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I want to go to bed, but I appreciate the offer. I will end with this, the problem with your last statement is that,
A presentation at a conference
I did not say fraud Biosect, I said fraud or incompetence.
Because you do not have an approved label to market your drug in the United States of America, does not mean that you are not governed by the same regulations that apply to one who is marketing an approved drug. To do otherwise creates unnecessary risk to the process itself. The impact and implications of false advertising are broad and multi-faceted. I do not wish to print one of those implications because I do not wish to alert anyone to it.
Connecting ideas in space and time connects those ideas.
Because I debate from the other side of a die that has several sides, does not mean that I believe that. I presented a case with passion and even some anger. For that case to come to fruition, LP is either a fraud or incompetent. I don’t believe either is true.
I believe we will get and answer tomorrow, but I no longer have faith in my ability to read this case.
I believe that the case is a clear one, however, and one that I have not fully revealed which is why I do not believe LP passes SNO bye without some meaningful news. She is an attorney after all and should know when to seek legal advice from someone with the appropriate specialization.
Why? Because it is reasonable to believe that they needed a forum like a publication or SNO to break news that DCVAX is not fully safe or effective for the treatment of GBM, but at this point or more precisely by the time we reached the LBA deadline it is no longer reasonable. At that point they must correct an overstatement of efficacy claim to me at the earliest available opportunity.
I guess if everything is great you could continue to wait for some odd reason, but why would you? You cannot wait any longer for a misinformed claim of efficacy, however. You must correct that promptly and adequately, which is my well-informed opinion.
Iron Mike - I love your alias…oops I went back to read what you replied to and then replied to the wrong post
Iron Mike - I love your alias
Thank you, Senti.
I will probably go back to an oldie but a goodie with a glass of wine
I will sleep very anxious tonight as I await news or lack there of tomorrow.
As you review, please bare in mind that 5 patients told their story of a cure which was attributed to DCVax after everything Marnix had to say outside the scientific session where they have safe harbor and inside the exhibit hall where to present information is to do so to customers and/or patients and can only be done after paying a fee. Entrance to an exhibit hall may require a badge but it does not require you to be a health care practitioner, and none of this was required to view the talk then or now.
So I have an expectation and it was set by them and does have a timer associated whether or not you agree that LG set one or that the SEC can and will enforce one. Of this I have believed deeply since May of 2019 but may not have clearly shared this on this board in the past, but I left breadcrumbs…pun intended.
I have been quite patient.
Good night, peace and love to you and all with good intent
Biosect, I have not read any other replies yet and will but may not reply. I had no intentions of doing so, but my best friend is upset with me, not you Biosect. I appreciate your viewpoint and the viewpoint of many others here and have appreciated contributions of both longside and shortside commentators. I believe this to be not only a place to find great knowledge and insight alongside trash, but also a place to debate under alias and the advantage that brings as well as a source of communication directly to and from the company.
I invested here and stay invested here because I absolutely believe in the science and in LL. I understand also that things may be going on that I do not know and do not understand…and that is one piece of my issue.
I may not understand every aspect of regulations, rules and laws and I am not an attorney. I am not threatening anything at this time. But here is what I do understand about those things… some things are written in pencil and can be erased, other things are written in indelible ink and cannot be erased, smudged, or ever struck from the record. They must be corrected if wrong and they must be corrected in a timely fashion. You know this too whether or not you will agree with my next comment which is a very, very big issue for me and was raised by me here in May of 2019 if I recall the date correctly. I will also remind the readers that I am the one who broke news of the 32 unrandomized patients here, because I already knew this was the case and looked for confirmation immediately upon publication.
DCVax-L is both safe and effective for the treatment of GBM and I know this statement to be true because the company has already told me so in paid advertisement although I am reasonably confident that most people here do not realize this or may not accept this statement. It has not been corrected in a timely fashion.
So yes, I am sick of waiting for them to make this clear to everyone and my patience has worn out. While you or other people may see this as just another stock and trade in and out, and others may see this as an investment which will surely pay big dividends, I see this as a life saving treatment that is not coming to market quick enough and I own a piece of this company, ownership is how I see it which is also an investment but a much deeper commitment than just that.
In a shadowy way, I will also clarify for my friend my comments, lack of comments, sidebar distraction or whatever else you may call it.
Someone who is an NCAA star basketball player may appreciate in a different and deeper way the college football game they are spectating, and may even be quite good at backyard football with their friends. But they do not understand the real show they are participating in as they cheer along. They do not know what it takes to plan, prepare and execute a championship victory in football and put it on live TV, nor do I despite playing fantasy football for over 20 years. Football has not been my passion that I found when I was 19 years old and attended a New Drug Science class as an undergraduate. As anyone who loves something deeply, I will passionately defend and judge others partaking in my passion as well.
