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flipper44,
Your comparison helps to demonstrate accurately the position NWBO is in with a scenario that alligns accurately with clinical trial process and a point between the historical PFS you used, which represents a historical absolute best case scenario for bears, and Dr. Linda Liau's comment of about 24 mo OS. Better results would stretch the OS or PFS point out further which is why the stock price bottom needed to come later summer to early Fall before analysts start jumping in with more positive predictions again. This is also why Adam most likely chose August, prior to the raise announcement, to warn/scare. Best wishes.
chinatown1980,
You are skeptical but that is hardly foolish in this situation. As for the selling, I'll leave that for someone else to do because I am in for the long haul. We all have different situations and perspectives which is why there are different tolerances being expressed here.
I have a long memory and I watched for a while before I ever bought any NWBO. The similarities and differences to the DNDN situation stood out clearly to me very early. One thing stood out above many others. DNDN had well over $500,000,000 on the books when I saw their need to make a radical change in their structure and focus. They did not make the changes necessary to become profitable and their debt consumed them. I saw that Linda knew how to keep the boat afloat by shutting down and drifting for a while to where they could get back on track. She has also found a way to stay away from debt except to herself which has kept outside creditors from gaining control of NWBO's future. She stayed disciplined and moved only at the pace the company could afford to go until help came and she structured her companies so that she could maintain control when she knew heavier dilution would be necessary. She has throttled way back again while we all wait. Best wishes.
HappyLibrarian,
How did "Rocky" end? I've seen some about to go bankrupt and bounce back. TPIV was on my watch list before Rkmatters, Pyrrhonian and others were looking at it and it has had a rocky road. I like Mayo Clinic and their tech looks interesting but I never saw the potential as being on the same level as here which is why I was watching only. There are others which Adam consistently picked on for good reason which just wouldn't die. My own research led me to believe that one in particular was a total scam apart from what Adam had mentioned which turned out to be good enough on its own. The bottom line is that I have seen companies in worse financial shape than this get financing and Linda knows how to live on a shoestring, especially one made of leather. Best wishes.
PoorMan,
I think that the relationship between Mr. Woodford and NWBO has a chance to be worked out but much depends on the independent investigation. Hopefully Mr. Woodford was only drawn into the current situation by those who sought to sow seeds of distrust as some respected posters here suggest and NWBO comes out clean. My read on Mr. Woodford has been different than theirs based only on the actions taken by both parties and timing of events. Still, the company appears ready to be able to take on some additional buying now and still keep Linda in control. The buying won't matter whether from Mr. Woodford or not and Maverick has shown us how that might play out. Best wishes.
austinmediainc,
I understand your angst and total frustration with where the share price is at here and the reasons why. Still, you have seen my posts on SA and here and you know that from just about the very beginning of my posting history on SA and more recently here, I have warned to watch for DNDN like manipulation and price movement. I have also made clear that I am in this investment for the duration. Besides this, I more recently warned to be ready for any scorched earth type of price movement and Turtle shared the same sentiment early and often in the current down trend. Maverick posted his move and sentiment perhaps the earliest of all current and active posters here. The company silence which can be viewed as fueling this downtrend has been most assuredly brought on by being told to be quiet and or a desire to release only unimpeachable news. What they could have done differently depends greatly on how they have been counseled and the strategy they chose because of it.
Now, let me address the core statement in your post which is "And you are a much smarter investor and person to honestly believe anything is any different then (sic) it has been over the last 5 years". What I honestly believe is that 5 years ago this company had little hope of finishing this trial in this century but had some promising early data. Today this same trial has had more than 300 patients enrolled for more than one year and about 200 patients for about 2 years or more. That means that a dud readout would definately be expected soon even if interims were not reported which is what Pyrrhonian has stated. The dilema lies in the fact that any more passage of time starts to favor DCVax benefit. In the last 5 years we have seen patent approvals, DCVax-Direct trial start and UCLA staff sharing their takes on video with us. We have seen new manufacturing expansion and agreements put in place and receipt of PIM, HE and other important designations which may still play a significant part in DCVax development depending on the timing of critical elements of the approval process. How the company responds may not have changed much in the last 5 years and talk is cheap but trial maturity and commercial readiness has changed and isn't cheap. Best wishes.
flipper44,
If things are patched up Mr. Woodford will make sure there is solid price support at all the right moments this time around. Best wishes.
