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exwannabe,
My post was in response to recurrence after potential treatment induced pseudoprogression which was I believe monitored for almost 3 months in cases where progression could not be fully confirmed before crossover treatment began.
I agree with you about chemo/rad induced pseudoprogression from SOC which both arms would have been supposed to be impacted by equally in terms of percentages. The issue is that treatment amplifies benefit in almost all of these cases such that comparable non treatment data still lags significantly behind the treatment data and this is made especially clear in the rGBM data where chemo was reduced or eliminated during course of treatment. These factors were all considered carefully by JAMA Oncology hence conclusions were validated by peer review with publication. Best wishes.
CrashOverride,
Amplification of vaccines made from same amount of tumor material increases the number of patients qualified for use and potentially longer term use if less tumor tissue can be utilized for making the vaccines. More patients qualifying for treatment is the goal and being able to utilize any significant amount of cells otherwise lost helps do this. Any additional improvement in purity improves signaling too. Best wishes.
CrashOverride,
The most consistent results from a combo trial will come with closed system manufacturing. With early results from the combo trial possibly ready to share after the January primary completion date has come and gone, the relative importance of L vs checkpoint inhibitors becomes more clear and getting optimized results from greater purity and optimized cell production and recovery creates a greater number of patients able to receive treatment vs artisan. Having those issues cleared up before a trial can make a big difference in results and number of patients qualifying for treatment. Remember that the Phase 3 required a minimum of 5 treatments being made. The combo trial requires only 3. Best wishes.
attilathehunt,
Reimbursement is a big deal so news needs more news to inform the broader audience. There is interim funding for those in the UK until a NICE decision if it is not simultaneous but anyone else from outside that zone will need to self fund. Best wishes.
FeMike,
Bravo!; ). Still, the unexplained is the unexplained so this kind of guess work is not out of the question until more fully explained whether it really does have anything to do with each other or not. Low odds does not mean no chance so I say let us dreamers dream big dreams as long as we don’t try to trap someone in them just for our own benefit and the science is still good. Dreams and science got us to the moon ; ). Best wishes.
Foogie88,
In this case “appearances” are meant to be deceiving just like the constant bashing without regard to the science and validation of it which goes on constantly here to support the appearance. If you had been around here years ago one of the “intelligent bears”, AVII77, laid out the case for failed PFS being good as a contra indicator that pseudoprogression was leading to an improved overall survival. Well as we can all see from how the trial data was presented in JAMA Oncology, this is exactly what happened and he said this was a good thing because it is. Notice that AVII77 never posts here anymore?; ). There’s a very good reason for that because all the rest of the bashers do NOT want to deal with explaining this away day in and day out ; ). Best wishes.
manibiotech,
We are in between news cycles which is where the price holds or drops usually as traders pay strict attention to time value and that is more pronounced in OTC stocks that generally have a bigger change from highs to lows. Once hitting lows first highs can be a 100% increase from there in a year to year and a half just on interim price movement. In the position we are in now, before binary news, an initial 150% -300% price gain in one day or more is possible. I have seen a 400%-500% gain by the time settlement occurs after news. Gains from approval will be dependent on manufacturing, partnership and actual revenue projection news. Spec value adds to the run once a path to widespread scale up is validated and the pathway to tissue agnostic designation is clear.
The question for NWBO this time is how will they manage the news if mostly impeded in the US due to OTC position. I would hope they have a good strategy with regard to partnership announcements but if not able to announce yet then at least interviews with Linda Powers and Mike Scott at Advent in Sawston as well as Dr. Linda Liau as a member of the scientific advisory board. Cambridge news outlets likely will pick this up and run with it and UCLA and Brown University might promote Dr. Linda Liau’s role in all this as well. Cambridge development authority has shown they want the attention and are willing to be a big voice for their community and perhaps to the world with regard to Advent. Getting word out through Al Musella and other patient advocate groups will help too. At some point major media in the US and elsewhere will not be able to ignore the news either.