I have more to say but will stop there.
People that correct spelling errors of others are ignorant to disability and could be correcting a learning disability that is Federally recognized.
I suggest that people should no longer be ignorant and learn these things, especially when you read my posts. I do my best but this environment does not warrant the attention necessary to overcome this.
Make note of this please as it is okay to do so here, but please do not do that in the workplace as that individual is Federally protected but may not come forward for fear of prejudice and retaliation which is common practice in the workplace for those “protected” by the law.
You know that you can be incarcerated and forced to take the treatment, if you have TB and refuse treatment in the US. It is not lawful to expose other Americans to the risk and risk reintroducing the mutated strain to the vaccinated world. If your irrational medical decision puts others in harms way, the government has the right to force you into submission.
Just saying…
COVID keeps mutating and eventually will overcome vaccine protection for all of us if left to circulate at these levels.
Polio was a live virus vaccine that caused polio in some patients that took it, but there is no more polio because people used to care about others as well as themselves, no mandate required.
Add all of the US deaths due to any vaccine, not just COVID, and all of the vaccinated deaths together and you may reach a number that is about >0.1% of the COVID related fatalities.
I have a friend whereby he and his wife got COVID on St. Patrick’s day. They has a seemingly benign course and walked away feeling invincible to COVID. Now the wife has long COVID as her immune system attacks her lungs 7 months later. They are currently not very successful in controlling these attacks and she goes into respiratory distress regularly.
But go ahead and fear the vaccine that has been given now over 1.4 BILLION times to humans with a dozen or so reports of paricarditis (a known and common COVID complication).
That is a rational fear…keep telling your self that just as someone else we know keeps telling himself that he is still the leader of the free world. He never was, the free world turned their back on us because of him. And anti-vax fears are his fault.
Let me provide a solution to this dilemma and situation. Essentially, what you and others say is that we need a top journal publication for validation with the investment community. I do not think anyone in medicine will question the results put forth by roughly 70 of their top experts with any sincerely, and they will not care if it is NEJM or Neurooncology (Lancet and JAMA are not worth the wait).
So the answer is risk the pickiest journal in the world which gives preferential treatment to lead authors or companies based in New England (neither of which applies to us here), or send it to Neurooncology and SNO whose editors and reviewers are one in the same and responsible for both executing a top notch meeting and keeping regular articles about Neurooncology flowing despite the existence of COVID like they and every other journal, investigator and company has managed to do.
I will outline to steps. Analyze the data, chose to include a SAB along with key investigator to review the data, work with lead investigators to draft the introduction (Linda Liau can take an Ambien and write that during the amnestic wakeful episode she has in the middle of the night) and discussion sections, work with your medical writer to clean those up and add Methods and Results sections, submit to the Society of Neurooncology for review as both a LBA and an article for press (the LBA can be submitted before LP and KA complete their discussion piece, but the paper would need this before completing that, allow LL and KA to use part of the weekly academic office hours which is dedicated time set aside for researching academicians to do whatever they need to do outside the lab or clinic to review comments and work with NWBO to write the response, present dats/publish data with the international Society for Neurooncology.
I believe that is six easy steps to follow in order to ensure you get both the top presentation platform for Neurooncology and the most read journal by Neurooncologists. Neurooncology is your top tier journal that provides you the highest degree of certainty coupled with the best exposure to your target audience.
Not rocket science or Brain Surgery, but I can recommend two Brain Surgeons to help out
Iwasadiver, Thank you for your dedication to the health and well being of the community that you serve, whether or not they chose to be vaccinated. Since I know where you practice, I imagine that quite a few of those people whom you move mountains to try to save from COVID fall in the camp of not trusting medicine until they need medicine to save their lives. It must be very difficult for you to leave your home to go to work these days, and likely just as hard to fall asleep at night after witnessing the devastation caused by ignorance and manipulation.
You are on the front lines of this war on COVID and given the degree of stress that you are accustomed to managing, your heartfelt words should serve as a warning to all that medicine may not be able to win this war if people don’t wisen up and get vaccinated and boosted soon.
Calling the vaccinated sheep has a medical term, it is called displacement.
While I disagree with your view on this publication situation, I fully respect you and your viewpoint.
FWIW to board members, since I know that I can be opinionated and extremely self-confident, I had the opportunity to do a gut check tonight and did.
I ran my own little informal pole of seasoned industry professionals at a dinner this evening. I asked a group whether they could give me any rationale for releasing Phase 3 trial data in a publication without first presenting the data at a congress…not one idea came forward.
