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Turtle65,
I know of no circumstance that would allow a trial to continue without disclosing their primary endpoint completion. That 248 event point must be disclosed. Gathering data beyond that point with regard to OS could be finished after that but not without disclosing that primary point in the first place when it occurred. If longer we wait for this event the better the results will be proven out to be. The better the results will be the greater the demand will be. The greater the projected demand will be the more manufacturing capacity they will need to show they can handle and the more pressure will be on everyone, regulators included, to be ready, up and running. The "turning good news into bad" comment puts NWBO at fairly severe risk, especially in light of their ongoing independent investigations, if they received a recommendation of halt for futility and that led to the screening halt. The news that will drive the stock price up in your scenario is no news over the longer run since the 248 events are not being reported while financing news causes a correction every once in a while to the upside projections. I still think the market makers are planning for about a 2 to 3 month double bottom gap which is typical for where we are on the charts but let's see how Linda plays this. Best wishes.
md1225,
Knight Capital, skull and crossbones on the pink sheet and UBS (Suisse international bankers). Now where have I seen these connections before? Knights Templar perhaps? Hmmmm. Best wishes.
sentiment stocks,
Remember what the UCLA correlation to survival revolved around? Dr. Prins specifically talked about the relationship of previously existing tumor born T-cells to circulating T-cells in the blood that had the same markers. In general, these would be killer, helper and memory T-cells with the emphasis on CD8+ killer T-cells and memory T-cells . When their activation switch is essentially turned off, they still circulate or remain in or near the tumor but lack the ability to aid or attack the tumor as their switch is basically in the off position. Activated DCs can have the ability to get the switch turned back on by exposing them to the antigens again in the right environment. Antigen presenting cells that drop their load can also go back into circulation until they come to the end of their life cycle after about 3 weeks. This recirculation of activated DCs helps catch the neoantigens in their vulnerable migration/establishment state which is related to mesenchymal genetic activation. In the tumor environment this life cycle time drops down considerably in most cases. NWBO has found a way to keep them active a little longer but they still won't stay there much longer. Best wishes.
antihama,
That would be the conventional thinking up until DC therapies were found to be more effective with mesenchymal genotype and phenotype. DC treatment can reactivate existing blood born and tumor born T-cells and that in turn can identify neoantigens that remain essentially exposed during migration and initial establishment. This is what makes the crossover such an important aspect of this trial. In a word, reactivation. Best wishes.
Dan88,
This is another reason I stick with NWBO through thick and thin. There are 4 ways we all can win. We can win with knowing we have tried to help cancer patients, approval of L, approval of Direct and possibly big money from a civil lawsuit as a result of what the investigation turns up. Best wishes.
BuyWhenISell,
Most of us would be scared to buy in this situation but like we all know, some find a way to do it anyway. Best wishes.
doingmybest,
If anyone goes public with an offer that has not been signed, sealed and delivered, the price goes exponential from a stampede. If all sign agreements before media attention they and their "friends" have a chance to own a piece of the company through others before the price explodes. The recent massive volume points to something along this line of reasoning. Short covering would be included in this as well. Best wishes.
flipper44,
They don't want to create a stampede before results or they will show retail that they think NWBO has the goods. If Linda says no to a buyout after they make public offers that stampede will push them over a steep cliff and there will be beef for dinner for a long time. They work on Linda's terms or they get roasted. She owns them because Cognate is private and patients, advocates and everyone else won't allow this treatment to be taken hostage. Best wishes.
longfellow95,
The low dose cyclophosphamide has been used in other immunotherapy trials and appears to work well. What I think they may be doing with this is to try and see if they can get patients that are the most immunocompromised like those that failed early in the Phase 1 back into a treatable state that can respond quicker to initial Direct treatment. They may expect that this will not be needed in earlier stage or better prognosis patients eventually but might expand the treatable patient population for labeling purposes after approval. Best wishes.
barcode27,
Seems like this restricted patentability is taking NWBO a while to deal with. Maybe a job for the scientific advisory board and NWBO to work on together. Best wishes.
maverick_1,
The AZN connection to Mr. Woodford has been a key driver for my own views about his motives with regard to NWBO. He has stated his desire to keep Great Britain at the forefront of technology and help create and keep good jobs there. The fallout between NWBO and Mr. Woodford is, as you say, on him because of going public. The Ondra situation is on him even if some view it as a minor oversight blown up by NWBO into more than actually occurred. The fact that sensitive notes were returned is enough to have doubts about motives until the investigation helps lead to firmer conclusions. Until there is further clarification, his actions must be considered to be part of that investigation until they are declared separate by investigators. flipper44 may be right but I believe both NWBO and Mr. Woodford are acting appropriately under the circumstances and, apart from being insiders, they may both be acting on advice from legal counsel in this regard until the investigation is done and results revealed. I had thought it was an NDA but legal counsel or just good old prudence makes more sense now. On a separate note, I still like Roche's PDL-1 inhibitor. Best wishes.
