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Whether or not a suit would be successful, I agree that this could be an area where management has invited risk which includes lawsuit. In my mind, that is why many companies prohibit conflicts of interest like this all together, even when they can be managed in an above the board fashion.
This risk and associated costs should be factored into the decision of whether or not shareholders of NWBO benefit financially from this arrangement with Advent. Sometimes the benefits of a suit are that they force transparency. I would not be surprised if this arrangement lands them in courts yet again, but I also would not be surprised to see the case dismissed or closed in management’s favor. To your point though, the appearance of potential concerns may put a drag on the stock price and cost the company resources in its defense.
In my ideal world, LP or any other insiders would have no interest in our partners business. Clearly the Cognate scenario negatively impacted the stock price and shareholder value even if the courts found no laws were broken. On the other hand, management didn’t have a whole lot of options available to them because of what happened to the stock price and shareholder value.
I still fall on the side of this being a largely non-issue, but you and Poorman helped me to understand that whether legal or not, the situation has risks that shouldn’t please shareholders. A lot, for me and how I finally judge management depends on the final outcome which is pending.
I don’t fault you for planning to cash in your chips at $5. While I believe the value of this IP could be as high as the lofty numbers people including me project, I do question whether or not this team has what it takes to get us there. Perhaps, the best scenario for you, me, and every other retail is a BO. Which is why I advocate for CRL to be that entity in a stock swap. Advent gives us leverage in that negotiation.
Poor man - these are good points and new ones as far as I can tell regarding this argument. I am interested in your analysis here.
It looks to me like the fees paid to Advent are actually quite small, but without knowing progress on other aspects of regulatory filings, I don’t have a good feel for the complete picture what other expenses have occurred over the past two years. Therefore, I question the size of “the investment in Advent” if any. They have not been working with a lot of money.
It seems to me that Advent is self-funded but benefits from a service contract with NWBO. This service contract to me appears to be below market rates actually for the past few years. Therefore, I expect there to be more significant gains in the future for Advent. What I am getting at, is it seems to me that this arrangement may have benefited me as a shareholder more than investment in a subsidiary would have, given the conditions at the time and the certainty of the future.
But I do value your knowledge here and am open to your thoughts
BTW Anders, I think it is just fine to raise doubts and criticism of management and be long the stock. I do that myself often. Some of the time, I am not even aligned to the criticism that I raise, but I am very interested in the response from the board. This board is amazingly educational. Even rarer, I raise what is criticism initially but when you follow the logic through to the end you may see that it is not negative at all but rather more evidence to the positive.
Which is why I ask where you are going with this line of questioning? How does it end for you? I almost always begin with the end in mind which I assume you do as well. What is the end result of this for you?
Both sides have spoken, the arguments are now circular. What is your play?
When it comes to Cognate, my opinion differs greatly on what transpired from what I see happening with regards to Advent. What I see happening in the industry all of the time is that companies frequently deal with uncertainty by outsourcing components of the business. If a company starts a new division but isn’t certain it will be a success or don’t think it will be a long term play, they often hire contract Sales and Medical Affairs for example. Even the big guys do this.
Right now and for the past several years, they have been starved for cash. Where the blame lies is irrelevant moving forward. Yet, they needed stable European manufacturing as well as leverage with CRL/Cognate and potential bidders. They could hire a company like Franhouffer or an Advent. So long as we are not overpaying for that service, I do not have a problem with the conflict of interest. I get it if transparency is your concern here regarding details of contracts, but I am not certain that I should be privy to all of those details. I also understand why LP would prefer to put additional investment into another business rather than give those profits to a thrid party entity. Again, so long as the fees paid are reasonable, I am okay with this. I assume that FH and Cognate at a minimum were used as reference. They may have even approached Merk…who knows. I don’t expect to know the details of an RFP. By cash burn rate over the past few years, at bird’s eye view, it looks to me like the Advent partnership has been far more economical than Cognate and reasonably low overall. I am not in finance, so this is not my area of expertise.
I do know that NWBO did not and could not at reasonable rates build enough capital to go it alone and hire the resources needed to get UK manufacturing off of the ground…not without severe dilution once again. So, I am ok with the route taken
Whitewater, There is no excuse not to have been ready for a Sept 3rd LBA deadline. If these folks don’t see the value in presenting data at congress, then their amateur status shines even more brightly and the proposed strategy to beat a drum of PRs is in question.
Every time I see you paint these charts, I get gitty when I see that they are LOGARITHMIC SCALE.
Look out for the next step….its a DOOOOOZY
Gus, thank you for your viewpoint on this question. It appears to me that you are well informed on this matter.