Then, I gave a brief history of the situation here and asked if it now makes sense to do so. I will share one quote that summarizes the unanimous consensus.
“If you want to fight off a short attack, you want to maximize exposure not minimize it. In that situation, publishing without presenting makes no sense at all.”
It is not just me
Gary, I appreciate your desire to find a rational explanation for what may be completely irrational, but unfortunately this is not quite how the process works.
Yes, it is the primary author whom the journal will communicate with, but it is the company that calls the shots, down to deciding who will be the primary author. While it would be incredibly bad form and send a horrible message not to have LL be the primary author on this publication, the company is not required to give her that position unless the contract with UCLA stipulated that case which I highly doubt that it did. LL will require the company to provide the analysis and data to answer any queries that the editors may have. I guarantee that Marnix Bosch will also be an author which adds professional courtesy to an equation that does not require it. LL cannot put in print anything that the company does not sign off on with regards to the publication of this clinical trial data. They cannot force her to say things that she does not believe, but they can prevent her from saying things that they do not believe in that publication. Her IIT combo trial is a different story, she owns that data.
I can go on and on about this, but it suffices to say that I cannot be convinced that LL does not place a very high priority on releasing this data to her colleagues around the world in peer reviewed fashion and with urgency. I do not know LL personally but I do know the LL(s) for several other disease states personally and have had enough visibility into her thought process to say this with a high degree of certainty.
If the data is being released via publication, there is likely nothing preventing them from issuing a PR with TLD right this instant. However, if the data is being released at SNO, they cannot release a PR until SNO approves them to do so or SNO releases the abstract on Friday morning.
Anyone not on this board our receiving the insights gained here but spread through Twitter, Reddit, and Discord, only sees a company that had a phase 3 studies halted 6.25 years ago with no data released afterwards. That looks like a failed study.
Is there a plan to attract new investors? If we pass by SNO, it is hard for me to believe in that plan.
Give us an abstract or give us a PR only, but give us something tangible as to the status of the data.
The Breadcrumbs also lead to bankruptcy! Stop relying on breadcrumbs to communicate with your investors.
If the delay in reporting data is due to the need to analyze tissue from placebo patients in other contemporary trials, why not come right out and tell us that?
It would relieve all criticism of timeline management and let longs know that they wait is well worth it.
There is also the additional data that this trial is accessing that involves a deeper dive into some of the other GBM trials’ external control arms that may have, at times, required additional information that might require the assistance of specialists who have also been impacted, at times, by Covid.
Why on God’s greenhouse gas filled Earth would anyone publish data on a drug therapy for GBM (brain cancer) in any journal some time shortly after the Society for Neurooncology (brain cancer treatement) when it was feasible to present the data live and in person to those physicians (brain cancer doctors) who actually treat patients with GBM right now?
Why would anyone pass on this live, once a year, in-person opportunity with your target audience and opt to only publish and hope that word spreads?
Answer, if they are competent they would not…anyone competent would not and LL is more than competent.
We will see an abstract in just about 49 hours and a PR between 33-48 hours from now.
Why do people believe LL would submit an abstract for 2020 hoping that they could get their act together quickly, and not submit one for SNO when the data was already in her hands?
Answer. She would not.
If she did not, then I presume much strain in the relationship.
Bosch won’t be breaking this news.
Liau only…one option
They can’t tell us if they do have an abstract in late breaker coming at some point squeezed into the SNO agenda.
They can tell us that they don’t. I don’t see the harm in doing that, but lack of evidence is not evidence, especially here.
Every disease state has its own journal which is the journal. They get nicknames usually like “the Green Journal” or “the Red Journal.” Regardless of impact score, these journals are a close second to getting into the big 3, Nature not included as this is medicine. They are read by your audience.
Neurooncology is that journal and SNO is the accompanying meeting.
I am really liking the fact that Plenary session 2, 3, and 4 do not appear to be filled as of yet. The dribbling of three inconsequential to the immediate future abstracts did release and confirm those sessions also bodes very well IMO.
Keep hope alive! Today’s clues look very positive to me unless I am missing program elements.
This could be a bonanza just yet
What does your gut say? The case is curious but I feel like the dance is familiar and the song rings a bell.
The only positive thing that I take from the 10Q is that there are enough cash reserves and warrants to keep the boat floating into Q2 22 which is no small feat.
I suppose what you are suggesting is that IDH mutation is to be used as a screen upon the data rather than a piece of the data within the database. Filter out the patients as though it were performed before randomization and remove from both groups. If the originally randomized group did not separate statistically eventually over time, which I believe they have, then to remove the skew would kick it over the top for sure and be worthy of delay.