The markets will respond because traders want in on any volatility they pick up on which will happen in a big way within minutes to hours of approval news. In order to sustain momentum in a push to over $5 and uplisting NWBO and Advent will need to make projections about sales, share contract news with Charles River Labs and Advent or provide news about a partnership. No other good way to get price support. Solid evidence for any projections must be given by a trusted outsider and this needs to be in hand or any projection announcement will be torn apart based on past forward looking statements made by management that did not hold up. Mike Scott would be the one to speak for Advent and their projections. I expect his to be a voice that is listened to and respected because he carries no baggage from the past even though Linda Powers and Toucan own Advent. Best wishes.
Smitty5150,
Not completely true. Inquirig and exwannabe manage not to respond to my posts for the most part now and others will likely get to that point too. I often remind of things that they don’t want the board reminded of when they do respond to me which can make their efforts counter productive. By the way, I don’t respond to all their posts either. I kind of pick and choose depending on how inspired I feel about trying to respond. Best wishes.
norisknorewards,
Maybe Merck and Amgen have known about this for a while and have been preparing to take advantage when the DCVax PLATFORM comes on board by overwhelming demand; ). Maybe Congress and regulators figured out that they need to get out of the way by the time that happens. Best wishes.
theorysuit,
You are the shamer paid to have no shame. The science says so and JAMA Oncology backed the science, the measures of treatment effect and the conclusions. The science says shame on theorysuit and power to the patients.
Oh what I would give to see a video of surviving patients and their families surrounding you while you tried to convince them that they should be ashamed for being alive after treatment with DCVax. Maybe that might be your “come to Jesus moment”. Best wishes.
exwannabe,
Your post brought a smile, almost a laugh. The bluffing by you and others is so forced and obvious now that no one needs to do anything but call your bluff and they are a winner; ). Best wishes.
Inquirig,
Wrong!; ). Again: (. The price went to $.14 because of lies about the screening halt and forced fire sale prices of shares when Mr. Woodford was left on the outside of his funds and a new fiduciary had to step in to sell all his NWBO shares. The double bottom happened while waiting for data to mature fully and manufacturing to advance towards realistic longer term expectations of meeting demand. NWBO found a way to stay alive and now your bosses are hoping for a way out of their predicament. They need a guy like Houdini or David Copperfield not you all ; ). Best wishes.
Sentiment_stocks,
I always appreciated that effort to get into the weeds on this topic and believe you are correct. Even if some of the complaint of the bears seems justified in the eyes of some there is still the fact that this company found a way to survive at a time they were really vulnerable and that deserves some credit which the bears gladly refuse to grant. Best wishes.
learningcurve2020,
Nope!; ). That “concern” is why first in man designation was given to Direct but also why autologous DCs have been the ones used to date even though the patents allow for matched donors just like blood donors and recipients are matched. The “concern” did not really take into account how the DCs are activated and matured in a way that imitates what happens in vivo. Unlike CAR-T cells that are activated without concurrent activation of the complimentary immune system response, DCs get support from and give signaling to the rest of the immune system. Stick to the script because you are just guessing on the science and it shows…badly. Best wishes.
SingleStock,
The first two are the ones to carry this forward towards max recognized value along with Navid. Jerry and the others have valuable connections but can safely retire at any time knowing that they helped achieve something truly remarkable. That time likely begins after approval of L since that is the first big validation point that I assume they all really wanted to cross over the finish line together at. Dr. Alton Boynton represents the history point where DC trials first began in the U.S. at the hospital he worked at. Dr. Bosch represents the next Gen of DC therapy with Direct. Linda represents the entrepreneur that brought it to fruition with the help of Navid who brought in the big backer that allowed the trial to be completed years earlier than otherwise possible with only retail funding. There will be some very interesting moves made in the not too distant future because Linda Powers has been writing the book about and modeling how to run the biotech gauntlet with a big winner and survive without giving away all the goods. Best wishes.
