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mike00h,
Lots of things can be added to L to make it more potent and this demonstrates one more approach that might be worth exploring. Best wishes.
iclight,
That would be like someone asking you why you are not an NWBO basher. L does work so no need to ask why it doesn’t anymore than anyone needs to ask why you are not an NWBO basher. You are.
Now if you want to know about how L can work better then you might want to read up on Poly ICLC, CSF-R1, checkpoint inhibitor pembro used in combination with L and RevImmune’s IL 7 product for boosting T-cell performance; ). Best wishes.
Nemesis18,
Your job is to downplay while others have the job of outright dismissal. Your attempt to downplay falls way short since the screening halt that left 17 SOC/placebo patients out of this trial basically can be viewed as a conditional green light for approval. Regulator interference can only be interpreted two basic ways. There was either a safety issue.. not, or it was proven to be beneficial ie enrolled only to the point statistically necessary (Fraunhofer). Being beneficial does not make it automatically approvable because as we all know, manufacturing must be able to meet commercial scale demand and that part of the equation is still being formally validated with GMP Flaskworks units and facilities being built out. So considering all this being either in place with manual or being fitted out with Flaskworks your “speculation” is a bit warped unless you are starting off your speculation as 5% in March of 2024 and building up the percentage by 10-20% each month from there; ). Best wishes.
Smitty5150,
In my opinion he is spouting intentional, misdirectional, negative nonsense aka lies ; ). Then again should we expect anything less?; ). Best wishes.
learningcurve2020,
I have heard “Buy when others are selling and sell when others are buying”. By the way, were Amazon or Fed Ex ever messy? Bookstores and Vegas as I recall; ). Believers were well rewarded. Best wishes.
manibiotech,
Those perps are held off to some extent by not being able to trade openly on that information otherwise there would have been an attempt at huge accumulation. As it stands everyone associated with them are still in hiding. Best wishes.
laser777,
There are those who know that the markets are rigged, know they can’t do anything on their own to change it and have adjusted their investment strategy knowing that this is what is happening. There are opportunities to play along with their trades or set up speed bumps near tops or bottoms when a cycle is in play. The unsuspecting and naive can get caught in the traps being set because they are assuming that regulatory agencies are willing and able to protect them from this ongoing manipulation which they claim is just part of necessary market dynamics irregardless of defined illegality of some moves made within their actions. Such is the state of the market… for now. NWBO and others are working to change this. Best wishes.
Inquirig,
Your “?!!!!” says it all. The question mark makes it a non declarative sentence so you are admitting to either not knowing your statement to be true or you know it’s not true and are protecting this statement as an opinion under the assumption of not knowing. Nice try but not good enough. Best wishes.
manibiotech,
Trial integrity was only one part of what I said. I believe that bad actors, apart from Mr. Neil Woodford, also came into non public information. I have no problem believing that folks with non disclosed information might have been approached by those with an agenda. Why do you think the company was attacked so heavily in 2015 when the attackers apparently went into plan B?
Mr. Woodford appeared to be somewhat acting separately at first with his own plans and not in concert with the hedge funds and market makers targeting NWBO. Hints of this came when Steven Giardino said he lost money on the 2015 April? options when Mr. Woodford had just purchased shares at a premium and share price was soaring. By October the rift was very obvious between Mr. Woodford and NWBO and cemented by different picks for the BOD by January 2016. The threats by Mr. Woodford to do his own investigation never materialized and instead he found himself relieved/dismissed from fiduciary duties at his funds.
I suspect that Mr. Woodford himself and his funds became a target and were pretty easily taken down because of the high risk ventures he was involved with that also had extremely low liquidity in some cases. Bottom line is that his dismissal led to the sell off of NWBO shares in his holdings that led to shares being sold as low as $.14 in 2017 because of the sizable holdings his funds had accumulated.
