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CaptainOblivious,
Good catch.Lol. Bobby Fisher was the chess champ recluse. Carrie was the princess whose brother was "Cool Hand Luke" ..Skywalker of course.
By the way, I'm a little surprised that NWBO didn't drop to around mid .5s to low .6s by today. Looks like the market still believes there is some hope to float the boat. Best wishes.
dlanglend 02,
Did the fat lady sing after Gary Kasparov and Eddie Fisher duked it out? Hedge fund strategy vs NWBO strategy. Who will get the combination therapy patent?
chinatown1980,
Chess match/poker game. Strategy and discipline in the face of apparent uncertainty is required for champions. Dennis Rodman types help create bothersome distraction for others while adding support to their team. Going down to the wire with science wins or bankruptcy. Linda said it this way "..go big or go home. Does the combination therapy patent bother you or anyone you might know? Some might not take too kindly to a leash around their necks.
sentiment stocks,
Exactly hmmm, hmmm.
Rkmatters,
You need to remember that there are more apparent methylated pseudo progressors with DCVax-L so the conclusion is they have magically found a way to skew their numbers. Let's see, about 4%-9% can historically survive to 5 years but now we magically have more than twice that number. Must be all that selection bias and improved surgical resection NWBO utilizes. That is why the NLNK 30 mo. SOC has the shorts licking their lips. What happens if the whole group (treatment and SOC) averages over 36 months OS and only minimal separation between groups? Now that would be really confounding as well as unprecedented.
For those who still believe that the science will win the day there is proof of this found in one line of the patent regarding combination therapies. From patent # US 2015/0273033 A1, page 5, 1st paragraph "[0048] FIGS. 4 A+B show that tumor lysate-pulsed dendritic cells down regulate expression of PD-L1." What this means is as long as activated DCs remain in the tumor or tumor cavity, regulation of checkpoint molecules is secured. Checkpoint molecules return when these activated DCs leave the site too soon. How do you fix this? Keep the injections at or about 2 weeks or combine treatment with checkpoint inhibitors. Now, why would big pharma want their hands tied like this?
I read that the FBI is working on 3 big fraud cases and that one of them is much bigger than the Bernie Madoff fraud. This was reported by the same person who told the SEC about Bernie way before any investigation was ever done.
kabunushi,
I second that salute to TC trader. We still have a chess match/high stakes poker game going on here. Best wishes.
Milou2,
That sounds like someone who understands the potential of the science and why the price has dropped so much based only on accusations against management and other fear mongering. I don't think Kevin represents Mr. Woodford though even if there was a "I took a shot but missed" or "I went too far" apology without saying so too. Best wishes.
exwannabe,
Did either of those trials have open label supporting evidence or a chance to verify benefit with anything like UCLA's assay?
Sub Atomic master,
Don't forget that just a few words from Mr. Woodford could take this stock in either direction very quickly. His silence is very telling as well here. There will be a coordinated effort to support NWBO or there will be conflicts of interest revealed with regard to one or even both parties. Mr. Woodford may have a top notch lawyer for more than just investigative offense. I hope his indirect public comments indicate otherwise but the silence is deafening while the scorched earth strategy between the 2 seems to be in play now based on the toxic financing and warrant exercise extension. I hope Linda shows up with some of that money you all think she has tucked away and the investigators might be looking at closely. She certainly doesn't need to give the blacklisters any more ammo because she still needs money to run her private business operations and maintain ongoing contractual obligations with NWBO related parties. Intersting times to say the least.
Rkmatters,
Something to ponder. If you were Linda Powers and had any doubts that L would get fairly substantial good news soon or might even be delayed or terminated, would installation of L capacity be a higher priority at Sawston or would fully automated Direct production lay out be more important? Also, if the Direct automation was fine tuned in Germany and perhaps previously tested and approved there, how much time would be saved to commercialization and overall approval? Remember, May is installation month at Sawston.
flipper44,
There are scouts (circulatory activated), generals (proinflamatory activated) and messenger (fully mature activated) DC states. The antigen activated proinflamatory DCs move to the tumor draining lymph nodes and intratumoral lymph type zones. This is what causes the additional Th1 inflamation which Pyrrhonian appears to have been unaware of. Spot on reply here flipper44.
flipper44,
This must be a mandatory part of the book and movie that comes out about NWBO. I lay out my claim to invest in its production and release here and now. LOL.