Jack2479,
That is a good starting range for early on. Once the platform is more fully explained as to how it can be used in other cancers and early Phase 2 Direct results come in that astound, then the valuation begins the climb to true value. Best wishes.
BuyWhenISell,
Approved drugs can be used together at Dr. discretion. The problem is determining reimbursement rates from insurers. That would still need to be worked out. Self pay would have no problem. Best wishes.
flipper44,
Do you mean to tell me that analysts were using that and other meta analysis to put in the recent bottom and start pointing the arrow up? Gee, I wonder how they ever figured that one out. Pyrrhonian where are you when we need a good bear argument? Best wishes.
BuyWhenISell,
Let's look at what we do know and what might happen because of it in the simplest possible scenarios. First we know and big pharma knows that DC treatment potentiates checkpoint inhibitors. These pharmas can either look at NWBO or look for other DCs which may or may not work as well as DCVax in their view. If they skip this approach they would need to experiment with other therapies for use in combinations where safety might be more of an issue. DCVax-L is already a good ways through the path to approval and if Direct moves into registrational status, utilizes optimized endpoints and receives an SPA it might be too. The shotgun approach takes a good deal of time and DC therapies close to approval are very few. If they can get their products used 3× more while perhaps using less product with a better safety profile in a relatively short period of time with potentially 2 types of DC treatment vs having a big question mark in front of them for quite a while, what do you think will make the most sense to their shareholders who also have their own experiences with cancer?
Now is the time that pharma has some leverage with NWBO but if Linda plays hardball and we go into extra innings that leverage will be lost if L is approved before they strike a deal. In most cases, pharma would want better validation but they basically already convinced themselves. Hardball could hurt investors in the short run if potential partners balk at Linda's terms but if NWBO begins monetization without a deal the potential partners could lose in a much bigger way. Their worst case scenario would be if NWBO monetizes and the investigstion finds one or more was found to be playing dirty with NWBO. I really hope this is not the case. Best wishes.
Evaluate,
When the scientific community begins to turn from cautious optimism to making projections about future impact they have seen enough evidence on which to base their conclusions. The investment community generally follows just a ltitle behind to take into account development lag costs and time for partnering or buyout interest to develop. The more obvious that a deal or deals become likely the more investment interest is drawn to it. Cautious optimism is the rule of the day. Best wishes.
Best wishes.
maverick_1,
Thank you for this forward thinking post and the highlights you showed us that pertain to DCVax technology. Best wishes.
Jack2479,
Sometimes I am much more thoughtful than others. Please feel free to real me in anytime as a good challenge tends to help me rise to the occasion so to speak.
On a separate note, have you heard or seen anything new going on at Sawston? The board really appreciates your input on this. I know that without much money things have probably slowed down but please keep us posted as you have the time or inclination. Best wishes.
Jack2479,
I share your desire for more clarity but that does not mean we will get it. I'm also glad you see the silence as probably imposed by legal counsel advice. Part of what Linda has been accused of is overstating or over emphasizing certain data. My comments about her silence with this in mind referred to this as fear of more accusations of pumping being made. If anyone can get management to be more forthcoming bravo. My point was and is that we control what we do with our investment and risk but we don't control what management will tell us. There are several who have shared their own strategies to mitigate risk and still support NWBO. I was just trying to point out that for those who are stuggling with NWBO's strategy of silence there is something everyone who really wants an answer can do and that includes sharing with them their potential options as a shareholder.
I tend to think that strategies of small biotechs that are under attack should not reveal much. Those who oppose them already know many of the hurdles that must be overcome and use this to their full advantage so no reason to give them more ammo. The first goal of any company is survival and that means getting to monetization before bankruptcy. NWBO used to give more updates but some shareholders expressed their desire for the company to remain silent because attacks inevitably ensued. They may bir have anticipated being silent this ling but the silence is what it is. Minimal PRs until big news is now the obvious strategy. I think they have answered that question loud and clear.