Inquirig,
Why are you so concerned about dilution when you own no shares and approval brings a greater than 10X jump from here? The PIP SAP is based on same model as Phase 3, a global manufacturing model is nearly fully secured, MHRA approval is expected (vaccines approved at nearly 100% rate after submission) to be prioritized and done between 80 and about 255 days post submission (March to September 2024) and the combo patent has been granted in Europe where initial approval is expected to come from. This puts NWBO in the driver’s seat as to which pharma(s) get access to their treatment in beneficial combo form and NICE reimbursement decisions can be and have been timed to coincide with approval. The 17 missing SOC/placebo patients kept out of trial created an obligation to approve L if all requirements and asks by regulators were met ie legit commercial scale manufacturing that can meet demand and successfully put together application. This is likely the explanation for the halt and subsequent silence due to an intervention into SOC enrollment that created lower powering of trial results. The first clean room expansion beyond Cognate, UCLA, Kings College and Fraunhofer was made after the halt. Fraunhofer also did a significant cell therapy expansion afterwards.
Maybe a little dilution doesn’t make that much difference for the average investor looking for a 10X return on investment in short order because this will end up being much, much more than that once treated as a tissue and then indication agnostic platform. Just because the only ones who know this are longs who are buying up all the new shares coming into the market and those few who want long shares sold cheap but are held out right now does not mean there is not major institutional pent up demand by those who know what the DCVax platform represents. Just because big pharmas are in no hurry to admit that they need NWBO and DCVax more than NWBO needs them while they make big money on their products does not mean they won’t make their move. You know this which is why you are here to save us… from the benefit of big returns on investment ; ). Best wishes.
Gus1212,
They did that with mice in preclinical trials. I don’t think they did that with dogs from what I read anyway. I think PETA would not be happy with that kind of animal testing and would have created a stir had they found out ; ). Best wishes.
Smitty5150,
Way back in the day this treatment was modified and used on dogs successfully in a vet hospital on other cancers and has been used in ovarian in a registered trial and other types of cancer in compassionate use. And you wonder if it works? Proteomics validates targets known to be common in other cancers and DCs illicit a combined immune response once it gets started. The science says it works and many patients are going to be asking for this to be made from whatever solid tumor they have. Regulators seem to understand this and so does NWBO. This is why the manufacturing update is so important and why many business only minded folks simply do not understand what it means. Big pharma CEOs are figuring it out quickly though. I expect some clearly defined and significant moves to establish positioning this year and probably sooner than most are thinking due to anticipation of manufacturing news. Best wishes.
exwannabe,
Forward looking statements and comments on Phase 1 data from back in the NWBO stayin alive desperation days?; ). There was plenty of time to try and bankrupt this company before and that didn’t work so time to make the switch must be coming soon. Thanks for the heads up!; ). Best wishes.
JRROBYN,
Talk to those in charge of “the process” that keeps a safe treatment from patients for more than a decade to protect the status quo. Big money greases lots of skids to keep the money coming. NWBO represents a change to that way of doing business as usual as they did all the leg work to bring this forward into a viable business model that can be replicated without big pharma taking it from them or their investors beforehand.
With all solid tumors, both resectable and un resectable being targeted and proteomics identifying viral and bacterial targets as well by this platform, the future seems limited only by the time it takes to build the infrastructure needed to treat all those who will be asking for it with NWBO currently the one to determine who is in and who is out. The status quo really isn’t too excited about that prospect. Best wishes.
StockFollower,
That’s the point at which Kat and Mr. Powers were treated and are alive yet today closing in on 10 years later. Best wishes.
learningcurve2020,
You need to stick to the script because that comment blows any credibility you ever hoped to have about the science to smithereens. By the way, the science eventually proves itself out as JAMA Oncology revealed. The sad part is that “the process” doesn’t speed up much for great science because of who it is really designed to protect which in this case very clearly is not the patients. Best wishes.