The lesson for all the bad actors is that when you mess with Linda Powers you are very likely to go down in flames. It may take a while and investors not understanding what has been going on and planning accordingly have been hurt during the process but in the long run investors expect to be richly rewarded while the perps will do their walk of shame for all to see. Best wishes.
attilathehunt,
There is a point in the development process where formal validation must still occur but is really mostly just a formality where an entire fitting out is done inspected and approved for commercial use. The original product is basically green lighted much earlier. We have the green light based on the actions NWBO is taking but the fitting out still takes a while as explained in the PR about components of the clean rooms having long lead times. Afterwards comes final inspection. In the mean time, the B grade clean rooms can be used for initial commercialization purposes which is what the MIA was based on and likely where comparability/equivalence tests were performed. Best wishes.
learningcurve2020,
The summary was in the first sentence and you saw that. The rational took the rest. Your response explains quite a bit; ). Best wishes.
learningcurve2020,
The screening hold silence was likely about trial integrity and keeping some folks with their own ideas at bay with non disclosed information in my opinion, not a self inflicted wound. I believe long term data could have been affected by disclosing the reason for the hold as patients would have wanted to immediately cross over from SOC/placebo and no finalized plan for the SAP had been created or accepted by regulators. Then there is the explanation about need to develop manufacturing over an indeterminate amount of time would have led to investors pulling out not increased buying from investor satisfaction with the disclosure. You know this but refuse to acknowledge this because it is not fit for purpose with regard to your overall stance with regard to NWBO management.
Dilution would have been significantly greater with these disclosures and I believe even more activity with regard to share price manipulation or attempts to interfere with management plans to maintain ownership of the platform value in the hands of NWBO investors and not others would have occurred. This could have led to the point of potential bankruptcy or very cheap buyout if investors had known manufacturing was the holdup and bad actors were allowed to play with retail pretending to be rescuers for their own purpose. Linda asked for manufacturing help in 2018 and many investors thought that was a desperate move. How many would have sold out to the highest bidder over $3 back then knowing that manufacturing was going to be held up? Obviously many investors would have bailed or at least traded more in the interim looking for a better price and greater ROI had they known how long this would take and that would have created even more dilution.
There are several big investors and some smaller ones who likely have been trading in and out in order to increase their holdings or value of their investment over time. Those who help finance certainly know how to make money in the interim or minimize risk when shares and warrants have been part of the deal. Can’t wait to see the platform value move into the hands of long term retail investors as Linda seems to have planned for. Best wishes.
underpar71,
You are correct in your assumptions. The class C clean rooms have always been mentioned in conjunction with Flaskworks buildout at Sawston. Comparability and equivalence can be carried out in the class B suites but buildout requires a 2 year lead time based on what Linda has stated in the past so they are starting now because demand will rise dramatically and everyone involved knows this. The long lead time mentioned for some components of the clean rooms also fits within this 2 year time frame which potentially will be expedited by funds raised after any approval. This also is a hint that NWBO has no intention of selling out at an unrecognized platform value price or someone else would have joined in this part of the buildout. Interesting moves ahead. Best wishes.
learningcurve2020,
Why would FDA stop enrollment of SOC/placebo? Only two reasons and you know them. Safety issues or efficacy. Fraunhofer stated enrollment occurred to the point statistically necessary and there have been no safety issues in spite of “the look” that the DSMB took with regard likely to treatment induced pseudoprogression that had to be distinguished from true progression.
The bear argument about a futility recommendation that did not get overturned by improved OS with the understanding that treatment induced pseudoprogression was the reason for the original concern falls completely apart because of improved OS in both GBM and r GBM. The issue is that early treatment plus recurrent treatment is obviously the best regimen. Starting with SOC/placebo was obviously a less effective treatment regimen that had to be discontinued once the safety look was done. This is because Germany does not allow their patients to be placed on a lesser known treatment regimen for experimentation and they had all or all but one of the remaining SOC/placebo patients yet to be enrolled. The fact that you have not yet figured this out after so many times explained is telling; ). Best wishes.
hankmanhub,
😊. Best wishes.
skitahoe,
As you know Corning has had some past experience with Flaskworks so yes, there can be a scale up under the right circumstances which were obviously not in place at the time Corning sold their rights back. The cassettes will also be mass produced at some point. It was the initial layout that took so long and the GMP produced final product. We seem to be about ready to move at a steady forward pace with all of this and that, coupled with approval and reimbursement agreements, will put NWBO and partners on a logarithmic trajectory. Like I have said consistently, big pharma is in no hurry to announce that they have become second fiddles but when they are forced to because of NWBO achievements the fireworks really begin. Best wishes.