Rkmatters,
That earlier patent you laid out for us all has some really, really good clues in it as to how DCs might best be activated for cancer targets. The good thing for NWBO is that those clues are needles in a hay stack of verbiage.
Pyrrhonian keeps forgetting that much of what others were discovering and reporting on with regard to DCs NWBO already had a good understanding of with regard to DC activation. They just did not always openly tell anyone how what they were learning was all related. I stated quite a while ago that NWBO would never disclose all of the specifics of their processes in their patents. You have reiterated this point quite well. The patents simply have enough detail about their processes to keep others from using that part of it which would keep them from being able to know about the rest until those parts are added to an updated patent later on if needed to extend their control of the process.
Know-Fear,
That commercialization ramp up is exactly what Linda said NWBO would be preparing for. Other products are not anywhere near commercial application levels as far as I know and Cognate was paid for milestones by NWBO remember? Those milestone payments may have been for production capacity increase due to rapid German enrollment or other reason and or completion of full automation for Direct and or advances with automation for L.
chinatown1980,
I forgot to mention that the scaffolding project was only one part of a larger plan that described plans for other biologic applications. These other plans are definitely related to NWBO.
chinatown1980,
I remember reading a post regarding the Sawston building plan permit that described a use plan for harvesting stem cells from cadavers for use in building regenerative scaffolding platforms. This use appears to be for other Cognate operations than that correlated to NWBO but anything stem cell derived that is not described very specifically can not be completely ruled out as unrelated. Best wishes.
beartrap12,
I don't remember the exact post but I think it was from Jack or Longfellow95 that mentioned plans for installation of production equipment at Sawston in May and that all non related parties involved in other construction would be kept off of the property during this time. I'll try to go back and find it. Best wishes.
flipper44,
If I recall correctly, the turtles appeared to have no chance against the hare in the race to approval but somehow the 65th turtle won. When they interviewed him in the winner's circle they asked him why he walked all the way. He said "I didn't walk, I RANO". I think that was in the footnotes right? LOL.
Rkmatters,
I have what I like to call a relatively slow processor and assimilator sometimes but am long on retention so I pick and choose carefully the points I am willing to delve into deeply. What I have noticed is that over time there is a sub conscious connecting of the dots so to speak when I do this. That is when I dig even deeper to find confirmation elsewhere if possible.
Pyrrhonian has been quiet today and by my read that means he is quietly applauding you. He appears to have a different style of affirmation for you possibly because of ego but also because he may think his approval is something that you want or need and he can use this for leverage in debate.
Silence is his applause so smile.
john1045,
Shorts covering triggers sigificant buyins by others. Best wishes.
Rkmatters,
Pyrrhonian has a consistent MO now of leaving out key pieces of information when making his arguments. I have wondered at times if this is because he has convinced himself that he has learned enough about a particular subject to disregard additional input or simply wants a stronger argument to develop against his before he will concede a point. I don't mind his challenge as I believe longs should have the clearest argument for their position and we should be able to summerize it concisely along major points of contention. Failure is more likely than success in this arena so the burden should be on the longs and you have lifted this burden admirably here. I scored a few points against him over on SA a while back when discussing the need for injections to be spaced over a longer period of time and around every 2 weeks which is what NWBO later announced they would do.
I sometimes make mistakes but will quickly admit them if I do. I am here to learn and share. When Pyrrhonian goes quiet he has met his match whether he admits this or not. Let's see what happens today. Best wishes.