2014turnaround,
Clay is here and Adam going quiet. Isn't that like knowing what "that" means×2? Best wishes.
flipper44,
I think the other responses have summed up the situation pretty well. What I like now is how Pyrrhonian's analysis and Adam's last article on NWBO pointed to the same timeframe. I suspect his article was meant to warn shorts that the risk/reward profile is about to change and so he will disappear into the Sea of Forgetfulness for a while. With this in mind, I suspect a number of shorts read his comments the same way and were ready to buy the tradable shares added into the mix recently to cover some of their positions. NWBO and September have a fairly memorable history together. Best wishes.
austinmediainc,
You are a much better investor than that unless the house you are putting up on no "news in September" is a Lincoln Log cabin you may have played with as a kid. Best wishes.
TC Trader,
Once you have been through a few storms in life where the boat seems to be sinking (like NWBO's now) and Jesus is still asleep in the boat, you learn to let him sleep until he wakes up on his own. It's that "peace that passes understanding" thing for me. Best wishes.
HappyLibrarian,
There are accounts in the Antiquities that if taught in public schools would bring a whole new level of understanding to world history. One such example is the arrival of Alexander the Great and his army at Jerusalem. Put that encounter in context with the rest of what is written by him and you will understand how history is often rewritten or screened to conform to a certain agenda. Kind of like how certain journalists have written the history of NWBO in a certain shadowy light. Best wishes.
chinatown1980,
I reiterate that we are at the crossroads of failure or benefit very soon. Pyrrhonian has suggested this, Adam has said he will now not write anymore articles about NWBO and I hinted months ago that he would work on NWBO only until August. The raise today was only to get them into September without a reverse split. Linda has 2 conferences scheduled for September. Who do you think bought the 3,000,000 shares today? Why all the confluence of events? Best wishes.
vator,
There is a time and a season for everything under the sun. Right now is the season to get the DCVax -L announcement ducks lined up in a row and this does not mean an end to the trial unless PFS and OS benefit are fully established, which is doubtful, or for OS, if PFS is established, at least given the chance to fully mature and count towards credited benefit by regulators. Then I expect we will hear about the investigations. After that we will have Direct updates.
What we have just witnessed today is the cumulative effects of a scorched earth policy by manipulators coupled with delayed eventing causing poor financing options which leads to the death spiral commonly mentioned on this board. The company is most assuredly documenting this entire process along the way. I assume they will have adequate evidence and help from their board of directors to demonstrate how this works and perhaps present this in court and or to Congress for some sort of future action if my read on their moves is correct.
What is interesting about all of this is that Adam said his recent writeup about NWBO would be his last one period and I expect that means until definitive news. Do you want to venture a guess as to why? I previously wrote a comment to him indicating that his attacks would probably end in August. Pyrrhonian also indicated that we should have news about eventing soon based on failure. So guess what happens if there is no failure news soon? Correct, the tide begins to turn. This is why Adam will now be silent and wait as the rest of us must do because as we have heard before, there is lots of money on the line let alone a chance for better quality of life and outcomes for cancer patients. Best wishes.
HappyLibrarian,
They are obviously trying to hobble into September and that is about it. Now why would that be? Best wishes.
slappdaddy,
Blood cancer not solid tumors. Big difference. Best wishes.
HappyLibrarian,
Maybe not so heavy but definately laborious and filled with interesting tidbits of relatively unknown history are the works of Josephus. Best wishes.
chinatown1980,
I agree 100% with your statement "They have run this ship straight into a rocky shore." Putting a stop to trading the shares, though, would put too much additional hardship on investors. I assume the investigation might lead to some recourse for those who have lost money due to manipulation for whatever reason so better to let the shares trade for liquidity purposes and settle up later. Where we are now is in the scorched earth category that I mentioned before was possible and to be prepared for. As I mentioned to Pyrrhonian we are at a crossroads where the potential for failure and success are about even with blinded numbers but soon the numbers will start to favor success by any known standard and he is fully aware of this. Many are not. Best wishes.
chinatown1980,
The main issue is no one knows the timing so getting in at the right time as Mr. Woodford tried to do can haunt you if you don't have the patience or wherewithall. Best wishes.
chinatown1980,
Maybe this is partly why the investigation is taking so long? There is a reason why a big fish gets to be a big fish. Once you learn those reasons you have a chance to catch yourself a trophy. Best wishes.