FeMike,
Cambridge will shout this to the world and the UK at least will respond. They made a big deal over Advent being built out and I guarantee you they will make a really big deal about approval and the fact that they are the only ones in the world with full access to this treatment that does not hurt but rather helps patients immune systems fight cancer. The fact that patients around the world will be treated with vaccines made there will also create a significant amount of attention and NWBO can actually tell their story. It really gets interesting if King Charles ends up connected to Advent and NWBO.
No need to worry about your price point. The US media is not the only place to get the word out and the spoofers will start getting some extra attention as well; ). Best wishes.
flipper44,
Yes I read that but years ago I read similar summations of how B-cells are activated and actually carry a library of peptide expressions which is linked to the hyper mutation stage I believe. If I recall correctly affinity is related to shape and polarization strength of any given peptide. Access to hidden targets is not often easily accessed in situ by DCs not properly activated by proper inflammatory signaling that draws the targets out into the open instead of staying hidden from DCs, T-cells and others. This is what NWBO understands so well and the situation Direct overcomes in the tumor microenvironment. Best wishes.
ilovetech,
Linda has connections to quite a few folks that know how to get things done. Mike Scott at Advent is just one. We are all obviously aware of Linda’s connections to the research community and that alone was a big eye opener during my early due diligence. The ability to get a Merck connection through Kevin Duffy is another. Don’t rule out connections to multiple others that might want to see the pie divided up with pieces going in different directions to create competition and discover greater efficiencies that leads to more rapid growth and expansion into future indications outside of cancer. I would suggest that some of the folks Linda knows are more than capable of finding all the resources needed including good partners. Best wishes.
flipper44,
The beauty of DC treatment is that they get B cells involved too with target specific peptides which leads to B memory cells eventually being created which allows for long term surveillance that helps prevent recurrence. Best wishes.
manibiotech,
Earlier FDA approval has not been my perspective but anticipated approval, likely with more closed system manufacturing approved has been. Like I have said earlier, this whole process could very well become a significant election year topic if MHRA beats FDA by a significant amount of time to approval because a U.S. company felt better about approaching MHRA for quicker approval than big pharma influenced FDA. Not a good look for FDA and those in charge of policy over the last 16 years especially after the Moon Shot program was put in place without supporting much earlier access by terminal stage patients to known safe treatments with signal of positive effect like L, Direct and some others. Best wishes.
manibiotech,
FDA submission and clinical trials will likely be timed up with finalized closed system manufacturing. This creates a seamless path forward to replicate and to promote to investors as the future path of cancer treatment. More importantly for patients is access and potential for interim reimbursement through the process Gary has shared about insurance companies sometimes providing reimbursement for experimental treatments, especially if approved elsewhere and requested by clinicians. Once NWBO provides proof of ability to expand access rapidly through franchise partnerships the load is off of them and is carried by those already able to do so. Best wishes.
skitahoe,
Viral vector activation of differentiated precursors which become harvested immature to mature dendritic cells depending on the type of treatment desired ; ). Best wishes.
RobotDroid,
Management already said where they would be and what they are doing now. You are the one stuck doing finger exercises for the message board posts accusing them of being missing in action; ). Best wishes.
Kap10jak,
One other consideration is that NWBO has both intradermal and intratumoral capabilities with DC treatment which when combined have been proven to be synergistic according to early research by Triozzi et al and that was research done with generically produced DCs with non optimized maturity and activation. What I believe this means is that in some cases maybe just L or Direct might be needed. In others a complete response with immune memory might be best achieved using both methods or a hybrid. I believe strongly that when it comes to proper administration of improved Direct that there will be no need in all or almost all cases for any additional components. Best wishes.