Rkmatters,
Pyrrhonian is having some trouble understanding the NDA timeline and the importance of certain patents as related to what Dr. Prins stated about DCVax coupled with antibodies like the checkpoint inhibitors. The reason that their patent will stand the test of time is that they have a foundational understanding of how to activate or deactivate diverse pathways from experience with their products. This will become much more clear with time.
sentiment stocks,
Propofol might be a more appropriate pain reliever for some indications but the emergency room doctor will need to make that call. First responders will probably need to use the defibrillator first. Best wishes.
hopefulsurgonc,
Feel free to ramble. This is exciting stuff. Just remember that Dr. Prins basically stated that cancer can be controlled or even cured with DC therapy AND an antibody like the checkpoint inhibitors in at least some patients. Very few know just how close we are to seeing a major breakthrough. Keep in mind that May is installation month at Sawston.
flipper44,
The more I go back and read the press release by NWBO the more I think that the Phase 2 trials being partnered are more related to L than Direct. The announcement is deliberately vague and the term Phase 2 makes us think Direct because that is the next step for the Direct trial. This could easily have been made clear but it was not. We know that NWBO can say nothing about L that seems promotional in any way. We also know that more is known about L than Direct. Safety, dosing and MO have been established for L so no Phase 1 is needed and the mesenchymal form of cancer is found in some cancer types more than in others. This would be a good reason to target 3 specific cancers using 3 different combos to see how each combo responds in different settings. I also thought Dr. Prins made a comment about partnering with L but not Direct at this point in time. The separate discussion of upgrades to Direct seem to point to working on getting Direct right and verified first before trying to partner it. Best wishes.
Adam,
How long until the scorched earth strike? What is the time frame based on your experience seeing this happen to other companies and your intuition? Do you think I will need to wait until September or maybe just until August options expiration? By the way, any update on the importance of CXCR4 you would like to share while we wait for real news? That grapefruit juice seems to be working pretty well in some of those Phase 1 patients.
Steppenwolf Speaks,
Normally I would agree with that comment 100% but with Mr. Woodford out for the time being and regulators with data, the price slides until news. It's getting help getting there. Best wishes.
Pyrrhonian,
The investigation came well after his meeting with management. The meeting with management was probably mostly about the hold but other info may also have been disclosed so I expect all that will be released at the same time if possible. Mr Woodford may be pressured into an early release of his investigation results but that would not be ideal for him. Best wishes.
Rkmatters,
Maybe that small, still voice after an "I've seen this before" moment? "You've got to know when to hold em..." By the way, "I'm goin down to the river, down to the river..." Best wishes.
DoGood DoWell,
Mr. Woodford's terms were at $5.50/share. NWBO's debt owed to Cognate was to be settled on the same terms and not more favorable terms than his as part of the financing deal. If options and warrants owned by NWBO/Cognate/Toucan eventually need to be converted to maintain voting control and Linda Powers and company can not convert enough because they are low on cash, this would give someone like Mr. Woodford an outside chance to take control. Before he or anyone else would do that, he would want key patents in an accessible position and he would want Linda's friends stretched financially. The value of their shares has dropped substantially so their borrowing power has dropped as well. Are you ready for a scorched earth attempt if it should materialize?
Rkmatters,
The way these collaborations are being set up seems to be an ideal way to test checkpoint inhibitors and perhaps engineered T-cells against one another. I may be misunderstanding something but each group will apparently test in 3 cancers and I would guess that Direct will also be a solo comparator against each product since it is being improved upon for Phase 2. I think they could enroll these trials in 2 weeks if they were ready and wanted to.
flipper44,
I'm pretty sure that the scientific advisory board will be carefully considering best strategy for endpoints and protocols, time frame for treatments and perhaps how to effectively alternate them to achieve optimum immune response and disease control based on known MOs and cellular cycles, and use of best predictive measures of response like the UCLA model. They will also look for the best readout measure(s) such as iRANO. Mostly, though, they represent a high profile validation of the science.
Rkmatters,
It's a good day for the future of cancer treatment. Patients need this treatment to get here yesterday though.
Always watch for how the price gets squeezed down when somebody big wants to load up. Best wishes.
flipper44,
They could announce a special convening of the board as long as sufficient advance notice is given to all shareholders so that they are aware that a vote will be taking place or they could ask for NASD regulators to simply allow them to put this vote on the agenda of the next annual meeting.
Pyrrhonian,
Mr. Woodford appears to have signed an NDA or is in a similar situation if considered an insider. He also has an obligation to his shareholders that must be fulfilled and part of that is being done with his investigation and not financing NWBO until his investigation report is published or he at least makes public comments about its findings. This is "professional" behavior.