I believe it is okay to have a row with people and viewpoints that you generally align to and am not taking sides in the dispute between you and ATL. I appreciate both viewpoints and your willingness to share your knowledge and DD with others on this matter.
It doesn’t appear to me that you are making any accusations, and instead are questioning what has changed. If you get any answers, I would appreciate your sharing any new insights that you may impart.
Anders, I am trying to understand where you want to go with this, aka, what are your motivations?
The choices are basically make a fuss about nothing, stir the pot, whine and complain, or be patient.
Patience is the hardest of the four options.
Right now, we are heavy into make a fuss about nothing. From the sidelines, it is more entertaining than the typical stir the pot and complain. My heart knows, however, that patience is absolutely the only right answer. So I am enjoying the education about what has and what has not been made public regarding the terms of the contract manufacturing relationships.
Thanks for the informand the efforts, pgsd.
These sessions would be a nice follow up to a late breaker presentation on Friday. Fingers crossed.
I love the analogy Sojo!
The meal will be that much sweeter since we have been made to wait until we are famished. Things are smelling wonderful right now and I am salivating.
WW55 and Sojo, I am very much aligned with you both on timing. When LG appeared on the Big Bar show, he initially indicated that TLD release would be timed close to a conference presentation in addition to a publication. Later comments did not include the congress reference, but from what I recall it did not preclude a congress presentation. As many here know, I have long been a proponent of presenting the data first, followed closely by publication. Given the inherently risky nature of publication submissions and the possibility of needed to go to an alternative journal, I think it would be silly to leave all your eggs in the publication basket. The congress path is much more predictable, so you should pursue both.
When LL presented the External Control model in April, her presentation included the external validation against two failed and one positive trial. Shortly after she presented the SAP analysis plan for the primary and first secondary endpoints. She was signaling that all of the pieces were in place. To me this demonstrates that the stats had been run already or were at the very least ready to be performed. My gut says, she wouldn’t present work that was incomplete and that the draft publication was either written and submitted or in process to be submitted shortly thereafter, my gut also says it was already submitted by May 19th. To me that means the window of possible publication release is now open.
The time frames are all aligning around the October through November period. This is shaping up to be a wicked good end of year with news.
I never said that there isn’t a license holder, but you are wrong if you think that the license is not tied to the facility and the process. I have no idea who submitted the application for manufacturing license. If as you suggest, it is Advent that will hold the Swanton license, I think NWBO shareholders deserve an explanation of how that benefits us.
I am no expert here, but it seems this debate about manufacturing license despite being referenced by some materials is based on opinion at this point. I will weigh in with what little experience that I have to base my opinion on.
Long ago, I worked part time in a lab for a US-based generics manufacturer undergoing certification. My understanding is that the license covers both the site and the process. When the review is done the facilities are inspected as are all of the QA, QC, Validations, and Stability SOPs against the data produced for the certification batches run. Things looked at are stuff like ingredients storage procedures, actual human work flow, temperature stability for any in-process elements as well as storage locations throughout floor to ceiling, East to West, center to corner
The two are hand in hand, the facility and the process. The license can be managed by a new service provider when necessary so long as the same process is followed, tested and documented. IMO
I know of many people that get their information here at IHUB, some that came to our side from Twitter, Thanks to Danish Dude and all other flag bearers there, we saw from a post earlier this week that Discorders are lining up, I know my son follows another, we are shaping up for one hell of a retail revenge scenario when TLD lands from LG and LL.
Houston, can we begin the sequence?
Los Angeles? We are a go
London? All clear
Netherlands? Go
Maryland?
You know, BTW, that it is LL who receives acceptance from the journal. Not LP. She has to wait on LL and is a bit at her mercy
Thanks, hope4patients! Just how can someone with as impressive awards and accomplishments as Dr. Linda Liau get even more esteemed, she can oversee the acceptance of other programs as acceptably wise and skilled at removing and treating brain tumors to be allowed to teach others those miracle skills.
Uhm, hey shorty… she is literally the one representing my investment to 1) FDA, 2) a Journal editor (that risks their fellowship funding if they are petty) 3) her peers at some near term congresses, (who have awarded her nearly every high honor available to them) CMEs, other symposia, 4) to the public and investors in an upcoming Press Release by Northwest Biotherapeutics, 5) to Commercial Payers that may try to deny coverage for patients. Any guess about her sentiments on DCVAX-L for the treatment of GBM?
That is who I got in my corner? You have AF…he is responsible for what exactly? Represents who? Has been elected to what exactly? Awarded what top prizes?
Patience and confidence my long friends.
Patience and confidence
I completely concur with your sentiments ATL, and agree to disagree (but really only slightly, we are otherwise 99.5% aligned).
