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Evaluate,
Thanks for the post. Vaccination prior to DC treatment with tetanus or use of adenovirus is common knowledge now. Best wishes.
flipper44,
Totally in agreement but it also takes an environment, in this case 2 key opinions, to make this a reality. I see AVII77's view as one painted by the reality of the old guard revealed in discovery of recent bias and influence. This has been partially rooted out at FDA now. I see your view as prioritizing the influence on decisions by intent of guidelines and law. While the minimum scientific proof must be used as the basis for any decision, justifying the use of a minimum will always lead to controversy. This is why the 2 decision makers in this case had to be people with the fortitude to take the heat and AVII77 and I would both agree that this is rare. This decision is perhaps one of the first in a new wave of culture change at FDA. As you have pointed out, this should not be ignored either. Best wishes.
longx,
I agree with your sentiment completely. If you are on this board or any board long enough someone will challenge your motives. Sometimes that's a good thing because we all can and should be able to learn something new from varied perspectives either by those perspectives directly or by our responses to them that might require additional reflection and or research. Best wishes.
29YEARINVESTOR,
I wrote that Adam's last piece could be taken by some as a warning to shorts to cover and that now would be his silent period. No man's land is dangerous ground to be in especially if the other side is apparently planning a major offensive. The "Sea of Forgetfulness" is a great place to be in when a state of euphoria by new investors crowds out the voices of the long timers. Best wishes.
HappyLibrarian,
Surgery and recovery take time. The "independent" investigators will take the time to do the surgery right. Remember the old adage "buy when others are selling and sell when others are buying"? This is often counterintuitive to the level of distress caused by uncertainty which is why knowing the signs of change and why they occur is so important. There is an obvious reason why so many posters with large followings have suddenly come on the scene and volatility has increased. We are in the transition phase. Best wishes.
eagle8,
I don't know how the virus is used because I have not yet read the article but viruses can be used to prime the immune system before administration of DC treatment or can trick cancer into an immune activation call when placed in the tumor. Best wishes.
Rkmatters,
The reason we have probably hit bottom and are on the way up is we have hit or are very close to hitting a blinded data inflection point for the Phase 3 trial. This appears to be why the market makers have taken over. We are not completely out of the woods yet but Direct data points will begin to add value the longer we wait for L news. We also can not rule out monetization news for L if this was determined to be needed for the interim. The option for this would appear to be available now and the company hinted that ongoing operations would be the reason for compliance with the minimum price rule. SRPT decision in September. Agreement with Germany in September? Best wishes.
SteppenwolfSpeaks,
In order to fix what regulators "don't understand" first you need to understand the problem, then prove that it really is a problem and then suggest measures to fix it. Lax, non specific laws are essentially the problem. Abusers pay fines but are usually not criminally charged. Criminal intent that rises to more than a fine is difficult to prove in this environment. Putting together a case to prove one's innocence while at the same time proving criminal intent by others is very, very difficult. Obviously the MFN clause itself was not illegal but circumstances created the need for change and NWBO went above and beyond. Other compliance issues are also being worked on even with the obvious constraints of cash on hand and the conflict of competing interests for control of the business by Linda or others who would like to take it for themselves. You and others have benefited from this war but we are at the beginning of a new phase which marks the death blow or turning point towards victory for the company. Allan Butler is alive and the 6 year survivors at UCLA has dramatically increased since using DC therapy. Best wishes.
maverick_1,
Apart from these two, MD Anderson definately has some history that is not good though many researchers are top notch. It's those who like playing politics too much that get them into trouble. The best leaders know how to appease the special interests and researcher egos while still staying balanced in the best interest of patients and medical advances.
md1225,
I thought this stock had a chance to get to around $.25 before news but with the MFN change and traders coming in to declare a bottom near $.33 on volume, that looked like it might be it but thought there still might be some drift back down to just a little under their call because of financing issues. Turns out the market makers appeared to take over. I know Direct data points alone could help the share price but more than anything else, news that can be monetized is needed. This news is what any still short this stock and not covered by something to minimize risk are hoping will not be delivered. There are some big buyers who seem to think otherwise. Best wishes.
