Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Turtle65,
Glad it helped you. Hope you Linda and Les get things patched up before the get together you mentioned a while back. I heard turtle number 65 wins his race against the hare and we can't have Linda and Les all upset about having to bring 100 bodyguards along when only 10 are needed to protect against big pharma and the hedgies. LOL. Best wishes.
md1225,
You are entirely welcome. These are just my thoughts based on market experience coupled with an attempt to logically take into account the historical time frames for regulatory decision activity, negotiation strategies, scientific evidence, manufacturing ramp up and what is at stake here. Best wishes.
afford567,
I understand your point well and agree that this could be possible. I also believe that there is enough integrity involved from who the investigators are to see one or more resign if they felt NWBO was trying to cover something up. My main point with agreeing with austinmediainc was that there are at least 2 investigations going on with regard to NWBO and one or both should have had something to report by now unless they were asked not to. Mr. Woodford would have reported on behalf of his investors and NWBO on behalf of theirs. This seems quite apparent. The fact that this has not happened in the face of deep losses over an extended period of time indicates that there may be something much bigger going on. The evidence continues to roll in that DC therapy and checkpoint inhibitors in combination hold great promise. NWBO's combination therapy patent, therefore, holds great value. The stakes at this point could not be too much higher since the Phase 3 trial has a planned ending in September and August marks the one year anniversary of the screening hold. This is an "all in" moment for both sides and that means winner takes all soon if an agreement is not announced soon. The agreement tease appears to be a backup plan for big pharma if NWBO can't be squeezed out before something big is announced. This creates the kind of tension we are currently witnessing. Keep September in your sights even if something should happen sooner. I believe this is the tension stretch period. Best wishes.
TiltMyBrain,
The goal, I believe, is overwhelming evidence with or without Martin's help. Then they show Martin his options, most of which do not include "Club Fed" or the witness protection program. I have a feeling a few legislators might be interested in their options as well since this all goes back to how the laws are written and who is taking advantage of whom. The FBI is still one place where some altruistic Americans reside. Best wishes.
austinmediainc,
Frustrated as we all might be to some degree or other, you are right about length of time needed to clear NWBO or refute Phase 5 report. Mr. Woodford is doing his own investigation as well so there are at least 2 potential sources of information from investigations. Should they both be taking this long? I don't think so but unraveling the connections between potential outside conspiritors probably would. NWBO is not the only biotech checking into price manipulation and the FBI is working on at least 3 major fraud cases right now, one of which will make Bernie Madoff's scheme look like child's play. I would not be surprised if the FBI is asking for all info being gathered from all sources with regard to this issue and asking investgating companies to remain silent while they build their case.
The recent supreme court decision that will allow individual states to hear company and investor complaints against manipulators is the first hint at what might be a big change coming in favor of the little guys.
Rkmatters,
I believe the B-cell activation of T-cells and or trafficking of antigens to the lymph zone for DC/T-cell interaction mentioned in your post may be something NWBO eventually talks about as well. Best wishes.
iwasadiver,
The key to regulating checkpoint pathways may all boil down to one very conserved and inescapable signaling molecular relationship which I believe NWBO understands very well. This is the reason their checkpoint combination patent will stand up over time and is a thorn in the side of big pharma and their investor advocates alike. Best wishes.
Doktornolittle,
I would really be excited to see an intratumoral checkpoint inhibitor/Direct combination trial even though Direct may be good enough on its own. The Phase 2 trials could be with either product or both but I'm leaning mainly towards DCVax-L only because more is publicly known about it and I believe comments made by Dr. Prins point to DCVax-L.
DCVax-L vaccine quantity is limited by tumor mass size and potential for unresected tumor being the location of additional key antigen targets. Production improvements have been made to maximize the number of vaccines made from resected tumor but if best dosing interval is much shorter than previously thought then even this additional vaccine may not be sufficient to reach optimum results. Checkpoint inhibitors should effectively act to stretch out the effectiveness over time of each vaccine. This should essentially allow enough time for residual tumor to be cleared from tumor cavities after resection as well as help prevent escape and possibly lead to immune memory with heightened immune surveillance imparted. Eventually UCLA plans to isolate key post DC vaccine activated T-cell subsets to be cloned to produce a DCVax adjuvant therapy. In the mean time CI combinations with DCVax should work fairly well to exceptionally well in most patients. Best wishes.
Doktornolittle,
This lymphocyte count correlation is significant not only for absolute count at screening but as it relates to longer term recovery to higher levels with time. NWBO wanted to make sure that those who could recover to higher levels were not having their results dragged down by those whose immune systems were being compromised because their lymphocyte count could not rise much over time even if their absolute count allowed them into the trial in the first place. As flipper44 said, SOC does not benefit from better lymphocyte count until they cross over so PFS benefit should correlate to prior lymphocyte count fairly well in the ITT population. Lymphocyte count may also correlate to the immunogenicity of the tumor type as well. Lymphocytes want to get to exposed tumor antigens and have the ability to access submerged antigens that will surface under the right conditions but are prevented from this activity because of improper activation due to cancer defense mechanisms. DCVax creates the right conditions for a short time with each vaccination. The improved dosing schedule, cell count and multiple injection sites will help.
Keep an eye on developments at Sawston. Just because NWBO may not be able to say much now does not mean we can't put expected time tables together. Three Phase 2s with rapid enrollment expected needs production ramped up and ready to go. I would imagine that best potential improvements (some may have been suggested by Dr. Linda Liau) will be built in as well. Best wishes.
Pyrrhonian,
Your analysis is indeed the normal course for small bios. In this situation, however, NWBO is sitting on news. They have news about commercialization preparation from Sawston, Memphis and Germany that is obviously tied to the regulators. If they are in the process of amending endpoints, this information could be released and according to those who see NWBO taking every chance to pump that they can, this update should have been publicly released already.
Steppenwolf Speaks,
You have been right about the stock price trend over the last 18 months as you stated so kudos there. This is an investment site so your perspective should be viewed as valuable since time has proven you correct. I have also said for a while that a scorched earth effort to drive this price down could well take place. Earlier this year I suggested news would probably come either in March-April or not until September. This view is based on historical active periods of regulatory agencies. The "Sell in May and go away" crowd has obviously made their presence felt in the recent weeks with NWBO as well so why the slow burn down from those who are negative on this stock instead of all out attack to force an earlier reverse split or bankruptcy possibility? Are they meeting resistance? We know NWBO will need cash again before September and that a reverse split could be held off until then based on a 180 day allowance to regain compliance once a price noncompliance letter is sent. This notice has not been given yet due the short period of time that has elapsed with the price under $1. With institutions accumulating more than selling, as I suggested might be happening and you countered thinking that this was not so, the evidence seems to point to a range bound cycle or even a rebound sometime in the next few months. I am sticking to the September or slightly sooner time frame due to the investigation report possibility and need for funding perhaps forcing the issue to some extent. What do you think?
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.