I too am 100% confident in my investment and agree that all or most all of those answers are ‘yes’ which can be supported logically by all the data and information LL has already shared.
I am just saying the decision tree for “no” in this case is way too complicated to graph because that is precisely how FDA works. Their answer to many questions is “that depends”. What happens with a “no”? That depends.
What happens when the original analysis of the first Alzheimer’s trial is a “no”, but the sub analysis leads you to revise the second study and thus get a “yes”? Well, that depends…
I believe that is why there in no “no,” not that she was telegraphing “yes”.
Unfortunately, ATL, I am as bullish as the next guy but I think you are slightly misinterpretating the meaning of that slide. She is not telegraphing outcome. Instead, my read is that she is describing the flow diagram for the SAP analysis. I interpret the lack of a ‘no’ path is because that answer is too complicated to graph.
I see the first set much like a sensitivity analysis where any one is proof of efficacy, but which and how many tells you how sensitive the measure is to various approaches. We know which one has the greatest strength because the second endpoint tells you. So how a ‘no’ will be handled depends on what picture gets painted by how many yes’s and which ones and by how big a margin.
When you are trail-blazing, FDA likes to see validation of endpoints.
Ike, I completely agree with you. The top priority should be regulatory approval followed closely by some form of scientific release of the data. It sounds like these are being treated as parallel paths and publication of data shouldn’t slow the reg process. TLD release to shareholders must accompany a scientific data release, but the primary focus is on sharing details with providers.
Time permitting I am suggesting that they look into activating the EAP at clinical trial sites, minimally. The effort isn’t small but would help to iron out many logistics at sites (saving and sending tissue for commercial purposes will come with institutional hurdles). This is a gesture that both the patient community and physicians appreciate despite it being limited in access to those that can afford any out of pocket costs that they pass on. It sets you up for immediate commercial access upon approval. By doing so you also create advocates for an FDA public comment session which applies significant pressure on the approval decision. Leave no stone unturned.
Thanks! Uhm, can someone remind me the last time LL spoke publicly and did not elaborate on important DCVAX information?
Ike, Are the not approved to run an Early Access Program in the US? I may be mistaken. That does require FDA approval BTW. It is treated similarly to a study but you can charge patients for cost of goods delivered. If my recollection is correct, patients never needed right to try legislation, they just needed action on an EAP.
If you are referring to legally defined harm, I would defer to your opinion. Certainly, pressure to move EAP forward with study sites does not seem to be happening and would not be expected before data release. CRL can provide all the drug cash paying US patients will need and the experience of running logistics and support would benefit all patients in the immediate post launch period. This two tiered system separates the middle class from the wealthy, however, which doesn’t sit too well for too long. I give them a pass on EAP until Oct 2020 plus a few months. After that, it is helpful to exert pressure.
Great perspective! Thanks, biosect et al.
There is no way IMO that the regulator you discuss would not require input before releasing the information that there is a 32 patient discord from proper randomization procedures favoring treatment. This information was not public before Mar 2017 and was preceded by FDA lifting the trial hold and company agreeing to end enrollment. This was not coincidental timing of events.
It also confirmed our theory and cannot be otherwise explained rationally by anyone here. Death by placebo must be removed from trial. Now how do you handle those placebos that have not yet progressed? Regulator? Are they still placebos because that’s not the intent of intent-to-treat?
AEK, Where did you find LL listed? I don’t see her in the preliminary program.
Iron Mike,
I completely understand your point of view about September 12th, in fact I think it is by far the most likely explanation about what she meant to say that date and in its presentation. I said a recorded message should be treated as a PR statement. I had a couple post removed this series of posts and I think it was becasue they indirectly had accusations made against management, so I’m not sure my entire sentiment still stands if you read back now, but some additional color would be helpful here
My premise is that everything on record that I read fits a story that I have about what has transpired except for Sept 12, although you also have to read a different meaning into PR and other statements after hindsight to see that. They are very craftily worded. That sept 12th is an anomaly which I have said many times before. I have also gone a step too far and have posts removed. So I wanted to go back and read again.
What I am saying here is that it is remotely plausible that she meant [to say] something .different….
So please stay tuned to [where to] see those trial results in just a few weeks. [how to], [when to]?
Flipper gave me this idea when he added dates in brackets to prior PRs. I believe she has a door, despite it being remotely plausible, to walk through that say something completely different. Because this was prerecorded that is even less solid ground to be on, but ground nonetheless.