AVII77,
Cognate is still a separate entity which holds their own patents and creates the balance of power in the interim between now and warrant exercise. The increased value of NWBO shares with news and her ability to sell to friendlies for cash will allow her to keep control of the company as the warrants are purchased. Strategy matters. Best wishes.
marzan,
A post from last week, I believe, congratulated longs on their win. I thought this rather strange until your post here and that of another poster who indicated that news from regulators gets leaked out more readily than from big pharma. This post came about the time that Linda shuffled her speaking schedule. Do the pieces fit? Waiting to see. Best wishes.
HappyLibrarian,
Those who are in government are funded by those who already have the money not those who are looking for some. You have to wonder why all the so called philanthropists do not come to the rescue but with information they receive being filtered for them or choosing not to ruffle feathers I guess this is not that difficult to understand either.
Hope you are ready for the Allan Butler and friends data points being shared. Looks like some in the market are. Best wishes.
HappyLibrarian,
I know the intent of your comment about donating to cancer research was good but I found out the hard way that some cancer charities have not been very research oriented and this goes for at least one well known one. I stopped giving to that one. Another reason to support companies rather than just charities is that much research goes in the wrong direction as NWBO is hoping to prove. Best wishes.
sentiment stocks,
My understanding is that a while ago North Korea was counterfeiting US currency. We let them get away with it for a while but then our government got tired of it and changed the currency, put watermarks on it and took other anticounterfeiting measures as well. Perhaps there are similar measures being worked on today for another type of counterfeiting that regulators "don't understand". Best wishes.
sentiment stocks,
Exactly. I still think he had some of his own ideas though and those ideas may have led to a miscalculation. Time will tell. Best wishes.
maverick_1,
Just for clarification purposes, I am not a doctor or Phd. I have a degree in a multi science discipline, experience using toxic materials and I have pursued research in oncology related fields since about 1999. I have friends and family that have or have had various types of cancer. I found NWBO as a result of researching for an extended family member who had brain cancer. My back round has helped me with the ability to wade through the available research and recognize some of the less obvious connections as to how various pieces of the puzzle have been put together by NWBO and others. I was one of those annoying kids who always asks why and daydreamed easily. Best wishes.
Antti,
You can argue the timing of the land purchase but Mr. Woodford appears to have been on board with the preparations for meeting projected future demand. Part of any final comercial approval is proof of ability to meet projected demand. This process has been complicated by the nature of the manufacturing development changes with regard to automation which has been ongoing. Getting the cart before the horse may have been necessary even though painful for investors. This was most assurredly a calculated risk more than a foolish endeavor. Either way, time has proven your particular response was a good one for you and your style of investing. Any conclusions drawn with regard to this land purchase must also be weighed by the test of time to see how the strategy plays out since strategies can be affected by changing conditions. Best wishes.
sentiment stocks,
This is why Adam is silent with anything other than quick tweets. This is why the volatility indicates that major moves are being prepared for. This may also be why Linda needed to tweak her schedule. You have listed a number of the reasons why I have stated several times that there are about 7 arrows all pointed at one target and designed to hit at nearly the same time. There are results from other trials to be added into your stated mix of potential news as well and HE negotiated reimbursement may be dependent on Phase 3 trial news or at least an update of sorts on the lack thereof. My guess is that Linda's change in next week's speaking schedule is due to an important matter she and probably Les must be involved with right now and not because of bad news. Best wishes.
PoorMan-,
That "any day" notice may be why Linda delayed making her first presentation next week. Maybe she and Les need to focus on something else that is suddenly more important and needed to buy a little time. Best wishes.