The best judge of their performance will be hindsight although they have made some mistakes along the way which they have acknowledged. Even the courts are waiting for the independent investigation to conclude before judgment is made about their performance. If the courts must wait for clarification then maybe just maybe that means all the rest of us will need to wait as well, whether patiently or not. Best wishes.
Jack2479,
The news will continue to be neutral until something major happens. Any style other than neutral presentation would add weight to the legal challenge claims against management that they are trying to pump this for personal gain. Their lack of news is probably not just to appease regulators but may also have to do with the morphing you allude to. They may have been asked to remain as silent and neutral as possible for investigative purposes. There are good reasons related to trading volume for believing that this may be the case.
I agree that we all need news but we also need a personal plan with regard to our risk tolerance that includes considering adjusting strategy. Some have stated that they are trading in and out with a part of their position. That is not for me but my situation is different than yours. Linda will do whatever it takes to get this across the finish line. Longs all need to be flexible enough to meet her there. Best wishes.
sentiment stocks,
Excellent post. Can't wait for the part where Paul Harvey chimes in and says "And now, for the rest of the story." Best wishes.
learningcurve2020,
FDA will almost never peek until there is no more plausible explanation. The DMC may have recommended a halt but until a median can be established for actual benefit, the company has a right to keep everything continuing to insure best benefit outcome. FDA can change things up, though, if they have reason to believe some group is being placed in a less advantaged situation and median will be reached without adding any more to this group than necessary to preserve the integrity of the trial. Best wishes.
flipper44,
By the way, my thoughts leave me to believe that cell selection may occur before and or after activation. Best wishes.
flipper44,
Great post. As you have basically pointed out, cell selection, activation, amount, number of tumors injected and spacing of injections are the main keys. Looking forward to Phase 2. Best wishes.
hopefulsurgonc,
Thanks for your honest perspective. Taken as written the press release definately leaves room for skepticism. Your experience is proof enough. I do, however, believe NWBO is pointing to data that leads to the focus of their Phase 2. Best wishes.
longfellow95,
I believe you are also correct in stating that NWBO is not sharing all that they know. This is what I meant when I said they are holding their cards close to their vest in one of my earlier posts. Rkmatters is also correct in stating that progression as measured by standard measure allowed patients to move off treatment. I am not sure if they could petition to remain or not. Remember this,though, immunologically speaking only the first 3 treatments were spaced within the parameters of sustained effective treatment and there were 2 methods with 3 different cell counts each. Once you add these factors in to results, the top 20% being reported on makes sense due to better method and better dosing. They just didn't say this. Some would argue that they didn't say this because they couldn't but that would be less warranted speculation than what I suggest since they indicated method and cell count preference earlier. Best wishes.
Evaluate,
DC subtypes are related to source, maturation environment and activation. I won't say more than this as NWBO still wants to hold their cards close. What I will say is that there were 2 activation types utilized, 3 cell count amounts, only one tumor injected and deliberately suboptimal dosing schedule utilized. Once you account for best activation and best cell count you will understand the very positive ramifications of the charts better toral number of patients divided roughly by 5 to account for the various grouts aND numbers in each one. Also, many still do not understand why the suboptimal injection schedule caused suboptimal results in both types of activation. Best wishes.
Truthfan,
The confusion was not caused by you but by me. I agree with your assessment which my thought process jumped right past to get to adding that NWBO probably won't need to be a paying customer for quite some time. Looking back on my comment I see it looks like either a misundetstanding on my part or some kind of one-upsmanship which was not my intent. The point I was trying to make is that only those that report early, like Fox did a while back, will get any early benefit or potential nod from NWBO for future interviews or advertising. The problem I see is more about the potential for too much demand than a need for advertising to create it whether there are partners involved or not and as you pointed out this will affect advertising revenues. Best wishes.
iwasadiver,
You said "This is bigger than what most can grasp I believe." You are absolutely correct and this category includes some of the world's sharpest minds because they have been focused elsewhere. This is why I have been supporting this technology and company by holding shares and adding over time in spite of knowing the opposition would try to bring this company down. Best wishes.
iwasadiver,
To tell you the truth, I am a little giddy about what I think I have found and yes I do know the difference between fools gold and the real deal. I learned lots of cool stuff in 5th grade.