flipper44,
The true up lawsuit seeks to significantly reduce insider potential holdings. A decision against insiders could help weaken their leverage in negotiations and elsewhere. I don’t take anything going on for granted or as completely unrelated at this point. Best wishes.
dennisdave,
The interesting thing about all of this is the number of shareholders and shares owned that have been affected from not originally having a vote on true up vs those who have bought shares with access to full knowledge of the true up claim. Once the true up claim was in writing can anyone claim it is not relevant to their purchase of shares afterwards? Maybe only those who bought shares prior to the claim and still have those shares after the claim was made have true recourse. The true up claim has been widely discussed in the past on this board so it is not as if there has been no knowledge of it by those continuing to purchase shares and shareholder voting has not been hampered by unconverted warrants. Going to be interesting to see how this all plays out and how offers to NWBO of any sort will affect share price for all investors due to this situation.
The board of directors is not poor by any stretch of the imagination so if they suddenly buy shares on the open market to gain back whatever might be lost with regard to holdings gained by true up and before any knowledge of a final decision by MHRA then a clear signal will be sent that they intend to maintain control no matter what and there aren’t many investors or just traders that won’t act on that kind of news. I really don’t think there is any way to prevent them from buying back to the level they believed they had before any potential decision made to reduce their counts. Best wishes.
flipper44,
Not really disagreeing with what you are saying but rather pointing out that no outright sale of the company should be expected before 3 years unless market conditions create the price opportunity sooner than expected. I expect it will take at least 3 years for the true market potential to be realized and accepted so that current intrinsic and potential value is built into the price. A partnership or two along the way obviously gets it there faster. Very difficult for anyone to gain outright control from her ahead of time with the way Linda is playing this. Best wishes.
flipper44,
My bad. Not sure how I let that slip by. That post was meant to point to the manufacturing change needing to be approved at least one month before the end of a BLA approval process based on it not the end of the trial. Best wishes.
ilovetech,
No, not like what you are thinking. That will come much sooner starting with approval. What happens at about three years of manufacturing is a massive growth period and rapid rise in forward projected value. This is what institutional investment looks to be part of. Those who sell before this point miss out on a huge amount of potential value and is the very reason why we see all of these lowball prices flashing around on the board now before approval. Best wishes.
Chiugray,
Pure speculation but I believe some shorts are working to anchor the price to keep it low for at least one concerned big pharma that might be thinking their only chance to survive as a big is a hostile takeover attempt from retail. There are quite a few pharmas that could end up on the outside looking in and I think some know they are not welcome partners which means they might act accordingly. There are other explanations that make good sense about price manipulation but I still get the feeling that some of this has connections to a big pharma sensing their vulnerability. Covering billions in potential short losses for the chance to gain control before a potential loss of tens of billions of dollars in market cap could likely be determined to be a necessary risk if someone believed enough separation from their involvement had been created and that they actually had a chance to pull it off. Best wishes.
Single Stock,
I know you expect something sooner but I expect some really major news about 3 years from approval which is when I believe everything really kicks in. What could happen may happen sooner depending on how the market reacts to approval, understanding of combo patent leverage and initial rollout with closed system manufacturing with likely partnership news regarding combo trials. Best wishes.
FeMike,
I guess I could have structured that sentence better. The idea I was trying to convey was that the start to a move towards break even begins when that $30,000,000 overhead cost paid to Advent gets taken care of each year. Now as to whether or not 200 patients can get treated this year or not at Advent, maybe, maybe not but I believe they are ready and able to do this even with the other hurdles you mention non specifically. I believe Mike Scott is very well prepared. Best wishes.
manibiotech,
No spinning, that’s the job of others that you seem to have me confused with. Is closed system manufacturing fully approved yet?; ). I have consistently stated that I believed FDA would not receive anything until the closed system process is ready to go and that combos would likely be done with an approved therapy and product manufacturing process able to keep up with demand. FDA approval only needs to be expected by the end of the trial which is what MHRA approval portends. Best wishes.