Evaluate,
I stated almost from the start of my time on Seeking Alpha posts that my research led me to believe that NWBO had the best science to back their efforts as compared with rivals like CLDX, IMUC, STML and others and that they were on to a platform that could extend out well beyond cancer. That might be reason enough for secrecy and isolation all by itself. A little later I stated that mesenchymal genotype and phenotype, which occurs at progression even in non mesenchymal genotypes, was a critical part of understanding the correlation between effectiveness of the vaccine and the stratification of benefit in up to about 85% of patients based on the number of critical mesenchymal associated biomarkers found in each patient. This is why benefit will not be found in only mesenchymal genotype patients only but also in mesenchymal phenotype which most patient types morph into. Dr. Linda Liau has identified other treatments that might help unmethylated MGMT patients potentially find outcomes that rival some of those who have methylated MGMT. I am sure that she has freely shared this information with patients and doctors alike. As I became better informed about DC life cycle and subtypes, which play a critical role in understanding DCs beyond their APC role, I became more aware of the critual role that spacing of vaccines might play. flipper44 and I have had discussions about why crossover, low dose and increased dosing schedule should be helpful for this Phase 3 trial. Dr. Linda Liau's comments about all patients apparently living longer seem to confirm these thoughts when put in the context of trial expectations by a lead investigator. We won't know for sure that this is the case until enough information is shared but these comments were made within a specific research related context which create a certain level of added credibility value.
As I discussed with a doctor and their spouse tonight, sometimes the volume of general research remembered over the years helps me perceive things that specific research might confirm but does not necessarily make readily apparent in and of itself. Researchers often get bogged down in the specifics of actions and reactions and lose sight of the general context within which the specifics are enclosed. Those who step back from the table every once in a while seem to put observations into proper perspective a little better. Best wishes.
Evaluate,
Sorry, I lost track of the handle and remembered the other one first. Best wishes.
maverick_1,
Within that quote is the key to what my research led me to before Mr. Woodford bought in. It also is the reason for their desire to be isolated. Best wishes.
AVII77,
I think that was a challenge to EvaluatePharma not you but thanks for reposting your proof. I went to that site and checked out the larger mapped out area when you first posted it. That really is a prime time spot so thanks for that link again. Best wishes.
reg2015,
Allan Butler is alive and probably the lady with the lung cancer and perhaps the gentleman with the sarcoma that melted away through necrosis. Dr. Bosch may have something to say about that and Les and Linda might be working on some late breaking developments that they want to report on. September is generally a pretty busy month for news in the biotechs and bottled up news for over a year could make this September a month to remember for good reasons. Best wishes.
flipper44,
Hear hear Mr. Hemingway. Best wishes.
maverick_1,
Thanks for your take on this. I still lean a little more towards L or L+ (UCLA trial) partnership deals especially if Dr. Linda Liau is involved in the updates. There must be a ton of interest in Direct, though, so there is no way to rule out that strong possibility. Best wishes.
maverick_1,
I agree with your analysis unless institutions stay away too long and unexpected national or international news breaks that gives retail demand a chance to force the issue. There was already a high patient demand for the Phase 1 trial so imagine what a story like that of Allan Butler and perhaps others would do to Phase 2 patient demand for inclusion and investor demand for shares. I mostly expect the company to remain quiet about individual success stories but the shared data will obviously draw attention to them. The company and regulators need to consider very carefully the fastest possible route to determine success for Direct, get it to market and ascribe full benefit. Patient demand could easily overwhelm them all if they don't. An HE type program for Direct could be quietly being put mostly into place now. Much of the Direct treatment process is duplicated from L except administration of treatment and that training could potentially be given along side of the training for L. I imagine updates and an SPA for Direct might be in the works and that would be rather surprising news. Big pharma agreements would be great too. Best wishes.
As long as the share price is low enough when news hits, retail will want a piece of history and it won't take long for them to respond to cancer being defeated by a treatment with almost no side effects. Since NWBO is no longer in major index funds, it can for the most part take all the attention for itself.