The Danish Dude,
I have been expecting something to be announced for years with regard to Dr. Mark Lowdell and INmune Bio and other ever since the picture of him, Linda Powers, Kristyn Powers and her dad who was a patient and now a long term survivor after being treated within weeks of expected death from rGBM. He has helped advance manufacturing of L past product release roadblocks too. Lots of lesser known pieces of the puzzle coming together right now. Great job and best wishes.
flipper44,
So it seems the reason we have been waiting all this time is the… manufacturing… manufacturing… manufacturing “bump in the road”. Mr. Neil Woodford said what happened with the hold was an expected part of development. However, this became a much more important and lengthy wait because of Covid and cost constraints associated with additional treatment of patients on a label that expanded from GBM to GBM, rGBM perhaps lower grade gliomas and probable significant off label use in trials which creates a much greater initial demand upon approval.
What happens to NWBO valuation when expansion to 12,000 patient batches per year to meet this demand, just at Sawston, is announced with FDA approval expected in 2025?; ). I’ll tell you one thing, the forward P/E ratio starts climbing real fast. Maybe Walgreens execs have a number in mind at three years out even if most big analysts have been encouraged to keep their fingers off the keyboards with regard to NWBO until big pharma gets their chance to play; ). Best wishes.
learningcurve2020,
First Lady Bayh had brain cancer. Do you know the specifics about that cancer genotype, how much was actually resected and stored properly that could have potentially been used to make vaccine which would guide on best path forward as well as whether or not DCVax-L was fully available to her at that time? Accusing is easy, backing the accusation up with solid evidence not so much. Come back with all the details if you can even get access to them. Best wishes.
Inquirig,
“If they are wise, do not quarrel with them; if they are fools ignore them”- - - Epictetus (Quoted by Inquirig)
You have given several here a great compliment by your inability to ignore us even though you lack the discipline not to quarrel; ). Thank you. Best wishes.
iclight,
No, I clearly stated Linda has options. You see while you clearly try hard to create resentment towards Linda Powers she is clearly working hard to get L then Direct to patients and that has included working closely with MHRA to move from artisan to more automated and enclosed manufacturing. This is obviously so stricter product release standards in the UK and EU can be met first before any other approval. This makes approvals elsewhere much easier to achieve, especially in the US where heavy influence from big pharma on FDA clearly exists but can be countered with demand from patients for treatment.
Mischaracterizing the motives of Linda Powers and others is what you do. Fortunately longs are for the most part not buying into the false light your perspective comes from because the truth here is more than sufficient to convince without taking a bite out of what you have to offer; ). Best wishes.
sentiment_stocks,
I agree. Linda has many connections to financing, research groups and much more. She always has more options than most bulletin board commenters are aware of. Best wishes.
beartrap12,
I don’t have the original building plan in front of me but the final buildout was expected to have 24/7 manufacturing with over 230 employees as I recall. That number may be in the 300s.
Right now Sawston has two B grade suites (suites being multiple clean rooms within) and 2 C grade suites of clean rooms either done or in the works with plenty of room for expansion. Once production of the GMP manufacturing units are on an assembly line the ramp up should not take too long. I would assume they are at least close to this position now.
