard part mentally/ emotionally and was key to what happened in the rest of the movie.
In the prisoner scene everyone was laughing after the second trigger pull, the guards because they expected the next trigger pull to be fatal to a prisoner and the prisoner Mike expecting the next pull to be fatal for a guard. This happened while Mike was laughing, getting the guards laughing then got serious to focus on what he was about to do then started laughing again to get the guards relaxed and off guard right before he took the gun off his temple to shoot the armed laughing guards who did not recognize that the tables had turned. He then shot a second one and a third one knowing two pulls might possibly be needed with the first kill attempt but that two more live rounds would follow the first discharge. In the mean time the other prisoner, understanding the situation, got a guard’s gun who had been killed and started shooting as well.
Survival happens when you keep your mind in the game to find ways to improve your odds when others are loosing their own minds or are taken prisoner by fear. See any connection to FUD and investing in biotechs? May 10, 2022 maybe?; ). Best wishes.

skitahoe,

Praying for a speedy recovery and happy for you that the leg pain is no more; ). Blessings and best wishes.

iclight,

Oh we would trust that you have 20,000,000 shares at $.17 but for the fact that pretty much everything else you have ever posted on this board is clearly antithetical to that claim so no dice; ). What’s the teaching about a good name being better than riches?; ). Best wishes.

iclight,

Wrong! Truly unbiased opinions are always welcome but when someone dismisses things pretty much out of hand or comments without detailing the entire picture because of likely conflicts of interest then that’s a problem. Many folks here have more “skin in the game” through personal connections to GBM patients and have been looking for a cure than those who constantly bash so we are likely to call out those who do not present the entirety of the picture. The interview at Brown University with the folks looking at the data clearly gave pluses and minuses in their comments about the data. They were objective and still consider DCVax-L a breakthrough because the data is still very compelling in spite of the known limitations created by trial design with crossover which ended up being best for the patients even if not best for the interpretation of trial results in absolutist terms. The problem with absolutists is they give no reasonable consideration for what might be best for patients but believe it or not, most times regulators do; ). Best wishes.

Sojourner55,

Good Friday for personal reflection, giving thanks and reestablishing priorities. Thanks for checking back in and look forward to your return at the appropriate time. Blessings and best wishes.

mike00h,

Thanks for the great break down. Just remember that because NWBO announced that they expect a RFI clock off period they do not need to announce one if it happens. Approval could happen any time between now and September if there are any delays to meeting expected timelines. Just be ready for any eventuality because manipulation is present and always working on investor sentiment for their advantage. Best wishes.

flipper44,

Sure seems to be going side by side all the way towards approval. The plan was that artisan gets there first but Flaskworks can’t be far behind either because NWBO, the regulators and NICE know what kind of demand will come afterwards. Do you really believe it takes artisan 4-6 months to become GMP level testing compliant AFTER their already approved MIA cert at the facility?; ). Best wishes.

flipper44,

I did look at those charts. I just did not come to the same conclusions as others about breakout because the expectations are off in my opinion. I believe the bears wanted to run this up to have something to work with to press back down this is why I said we need to wait until at least Tuesday. I believe they think they have part of the summer to work with yet to create another swoon. They want a sell in May and go away scenario to get traders and worn out longs to sell them cheap shares right before their expectations for news. If manufacturing testing is going to go on through the second quarter then they likely hope to get the full swoon in before mid July.
This was probably just market makers and bears taking advantage of anyone hoping for good news now and a retracement of sector buying after the NVCR news got looked at more closely. The new board member has not been announced to be a White Knight either as some had hoped. Best wishes.

dennisdave,

Nope!; ). Approval brings attention and interest that can be responded to. Approval allows patients to access set aside funds in the UK immediately. Approval allows Linda to talk about a PLATFORM treatment that initially can be considered for study and off label use in all solid tumor tumors. Approval gets investors talking about partnerships and implications regarding impact on valuations of competitors and potential partners including on companies that they are invested in already. Approval brings steadily rising interest and share price as new investors go through their own learning curves and market makers will no longer be able to control the flow of information by controlling the price as much as they have in the past. Best wishes.