Now let's consider the various forces at work in all of this. Let's assume for the sake of argument that there are only 2 extreme takes on Linda Powers' motivations. The bear argument is that Linda is only in this for herself and she knows that DCVax-L will fail and that DCVax-Direct is no better than grapefruit juice. The bears believe she has known this for at least 3-4 years (history of negative articles). The extreme long argument is that Linda Powers has 2 major long term goals for NWBO and they are to get DCVax (which she believes works) approved and to maintain personal control of the company. These longs believe the 1st goal is not left to chance if she maintains control of the company and that investors and traders who are waiting for validation of the science will be well rewarded when that day comes. With these 2 positions in place let's look at what happened last year.
NWBO was supposed to be in the process of failing as per the April 2015 puts that you are well aware of. The bears had been on a roll until Mr. Woodford became involved and put a monkey wrench into their time table. Mr. Woodford it seems had plans of his own which did not necessarily align with those who had been glad to see the stock price collapsing, nor with Linda's later on when the rift occurred. Mr. Woodford stated that he liked the science but remember, the bears stated case is that the science does not work. Bummer. Mr. Woodford had an interest in AZN, which is a British company, but has since sold that position after the Phase 5 report came out and his comments gave it legs which led to a rift with Linda. Even before Phase 5, the stock price had been in decline and so Mr. Woodford spoke with company management to satisfy his concerns. He stated nothing untoward was going on with regard to the company or its trials. So what forces were at work that had him so concerned in the first place? Evidently normal market shenanigans that he should have been aware of because he did not start an investigation at that point. Only after his embarrassing disclosure that Phase 5 had made him aware of something that he was not previously aware of did he start a public rift between himself and NWBO. So here we are, waiting for his report to be published or an all clear public announcement. Linda will not publish her report first because it is his move. I suspect Mr. Woodford will make that move if he is forced to by price action or at his convenience when the science is validated. By the way, the price action can be controlled by those extreme bears with Mr. Woodford on the sidelines. They need to be careful though, because Mr. Woodford might be leading them into another April 2015 type trap. Let's see when the next financing takes place. Musical chairs.
iclight,
As I see it there are 2 potential manufacturing issues. The one with regard to the PIM approval is related to expected volume from "early access" patients. This might be a low end to high end demand being expected by regulators. If they expect high end demand then production must be approved at or very near commercial level capacity before approval will be granted. The wording "able to supply the product" seems simple to do as your example suggests but the reality is that there is an unmentioned and expected demand supply level that must be met before approval will be granted. This is why we are witnessing a manufacturing ramp up in 3 countries. This L manufacturing ramp up may also be a clever smoke screen for Direct manufacturing ramp being done side by side. This would be a very clever way to surprise those who don't like surprises. If Direct manufacturing is up and running before the trial starts then how long would it take to get approvals and become commercially available? Just a thought.
The other manufacturing issue that might affect the trial and HE negotiations is a potential manufacturing change request related to producing more vaccine from the same amount of tumor or utilization of UCLA's screening technique is a non manufacturing twist to all of this as well. The manufacturing issue would require an equivalency test to gain approval and Germany may have requested this in relationship to the HE reimbursement negotiations to help keep cost per vaccination down and or give patients a better opportunity with more vaccine produced. All regulators would need to be on board for this to happen. In the mean time, OS eventing continues in hopes of seeing a clearer separation between early treatment vs late treatment patients.
iwasadiver,
"You've got to know when to hold em, know when to fold em, know when to walk away and when to run. You never count your money when you're sittin at the table. There'll be time enough for countin when the dealins done." Kenny Rogers from The Gambler
iwasadiver,
If there was ever a trial that patients might be willing to pay to get into, the Direct Phase 2 would be it. There might also be some understandable special interest in what is going on by those known for making documentaries. If I were Nat Geo management (I am not), where one of my own was living testimony, I would certainly be interested in following this technology very closely.
antihama,
Manufacturing is an issue for the Europeans and the PIM approval process. The second part of the approval depends heavily on manufacturing standards and commercial production capacity. Best wishes.