Future clean room suites will likely be C grade with the existing B grade rooms used for both artisan and Flaskworks for comparability and backup. I defer to others who might have more experience with specific manufacturing development processes to point to a closer expected time frame for completion and validation based on the info we have in hand. Best wishes.
georgebailey,
Thanks, just saw this and your response of 50+50 monthly (1A and 1B) is the one basically mentioned by NWBO based on artisan methodology. Digitization and reduced footprint on space by Flaskworks vs artisan makes this much larger number possible not only due to space requirements but also reduced need for qualified personnel which has been a long time limiting factor and one that I have mentioned for quite some time now with regard to product release which NWBO themselves told us. Best wishes.
exwannabe,
😊. I think Advent is about ready to be able to treat 12,000 patients per year rather than nearly 4 year survivors… although treatment of lower grade gliomas and GBM/rGBM might lead to 12,000 patients per year as the new survival numbers get stretched out. At that point a push for a cure and not chronic treatment would be pressed for hard. Anyone working on that?; ). Best wishes.
iclight,
Devices are low bar and many wanted any tool available for GBM that might work or help something else work in at least some case situations. Some folks in favor of approving Optune talked about 5 year survivors being seen which of course is rare and that seemed to be enough for their support. DCVax-L has many more long term survivors and cleared a much higher bar with actual 5 year+ data. Nuff said. Best wishes.
flipper44,
NWBO and Dr. Linda Liau started with first do no harm and safety first then build from there. FDA is now looking more and more like a rubber stamp for big pharma and slow as molasses to approve safe treatments from small companies and just as slow to discontinue conditional approvals and dangerous treatments that they already have approved from big companies. Not a good look especially when obvious issues arose years ago, some of which should have been anticipated, and were not dealt with promptly. DCVax-L trials have been going on so long no one should have any doubt as to safety and improving efficacy being seen with tweaks and combos. Best wishes.
dennisdave,
I guess you missed the part about Walgreens preparing for DCVax-L distribution and point of sale instructions. I am pretty sure a franchise model based on Advent and perhaps CRL being training centers as well as manufacturing partners might be more than adequate to train big pharma franchisees. Linda also has other connections to get the help needed from and every trial site is trained in the basics of artisan administration and followup. A little training on how digitization works and good to go because these centers will be serving as the sales team as initial points of contact while eventual SOC designation will take care of much of the rest. By the way, this new language is in the risk section because of the likelihood of approval in the first place. Wrap your head around that; ). Best wishes.
RobotDroid,
The chart Sojourner55 showed originally of the current trend pointed to a continuation downward to about $.40 maybe even $.385 which is right around where May 10th 2022 took it to. When other comparative looks indicated that a breakout might occur this FUD not change the original chart. Everything depends on news and cycles within trends are happening too. Watch and learn. Best wishes.
exwannabe,
Come on exwannabe, own your “guess” and while you are at it your purpose for being here all these years. Inquirig minds want to know; ). Best wishes.
georgebailey,
There will be lots of talent looking to join the ground floor of the future in cancer treatment and well beyond. How long before Dr. Linda Liau and Dr. Bosch get their dues for what they have done with L and Direct. Best wishes.
Inquirig,
My grandkids sure think so!; ). Best wishes.
Inquirig,
You are having an extremely difficult time ignoring me like you said you would; ). Those who are the “smartest investors” know when to switch allegiances to maximize profits while minimizing risk. They aren’t ready yet and myself and others have been willing to take on the risk that they have not. My investment has been up and down in support of this company while theirs has mainly been up in support of making money all along the way. As maverick_1 is fond of saying, “different strokes for different folks”. Best wishes.
Inquirig,
My premise is that DCVax-L and Direct are already working well for some, will be validated as hugely commercially successful and that with that success your moniker will fade into oblivion. Time will certainly tell whether or not your contradictive viewpoint and premises will be sustained or not. I predict that your opinions, like dust, will be swept away with the winds of change created by approvals of DCVax-L then later Direct. Let time and truth be the judge and may memories not fade but rather be fully restored at the proper time for judgment. Best wishes.
learningcurve2020,
Why? Don’t you like my nice bright tie dye colors I painted the cabal tribe with?; ).
Inquirig,
Still having trouble ignoring me I see; ). How much less dilution would there have been over the last 9 years if a true white knight who understood the need for developing manufacturing breakthroughs and the time to develop that had stayed with NWBO to get past the big pharma and hedge fund cronies blockade?