I hesitate to reveal too much because many have poured their lives into all of this and I certainly don't want to give competitors a chance to catch up but I am sure my comments with clues have caught the attention of several folks. The bottom line is that very specific types of differentiation matter with regard to DCs and other cells and there are certain clues from various sources about what NWBO might be doing to make their DCs special. For NWBO the differentiation that matters most is done ex-vivo and is therefore not naturally ocurring. This makes it a strongly patentable process. Anyone can mature precursors to DCs but they can't mature them with the exact same properties that NWBO can. Anyone can make a cola but only one company can make Coca Cola. Now add to this Triozzi et al's observation that intratumoral injection of DCs helped to temporarily change the tumor microenvironment and that intratumoral injection coupled with intradermal injection appear to be synergistic and you have the reason for my investment here.
There are a few key steps along the way to success and I believe I researched my way into stumbling onto 3 of them. Activation and the intratumoral setting sets Direct apart and additional research could eventually lead to at least semi standardized vaccination. With regard to DCVax-L and brain tumors, the immune system must work efficiently and at a much slower pace than what can be achieved using certain other immunotherapy methods so as to prevent dangerous swelling. Apart from this situation Direct or Direct/L could eventually be used to treat all other solid tumor cancers and most likely at almost any stage except perhaps very end stage cancer but spacing of the treatments appears to be critical for this to be achieved. Again, the type of DC is important and there is at least one subset they found in the Phase 1 Direct trial that NWBO is very excited about. Best wishes.
Truthfan,
I think you are forgetting about all the lost revenue from advertising when word of mouth creates more demand than a company can keep up with. The initial "first to report" pop will help with credibility for viewers. If FOX is first to report based on a follow up piece from several years ago, then they will get lots of hits with replays and their medical segments will be seen as more newsworthy and forward thinking than those of other stations. I can't imagine Nat Geo being left on the sidelines either. Best wishes.
Evaluate,
I understand the challenge you are making to md1225's statements which is legit because the rest of us have no way to validate them. You have called me out on a few things too which is good as it keeps me from being lazy with regard to my comments. What I find interesting about md1225's comment is not that I can find those supposed doctors to validate what he says but that there are no doctors commenting on the record negatively about the chances for success. This was not the case when I was following VICL before it crashed and burned. There were also plenty of folks on this board who did not think IMUC and CLDX would win the day either. I wonder if you or anyone reading this message has found any negative comments by oncologists or immunologists regarding NWBO's DCVax treatments. I have not and to me that is telling. Best wishes.
Welsh Dragon,
The price drop you speak of can be traced to accusations made against the company leading to public expression of doubt by biggest financial supporter (Mr. Woodford) leading to poor financing options and silence by the company generally believed to be a result of lawsuits and or resulting attacks on any interim news as part of an ongoing smear campaign against the company. Best wishes.
Rkmatters,
Good reminder. When doctors treating a particular disease on a constant basis say they like what they see or apparently all patients are living longer, it pays to listen and wait patiently. Best wishes.
flipper44,
Allan Butler's work profile says he has been VP since 2013 (3 years, 9 months). There is one so called data point for you and I am sure there are others from lung cancer patient, sarcoma patient etc. Validation coming in some form. Best wishes.
sentiment stocks,
Nor should we forget that just like changing the environment at FDA, tumor environments are probably best changed from the inside out. Best wishes.
Rkmatters,
You stated in speaking about NWBO differentiated DCs compared to those UCLA used "I'm expecting that will make a difference on why patients are living longer". Me too and also the dosing schedule and crossover. Best wishes.
iwasadiver,
You may be correct about Direct batting cleanup but my research has led me to believe that Direct alone, if given the proper parameters for use, may have the ability to go solo with almost if not all solid tumors. I believe this is part of the reason for the delay as they probably wanted a better consensus opinion about trial design, potential combos and perhaps endpoints. By the way, I think I have a pretty good idea why so many potential sources of DC precursors are listed on the patent. Best wishes.
Evaluate,
Hopefully the Dutch get a little nod out of all this due to the critical contributions of Dr. Marnix Bosch. This would be a great team Nobel Prize opportunity. Best wishes.
eagle8,
You bet and I hope you read evaluate's post as it is more specific. Best wishes as well.