I am not so certain that could happen after lock, but I am also not certain that it cannot. I hadn’t considered that possibility. I just assumed it would be in a multivariate analysis. Interesting theory though to ponder as it would be worth the insurance that it provides. How does one obtain a clean reference database of contemporary trials? Is that what is taking so long? I can’t even fathom that.
I still think we see data soon and only three trading days until SNO release of LBAs…hard to believe
So we have two weeks around SNO and two weeks at least for vacations, leaving two other weeks to get things done in 2021. Then comes New Years and MLK and before you know it that industry, scientist, private equity conference Phacilitate.
Today, marks 14 months since September 12th, 2020. After that there are a couple more weeks in play before Marnix Bosch is set to speak, but which could be withdrawn at any moment.
Really, when you think about it, the next ten trading days is all about just one question. It has three answers.
Will TLD be presented at SNO?
Yes
No
Other
One rule of thumb that is generally followed is that you do not leave open a trial when you submit your package to FDA or they may tell you that they prefer to wait and get results from that active trial first. When your package is ready, you close the box, seal it and have it postmarked and signed for upon delivery.
I did not connect Direct to L in that way but do not disagree with that logic. Thanks, Flipper. It may have even been made clear to them that if you feel you are entitled to an accelerated path to proof with B, you connect the dots yourself to A and already have in our minds. It is a possibility and one that would likely be delivered in a way that does not allow you to publicly speak for FDA. This actually could work in your favor as you collect patents on everything. A good testing method to ensure as much uniformity as possible should be as complex and tightly controlled, validated, and assured before shipping not only to assure safety and efficacy, but also to protect technology. That too can be perfected in the meantime.
Looking at the glass and the water within is a better practice than looking at what is missing. Thinking about Phaciltate just tweeks me. There actually is a right way and wrong way to do some things and do them well. BUT there is a whole lot of water in that there glass.
Your possible explanation for what could go down as far as SNO also helps.
In LL and KA as well as all the other authors on the JTM paper, I have complete trust. This is why I will not bale for the moment or any time soon.
Management is on a trust but verify basis right now. Things are progressing very slowly if SNO comes and goes without TLD reported, so then they should verify status.
Feels kind of like a spring ready to be sprung to me.
If this was all a well orchestrated parade them let the games begin, and we all play a role in this absurd theater.
Look out for the potted plants.
BTW, the more complex the manufacturing testing requirements the better. Makes your version much harder to replicate exactly should a critical patent expire and would likely lead to full efficacy assessment of the alternative.
There are absolutely valid scientific reasons as well as other reasons that can still be communicated with sufficient and even less definition that would satisfy everyone.
I forgot to add with the previous that there easily could and should be phrases like we expect to see…by…
It is our best estimation at this time that we complete these steps by…
Next one, not likely but one can hope…
Option 2 Northwest Biotherapeutics Announces Updates to Its Regulatory Discussions
Today, Northwest Biotherapeutics would like to announce two exciting steps in what they hope will be the future of GBM therapy for all patients some day soon. NWBO has completed it’s filing of a BLA for use of Their autologous Pulsed Tumor Lysate Dendtritic Cell Vaccine and has been given the name itsabutacerca-deuceil-TL. They would also like to announce that the EMEA has accepted the SAP and will be receiving an application for licensing throughout the EU and UK in the coming weeks.
“Unfortunately, we were unable to take advantage of the unique opportunity that the Society for Neurooncology offers our investigators and staff to communicate results to the world, but we prioritized our completion of regulatory filings ahead of peer review. We continue to move forward with publishing a full review of safety and efficacy of itsabutacerca-deuceil-LT and look forward to announcing a Brand Name soon.” Quoted you know who “We are so excited about this wonderful acheivement in milestones that hope to bring meanful progress to the treatment of patients with brain cancer. Meanwhile, discussions with other regulatory agencies throughout the world continues as expected.”
If everything is hunky dory which I expect it is, then I agree that Advent may well be the best alternative available to us at that time and with that funding. It could be a brilliant way to offer herself and her colleagues backside protection if things go well, meanwhile providing current shareholders much value.
If it is not, then there is a different lens by which we should look at these decisions because if we pass SNO bye without proper disclosure of material information to retail investors there begins to be questions asked which do not lead to protection of current shareholder value (and I mean current as before warrant extensions). If there are problems which are leading to delays, then we have a right to know just as much as any single one of those warrant holders and I have two paid advertisements that say so, unless some other more timely avenue is available to them. Journals do not prevent presentation at Congress from my experience, but the reverse is not necessarily true, and besides why would you especially after telling me that you would through paid advertisements. I am not making a threat, I am making an observation and there is a big difference.