chinatown1980,
I get it. Really I do. Believe it or not, I have seen what my Dad went through with a struggling business and though he was more open about the company situation, the situation itself was much different. With NWBO we are looking at a situation where a company either has a cutting edge technology or a flop. My Dad's situation was with a company that saw definate cycles and knowing how to get through them with business moves that could handle the ebb and flow was critical. He had to find the best financing availabke at times and he worked tirelessly to that end but did not have the kind of very real public opposition to his business that faces NWBO. He kept jobs in a small community and saw the company survive and prosper because of answered prayer and because he was a disciplined leader of that company. Linda Powers has far fewer employees than my Dad had but the product itself has the potential to be far more wide reaching. Linda's energy and that of those around her must be completely focused on the most critical tasks at hand. If answering publicly to investors becomes a distraction to what is most needed because answering leads to more questions or because she has been advised not to answer to help prevent further litigation attempts, then she needs to do this for all of us. Whether or not we see, from our perspective, that this is helpful or not becomes irrelevant to the goal which is a positive final outcome. The unfortunate but not unexpected outcome from this is degraded investment sentiment over time which you and all of us have expressed at one time or another to some degree. Opportunity loss is measurable and a very real criteria for an investment decision but so is a decision to support a company in the face of it so that a company can get better terms than if that support were not there. I saw that with my Dad's situation and I choose to consider the latter more important than the former with regard to my investment here. Best wishes.
vator,
I agree with your sentiment but think there is an outside chance that state courts could cause some real pain for manipulators and perhaps there will be enough evidence of abuse to get laws changed. I hope they are tightened up so that the pain becomes personal and criminal in the future. Best wishes.
exwannabe,
What are the Opdivo side effects compared to the placebo like side effects of DCVax-L? Correct me if I am wrong but the safety profile has already been establised in other indications for DCVax-L in clinical trials. These might be reasonable considerations with regard to Linda's statement yet you completely dismiss this without a mention. If the only question is how well a treatment works, a trial can confirm this while a treatment is already in use for the indication correct? Best wishes.
md1225,
So true and the who has what and how much on who will play a nearly unfathomable part of the behind the scenes jockeying for position. Call them the lawyer games. Best wishes.
chinatown1980,
I appreciate your clarification in response to my post. It expresses your legitimate concerns as an investor with the current situation NWBO finds itself in without the potential interpretation of malevolent tone attached. I appologize if I misinterpretted the sentiment expressed in first post. Best wishes.
kabunushi,
Actually, Linda commented that a new trial for each new indication for L would not be needed. Rather, a simpler application for a label extension is all that is needed. This is one of the underappreciated reasons why market cap could support much higher levels than some would suggest if approval is granted sooner rather than later. The HE program has already essentially granted a label extension for that program by expanding the patient population to all glioma and astrocytoma patients besides just GBM. Also a quick move to make DCVax-L part of SOC based on solid results would be expected due to its safety profile. Best wishes.
chinatown1980,
If "Linda is the wicked witch" is the only argument you have left you are in bad shape. Cognate and NWBO are worth much more to Linda if both are alive and well instead of only one. You and many others have poured cold water on Linda many times and she isn't melting but she sure is mad. The longer the silence from her goes on, the more likely those grapes of wrath she has been storing up will be tread on for every last drop of justice to be found for her and all of her companies including NWBO. Best wishes.
Truthfan,
Now why would Robert Margolin from Cognate be spending so much time analyzing clinical,regulatory, merger/aquisition and partnership activity? You would think he would be busy working on his own situation with NWBO what with the investigation and all. Seems he has been tasked with preparing for some big plans and this is part of the comparative analysis Cognate and NWBO will use in the not too distant future. Maybe like in ongoing negotiations with big pharma? Best wishes.
exwannabe,
That is what Pyrrhonian has implied is the right of the company, that is what Rkmatters indicated the protocols referred to and that is basically what Linda Powers said when she said she would not end the trial early. With benefit seen by DMC, the determination of the true median OS is the pot of gold for the company that sits at the end of the rainbow. The problem is they might not know exactly when they get there though they should have a pretty good idea by now. The question that remains is whether or not improved outcomes have occurred due to any approved changes in the trial which is the wild card and if the pseudo trial patients are added in before the end of the trial to get everything included on one label in intent to treat patient population. This could cause additional OS determination delay. Best wishes.
Pyrrhonian,
I like your response to Longfellow but would ask you 2 things. You made the point about the screening stop more about leukopheresis issues than what the stop inferred was happening which is new screening hold. Those who were already started in the screening process apparently continued on with that process including the leukopheresis. So unless we have absolute clarification about this I am assuming leukopheresis did continue to happen for those who had begun the screening process. This would be contradictory to your assumption of the need to prevent an unwarranted risk being taken. This then points to benefit differences being realized where the real risk is SOC vs treatment but the blind must be maintained so those already in process continue so as not to inadvertently break the blind.