For Mr. Neil Woodford this “bump in the road” was too much and his idea to move NWBO in a different direction was met with Linda putting him and his funds in time out. She knew what she was doing and kept full value of this platform in retail shareholder hands much to the chagrin of others who thought that their dirty tricks and lawbreaking actions would be enough to derail this plan and this company. Well Mr. Neil Woodford didn’t do very well compared to Linda which is proven out by the fact that he is no longer fiduciary of his former funds which collapsed while Linda has taken L to the approval stage with a worldwide “franchise” manufacturing model. That model can be implemented nearly simultaneously with approval since Edens certification has nearly caught up to the approval process. I would say that is pretty good preparation and logically sound when facing forces that would like to control the sea change coming but are now forced to compete against each other. These and other forces thinking to benefit from stock manipulation, perhaps designed to help those with the plan to control this change, are about to find out that pleasure for a season can end very abruptly and to greater detriment than the gain achieved.
I believe that longs believe Laura Posner and Cohen will eventually expose much of the plan to subordinate the plans of NWBO in the court of law and the court of public opinion for what it is, a massive illegal attempt to hold back a promising new treatment approach that harnesses the immune system of each patient treated instead of killing it off with poisons.
The above, in a big nutshell, is the cause of all this dilution that you constantly rant about being Linda’s fault. You like to blame Linda instead of give credit for this to those who worked hard to strip away institutional opportunity to support NWBO because of share price. Instead you give credit to these same who besmirch the names of those working so hard to bring a safe and efficacious treatment to patients who deserve better than the painful and debilitating treatments they receive now. You also enjoy emphasizing the obvious limitations that a small company has with such big ambitions. This is what you and the cabal do and you have made that your job here.
In spite of all your attempts, longs will continue to support NWBO because of the science that wins out in the end because there is a management team that can persevere. Linda has proven herself fully capable of this and will outlive your moniker on this board. That is a given that you and all those with you will soon find out.
Every long still accumulating at these prices and holding a few years will very likely be dancing in the streets, starting later this year in my opinion, and the party will last long after your moniker and many others with you have all disappeared.
Approval of vaccine MAA applications come in at nearly a 100% rate which you all know. Chew on that for a bit before your next post that deliberately fails to mention this while you complain about all the dilution that you and the gang want NWBO to take credit for instead of all the real perps; ). Best wishes
Inquirig,
Yes the stock is tanking as expected because of the forces at work which you represent and because current longs are pretty much saturated sponges just waiting for “the market” to become aware of what great due diligence on this board has revealed. This includes commercial scale manufacturing readiness on a global scale with franchising of the Advent model and big improvements in outcomes expected. This will come from what NWBO has learned in the interim, post Phase 3, about use of Poly ICLC and checkpoint combos along with CSF-R1 and proper T-cell activation/maturation with RevImmune’s IL-7 product.
By the way, “the market” represents followers in this case because retail has taken the lead, no big pharma can afford to pay the price this platform is worth and institutions are mostly being kept out of the picture for now because of the price which thanks to you and others is giving multiple generations in my family and others the opportunity to become financially secure and a blessing to many others besides when the expected news finally arrives and your moniker disappears; ). Best wishes.
Inquirig,
You are having quite a bit of trouble keeping me on ignore it seems; ). The PIP trial(s) don’t always have to start before approval but they must be prepared for. Try again. Best wishes.
sharpie510,
“Starting in 2025…”, cryo storage prominent at the end of the presentation. Not sure the cryo storage is needed for the other prospects listed in the 2023 piece. Definitely needed for DCVax-L and they have plenty of it; ). Seems like 2025 and the word “cure(s)” are cornerstones for this new division. Best wishes.
learningcurve2020,
Don’t worry about NWBO as they have had extensive talks with MHRA over the years and formally announced acceptance of the SAP which in those talks also would have included the rational for changes in primary objectives/endpoints which is why the PIP was accepted. Try another more believable distraction next time ; ). Best wishes.