I don’t want to slip back into negativity as I wish to let those feelings go and listen to my yoga instructor when he says that you find peace by accepting and trusting in the unknown.
There is a third pathway with many doorways to choose. I will continue to provide options in my free time at no charge to anyone who cares to read.
I will work on a few more when I have time but here is a rough outline of one possible approach minus the detail that can only be added by them.
Option 1: Northwest Biotherapeutics Updates Data Communication Plan Ahead of the Society for Neurooncology
Today, Northwest Biotherapeutics updated their plans to release much anticipated data from their Clinical Trial in GBM. In accordance with prior commitments, the company will not be releasing data at this year’s Society for NO annual scientific meeting. The company remains committed to full public release with detailed review of statistical models and results of their 13 year long trial. While work continues to finalize a manuscript with journal editors, the company continues work on obtaining full marketing authorization in the US, European Union, UK, and Canada while they explore the requirements throughout Scandinavia and the rest of world.
“We remain committed to our approach to providing full disclosure of our results to our patients, providers, scientists and investors simultaneously through journal publication in a highly reputable medical journal. While SNO has been a great venue for both our research team of investigators and our own efforts in past years, we are steadfast in our desire to broadcast our groundbreaking trial very soon through press.” Commented LP, CEO/CFO Northwest Biotherapeutics. “ We thank our investors, our research partners, in particular Dr. Linda Liau and Keymours Askan for their hard work in getting us to this moment in history, and of course we thank our patients for whom we all strive to serve.”
Senti, Thank you for devoting your time to explore the depth of the SEC filings to try to answer my request and ease my mind. My reading is similar to your, and I don’t want to be snarky, but it stops short of being satisfying.
Thank you anyway and I appreciate your contributions
Outcome of a court case is opinion from just about anyone.
It is the CEOs responsibility to do what they can to protect investors from these lawsuits having any merit. There is no oversight here. So much of what we believe is predicated on trust that she knows what she is doing and is doing so in our best interests…Advent
I shouldn’t have to wait this long for the playfield to be level.
Reasonable is reasonable.
Lack of appropriate oversight creates personal liability.
Warrant extension was a gift from me to them…I don’t give a damn how much money they made, they made money or passed on the potential to do so.
A gift that I did not approve of, and despite the high stakes finagling of their own shares, we are over the shelf. I am not sure how this all ties together, but I do know that they have done things that they should not have done, i.e., ASCO 2019 and BIG BAR Show comments.
By now, there are lots of people that have seen this data. They have told me so themselves on Oct 5, 2020.
That creates quite a lot of risk as loose lips sink ships.
If I were a warrant holder and I was several steps removed from a SAB member, but somehow came across a statement from a SAB that indicated to me that we have troubled waters ahead, I would probably purchase my warrants and dump them ASAP. Has that happened?
It is not safe to assume warrant purchasing has been friendlies helping the company out. Something doesn’t seem right about orchestrating that to me. It feels like collusion and that is not an accusation, it is a feeling.
Enquiring minds want to know.
FOLD has made public their rolling BLA to shareholders, but I do not know if FDA announced anything. I am pretty certain, the only reason we know is that the company chose to tell us so. It does beg the question as to whether or not they are obliged to tell us so as for a small company with one or no products, filing a BLA is obviously material.
Material information can be positive as well as negative and shareholders can be harmed by failing to reveal positive information in a timely manner.
Lets just say I sold the shares that I recently purchased between 1.40 and 1.90 before ASCO because I believed what was advertised to me at the Big Bar and ASCO 2019, but SNO comes and goes and I believe that no progress has been made because they have not told me so and I have not been given materially positive information. Instead with all my industry experience I believe we are seeing ENMD again.
Reasonable is reasonable, and material information is required to be delivered in a timely fashion without valid reason to withhold. If they feel the news is such that it requires a medical forum to adequately communicate the information to the public….I give you SNO.
What is that about a publication now? Yes, that too is an adequate forum but is it timely?
I can believe data was not ready for ASCO 2021, I cannot with reason believe this to be the case for SNO unless I am given a reason why. Why can I say this? Utah and Mt. Sinai
I want to know the data or I want to know WTF is going on and I do not care what that will do to stock price as I believe the stock price will drop significantly if we do not see data release at SNO and are not given an explanation.
Newman, I don’t recall this statement. Can you post it and the reference?
That would do wonders in easing my mind that they are actually working hard on something as I would have something tangeable to point to that takes much effort at this stage. All that manufacturing Jazz that was in our PR is actually Advent working hard and I am concerned that LP confuses the two companies at times (i.e., that PR).