I ultimately from my current read of materials and events believe that you do have to read the finer details of the PRs and statements to find carefully chosen words. That they always leave a door for an easy misinterpretation. That on September 12, they had little time to react for face value statements to be true because they hadn’t even locked [or at least posted us that they had] until October 5 2020. I believe there is a scenario and admit it is reaching to believe that allows this September 12 statement to be an unintended misinterpretation. I do not think it is solid ground. It was however corrected 3 weeks later and no harm done to shareholders as the details provided on Oct 5 were forward looking and corrected that timeline.
So I have been asking myself why? Why take that risk? Why do that?
They had completed a near miracle keeping the lights on and progress moving up to then and again thereafter. Even if you buy the theory that “it is all negative and they are stringing you out scammers” , why create that blunder and risk to your dangling at the edge thriller story that keeps some on pins and needles? Why do that?
To believe that piece to the story that I laid out in the last post is a big stretch. There must be a plausible explanation for why those words were said and how they were said on Sept 12, 2020. At face value they contridict a story and timeline that is otherwise quit plausible. I have some ideas to that answer and they are all good but my eyes are biased. So I am interested in other POV, as always.
LC2020, thank you for this article because it say as exactly the opposite thing your conclusions do.
It shows synthetic controls work and FDA is partnering with industry building new trials for labeling that include synthetic designs. This only supports DCVAX Phase 3 trial plan.
Thank you to Senti for the transcription, and to antihama for the reminder. It was color coded for me to make the whole thing very easy to digest once again.
For those of you who feel I am an apologist, you can stop reading and move on with your day. For some others, This is no fairy tale so please go read the Brothers Grim and go away. For the others, this is how I read the comments to be open ended all the way to today…
As reported July 2020, steps to lock and analyze and be ready to be consulting with its Principal Investigator and experts on the appropriate venue and manner of presenting the Trial results. This should happen by September 2020. To me this does not suggest release in 2020 at all. It suggests they will wait for the right congress or journal to release.
Thank you for the link. I will go back and listen but first I will read it. If there is no wiggle room, then It truly is an anomaly in my mind, but one that I trust hindsight may explain. At the time, I was quit upset and posted about it. I have since come to appreciate that they have always been careful to leave a door to open.
What you call “fairy tale”, I call a deliberate lack of specificity in the written record.
Thanks for the reminder, Senti!
I will have to think through the implications of pre-recording that message. Typically if industry prerecords anything, it will be the most conservative communication they do, no different than a PR really. All the more reason to comb through what she said exactly…Even if just to satisfy my curiosity now that I have hindsight on my side.
For those who do not consider me an apologist, I suggest you go back and reread the Feb 2017 PR with this understanding. Way back when I used the data from the two time point KMs to show that the OS endpoint trigger was likely not reached before Q3 2018. You may recall there are those that argued with me how to handle the LTFU population. I did not link but referred to the regs when I made my case versus the other side which was completely opinion based. With this in mind, you should see that the timeline from February brings us right up to the SAP development transition of Nov 2018. There was nothing fishy what so ever about that PR if you understand that they did not predict OS achievement well. They did not mislead anyone and they maintained the timing otherwise.
Now, they did insert the Oct 2020 process afterwards, but they did not spell out the timing of the last step anyway so I see that as granularity not deception.
Ike, I appreciate your perspective and comments today.
I think we get caught up in minutia on this board and frequently attribute our beliefs about what has been stated to be fact rather than opinion. I agree with everything you have said about management not only having the flexibility to update plans based on new information but also the responsibility to investors and patients to do just that if it is in our best interest to change plans. I honestly think you need to go way back to find anything to truly complain about other than September 12th, 2020. That one is an anomaly for me. I don’t discount that there was likely a purpose and that I may benefit from that purpose, I just cant buy that there was any validity to the idea of results had a chance of beying reported last September when on 9/12 the database wasn’t even locked. This is why I want to pick through the statements to see if any lightbulb will go off.
I don’t think that I ever indicated that legal accountability drove my comments.
First, I was not arguing with anyone when I asked for help so that I could reevaluate the statements made at ABTA last year. As ABTA is fast approaching, I would like to heighten my own sensors to the comments that may be made.
Second, the fact that an attorney is the party accountable to the statements means that legal liability is at the forefront of the minds that crafted the statement. Knowing this, I do think that it is prudent to carefully analyze everything stated before jumping to conclusions based on assumptions.
Thirdly, I contend that people here frequently confuse fact and assumption, including me. I also contend that one is accountable to their own assumptions, and I accept my responsibility in the decisions that I have made based on my assumptions. I am not happy about the timing or communication flow, but I have decided to stay the course. That is my decision and responsibility, not LPs. When on October 5th, the runway was changed, I understood this and decided to stay. I contend many others here made the same decision with a similar understanding. I do not think it is appropriate to blame others for a decision that I made almost one year ago after understanding that I may have just been misled a few weeks back.