The second point is based on your assumption that Linda Powers would immediately publish a DMC recommendation for a halt for efficacy. I would strongly oppose her doing anything of the sort until full PFS and MOS are completely established. They have suffered far too much and too long from others to leave anything on the table. They certainly don't want give any wannabes any easy chance to catch up or pass them. This might be consistent with the reported conversations with Les recently about 10s of billions of dollars being at stake. I think you understand this and your assumption that the treatment is a failure based on your numbers needs to be addressed by an announcement pretty soon or your goose is cooked so to speak. We are definately at a tipping point but thanks to your charts and big pharma's conclusions about the potentiation of checkpoint inhibitors by DC therapies, I think longs are in the drivers seat within a month without news. Within 2 months I believe your public position will probably change again without news. Best wishes.
exwannabe,
Yes, putting patients into SOC in a trial where regulators have peaked and confirmed statistically significant benefit of treatment over SOC (theorhetically) would be unethical when the FDA can not stop the trial because maximum PFS or OS endpoints have not yet been reached. Regulators can not force the trial to end and deny full proven treatment benefit. Best wishes.
foxhound02,
Just as a follow up thought. I am not sure how or when the pseudo trial results might be added in to the main arm results but as a guess, there might be an outside chance that if the DMC recommended a halt for efficacy that NWBO refused but then petitioned for the pseudo arm to be considered for addition into the main arm results to find final unified intent to treat cohort MOS and PFS. This might explain the screening characteristics information mention and length of delay. This does not explain the expected one month enrollment delay mentioned unless this short delay was expected to be a worst case "No" response indicating too early or neutral results at best. I am guessing a "yes" would probably not be discussed during a wait for results. Best wishes.
foxhound02,
Enrollment criteria may well be one aspect of the overall picture. UCLA announced they had a way to correlate benefit to markers so that could be part of what is being looked at even if it is not the main reason for the continued hold. Seeking to determine the final median OS without subjecting patients to lesser treatment options based on a very strong (perhaps even statistically significant as perhaps seen by DMC and FDA) but not finally determined OS may be the "It's NWBO's call to end the trial per DMC recommendation and unblind the trial but they can't add new patients to control" reason for an FDA hold. FDA can not force the trial to be unblinded if trial endpoints are being exceeded and are not yet reached. The company has the right to determine final PFS and OS benefit if this is the case. If the company chooses to determine this by waiting until the median has been reached or the last patient has crossed over then this is their right. Best wishes.
flipper44,
(With heavy German accent)"Interesting.. very interesting." Now where have I heard that before?:)
Pyrrhonian,
Thanks for tuning in on this. Best wishes.
Rkmatters,
Correct me if I am wrong but wouldn't an early trial stop prevent NWBO from collecting full value on any approval OS benefit claim? I ask this with regard to future combination treatments value claims or for other treatments to attempt equivalency or superiority. I appreciate your effort to look at the "good news might be temporary bad news for investors" angle because it should be considered but I just lean in a different direction. If FDA really means that NWBO could talk about something but they aren't because they said they would take this trial to completion even with a DMC recommendation to halt, then this wait for absolute OS benefit might be why. Remember Temodar?
iclight,
The problem with your last comment is the word "potential". Regulators must have proof before they can treat "potential" patients. Only statistical significance is proof. If this can be achieved in about the same amount of time as a continuation of the screening would provide without enrolling new patients into an inferior outcome arm of the trial then an ethicist would recommend doing this. All of us would like good treatments to move straight to Go and collect $200 but that is not the way this monopoly works since it is set up more to weed out bad treatments than to rapidly advance good ones. This rigidity prevents what you suggest from happening as an unfortunate consequence. Best wishes.
A strong trend with wide separation of OS benefit but slow eventing because of better overall OS from cross over could cause an ethicist intervention. There is no SPA for PFS so taking this trial to well advanced maturity or full secondary endpoint measures is important and is consistent with NWBO comments. If FDA was alerted to this potential, they looked at data and then found this to be the case, then they would not want to randomize additional patients into SOC. To stop randomization without destroying trial integrity the point of stoppage would then need to be at new screening since once screening begins patients must be given the chance to enter the trial. Best wishes.
austinmediainc,
If PFS is solid and OS separation is trending good but not there yet, FDA could say no more screening for ethical reasons. This hasn'T happened before with this kind of immunotherapy and if eventing is slow.. well you get the point. Best wishes.
austinmediainc,
If PFS is solid and OS separation is trending good but not there yet, FDA could say no more screening for ethical reasons. This hasn'T happened before with this kind of immunotherapy and if eventing is slow.. well you get the point. Best wishes.
DoGood DoWell,
If you go back and look at those charts with regard to patients treated by UCLA you will notice an overall increase in 6+ year survival in multiple age groups. I would venture to say that their 6+year survival rate is curiously and significantly above historical norms for most of the various groups. Coincidence? I think not. Best wishes.