BuyWhenISell,
I agree. Those transactions should be recorded but obviously naked shorts are not being given much attention. If the numbers of naked short shares are as high as stated might be out there, where are the demands for proof of ability to cover. The problem is nobody really cares until a demand comes in to actually cover but if the investigation concludes that the demand can never be met legally then all kinds of folks will have their toes held to the fire. This may include criminal charges of neglect or worse and most certainly civil court liability. If the case is shown to be bigger than just NWBO there will be impetus for governing laws to be changed. There are reasons to believe that this is the case. Best wishes.
BuyWhenISell,
In order to present a case with teeth Coffer Black needs to unravel a very complicated set of trades which were probably executed in milliseconds and trace them back to the perps. He needs to prove that the shares could not find a way to be covered and would want to determine if deliberate malfeasance by a group can be linked directly instead of indirectly to the actions taken. This is the difference between a slap on the wrist and criminal charges. This investigation will be thorough, very thorough. Best wishes.
shirley23,
Thank you for posting here. A message board like this one can look more like the House of Commons or the House of Representatives discussing funding issues that divide along party lines than a support group but believe you me there is unity to be found around finding a cure for cancer and supporting those who are suffering from it. We may not agree about who is headed in the right direction with research but most if not all would agree that you and your Dad deserve our encouragement, prayers and best wishes.
Rkmatters,
I hope it's Lost Boys that page is from and not Deep Capture. LOL. Best wishes.
TiltMyBrain,
You know that when people like Lazarus and Allan Butler walk away from the grave for a while there are going to be some followers of those who helped them do that especially when some have tried to bury the helpers as well but just couldn't get the job done. Best wishes.
Smokey21,
I'm not sure of the process used after surgery only that he had surgery and that one patient in all of the Phase 1 patients had prior immunotherapy which, from what I read, was him. Best wishes
longfellow95,
The cost of doing business is going to be much more than they thought. First they can play with the legit shares in margin accounts and their own leveraged holdings. They need to do this before the wider market is made aware or they lose all control as has been alluded to. Best wishes.
rancher64,
The combo patent between checkpoint inhibitors and DC treatment alone will make it worth that much and more in future earnings. Add to this the fact that L and Direct can be used as their own combo with no quality of life issues and well... For those who care to do a little look see please check out Allan Butler from Nat Geo TV. He has been a VP since 2013 to present (3 years and 9 months). He was diagnosed, according to his own testimony on a Stand Up 2 Cancer video, with stage 4 pancreatic cancer and was out of options back in 2013. He was given both DCVax-L and DCVax-Direct and is the only patient I know of who has received both. Direct is known to cause necrosis which is a type of cell death caused by lack of oxygen and nutrients. Allan had enough change in his tumor that it became operable and as you will note from checking this all out, he is still working at Nat Geo. Best wishes.
reg2015,
Sorry I have not kept up on the other board for a while. Glad to see you here. Best wishes.
Smokey21,
The only reasons that quickly come to mind are taking profits against other losses if they convert to shares and then sell or converting to shares for voting rights if those rights become important enough. Best wishes.
PAC,
If you look at all the signs, you will see the pattern of buying here suggests strong interest by those who know the game. Strong volume on setting a bottom and strong volume into conference time based on cash from warrant reprice with share purchase to net NWBO the last bit needed until then. Less than $1,000,000 net. I guess the signs say "Going Out Of Business" on one side and "Short" on the other. No wonder there is so much confusion. Let's see if they are resetting only part of their position or someone creates a stampede. Many millions of legit shorts can now be covered by the low priced options and warrants. Anything else could create the stampede. That kind of stampede could lead to turning on some big pharmas by shorting them in anticipation of future consolidation and need for cash now. Looking forward to seeing how it all plays out. Best wishes.
pgsd,
In other comments they also suggested they would be increasing the number of treatments (duration related?), number of tumors injected (neo antigen and cytokine level related) and decreasing the interval to about 2 weeks (perhaps immunosupression related due to natural cycling of DCs out of the tumor environment). Best wishes.