This all started because I wanted to examine the ABTA statements closely to understand if I missed an important clue such as the clue I think that was left when a PR in August that included a year in every other date provided within but not in the forward looking date. I am saying that was likely a deliberate absence and something that I should have taken note of knowing what I know now. I want to have freshly prepared eyes and ears when I evaluate the next public statement.
None of this is an apology for LP or an indication of a desire to hold them legally accountable.
Then you are a name caller which despite becoming acceptable in our society, is none the less a childish debate tactic and unbecoming of your persona.
If the presentation was taped, did it have a dissolution date? If so, it is non-enduring. When was the presentation made publicly available and what was the timing in relationship to the corrected statement? The word enduring has meaning in this context. The stock price did not decline relative to the period before the statement or in the immediate aftermath of the correction which also has implications to the actions taken. In fact, the price has never returned to prestatement or precorrection lows. I am not sure that anyone can argue that they were harmed by the misstatement.
I have said many times that those statements were misleading. I am not changing that contention. I am saying that they have been carefully crafted and that one must read NWBO statements very carefully before jumping to conclusions. You may not like this about how they communicate. I certainly do not. However, I recognize my role in these conclusions. Buyer beware. Precise language matters, especially to an attorney.
Iron Mike, I am not defending the statements, simply pointing out that they are subject to interpretation and that that interpretation has been wrong. I am pointing out that LP provided herself sufficient cover.
A couple facts to consider….
While I have not researched this conference specifically, every other conference that I am aware of has a policy stating that participants cannot take photographs or record presentations.
LPs comments, while public, were verbal and not intended to be enduring. The above comment reassures presenters of this fact and depending on jurisdiction there may even be laws that provide reassurance.
Since they were verbal, misstatements are reasonable to expect and the October 5, 2020 PR corrects these misstatements.
There is a lot of tea leave reading that goes on here. I understand that we are put in a position to read and interpret breadcrumbs. I am pointing out, however, that tea leave reading is inherently flawed and that the interpreter plays a role in any misinterpretation.
Then I have to conclude that you do not understand my comments about how to interpret deliberately missing information. There is a huge chasm between walking a thirsty man to the side of river and actually spoon feeding water to that man. If an attorney stops on the shoreline and does not say go ahead an drink, it cannot be interpreted that that river has potable water which is safe for the thirsty man to drink. If they drink the water and get a parasitic infection, it was that man’s choice and not the attorney’s fault.
Flip, I do not wish to create confrontation with you, and I do not understand why you seem motivated to do so with me. My request for this information was genuine, I am not joking, and to have but withhold this information until a time suitable for you to leverage creates an adversarial relationship.
I have stated many times before, that I find LPs comments at ABTA last year to be troubling. I have justified this in my mind, but it is none the less troubling. As I am stating this morning, I have found sufficient wiggle room in every other statement that I am aware of, but those comments that I heard live at ABTA seemed quite definitive on timing. This statement does seem at second glance to paint her into a September 2020 corner, but I am not yet satisfied. I would like to reread the full context before making my own conclusion. The statement “expecting” provides some cover, and I can add a short phrase in brackets as you have done previously which would dramatically change the interpretation of this statement as it stands alone.
You just keep on proving my point which may not sit well with you, me or anyone else on the board.
Again, you added 2020 to a statement in which the year was clearly left out. If results are reported this month, that statement is accurate.
Exactly what I would like to reinterpret. Did she say September 2020 or did she refer only to September? Did you once again add 2020 when it was not specified?
I am not saying that I agree with the twisting of the English language. However, having argued exact verbiage with corporate attorney’s many times, I can tell you that when something is deliberately changed or left out, that has meaning and should not be overlooked.
Perfect example, Flip….You added the 2020, correct? The PR does not say that and while your assumption was reasonable at the time, it is none the less proven to be inaccurate. If results are released in September 2021, isn’t that PR still accurate?
Can someone repost the transcript from LPs presentation at ABTA last year?
I am curious to reinterpret her words given the current state of affairs and what has transpired over the past year. I have personally found that while statements the company has made had led me to inaccurately assume a timing for TLD release, when I go back and look more closely at the wording, I find the statements to be more loose than my initial comprehension. Example, FEB 2017 PR. While that PR definitely gave me the impression at that time that we could expect results within a year, it actually does not say that. In fact, the path that has transpired is congruent with the statements made in that PR.
So I am curious whether LPs statements on September 2020 were assumed by me to be definitive when they were actually open-ended.