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Where I continue to disagree is that they have a fiduciary responsibility to us, their shareholders, and to expend hundreds of thousands of dollars on a hope and a prayer at this stage and in their current financially strapped position requires explanation. They do not have any remaining room in the shelf, and have already pushed the boundaries regarding appropriate use of the remaining shelf. That expenditure puts them at increased risk of bankruptcy, so my expectation is reasonable.
Additionally, they have no update to share regarding Direct which is appropriate at this time, and in that venue. They have provided sufficient visibility into manufacturing progress and any updates that they can provide could be done in a manner that does not cost us several hundred thousand dollars and risk embarrassment for the company and Dr. Linda Liau. Treating physicians could care less about manufacturing details, so any Flaskworks discussion is not appropriate for this audience as a substantive piece of that lecture.
The only reasonable expectation is discussion of results and/or regulatory status of Phase 3 DCvax-L in GBM. Anything else is a waste of critical resources at this time PERIOD.(Double entendre intended) June 4th ends the Quiet Period or stock crashes and lawsuits start to fly once again. Dropping below $0.38 per share paints September 12, 2020 in a very different light… and puts everyone associated with the company and presentations of data related to the trial in legal jeopardy.
June 4th has teeth IMHO
They do not have to order the secondary endpoints. That is a choice.
They can split the alpha between secondary endpoints instead, and I believe it was flipper or Doc that described a third alternative which I did not fully comprehend. As well, the final decision maker himself, Dr. Pazdur was quoted saying that P values themselves should not trump what is in the best interest of patients. I transcribed this for you earlier, but in case you missed it.
Biosect, I think you misunderstand my position and we, as usual, are quite closely aligned. I did not think there would be an abstract, but nonetheless held out some degree of hope. In hindsight, that hope was silly and I will get to that in a moment. I do now believe a paper will be published soon. Due to past performance, I cannot say this is certain which is what they want the case to be in my mind.
Where we disagree is on the expectation setting. By purchasing the theater which is promotional, they have set an expectation that the Quiet Period has a finite ending and that is no later than June 4, 2022 at 3 pm. If they do not intend that to be the case, they owe us clarity by way of official communication setting different expectations as this is a reasonable assumption and game time is over regarding expectation setting.
Regarding the abstract. The theater occurs on the day that the scientific session opens. This is typically arrival day for most attendees and it is wise to have chosen the afternoon as the earlier session is unlikely to draw a crowd for this reason. Timing is perfect if anticipation has been built by a paper. They will be the buzz of ASCO after that talk. Since ASCO has a strict policy about not previewing data to be presented in the scientific session, and ASCO does not allow Encore data, they would likely frown on an abstract with new data alongside Encore data that was presented prior in a theater. Any new data other than primary, key secondary and safety data would prematurely expose other plans to release top line data. This is counterintuitive if one believes in the ‘catch them by surprise’ approach which I do. I also doubt a top tier journal would agree to that approach.
Therefore, they could not have their cake and eat it too. Either they get their publication soon or they could have had ASCO abstract but both was not possible (or perhaps that other high science meeting where LL is speaking remains a possibility.) And, the theater would have been useless on Day 1 if they went the ASCO scientific session route. So, when the theater was scheduled, I should have known with certainty that an abstract was ruled out. Hindsight is 20-20, and prescient is very difficult but not impossible.
Lets hope we are prescient about the publication timing, AND that I am prescient about their having received approval to premarket promote by FDA last August.
Biosect, I was not suggesting they would or must have an ASCO abstract. I am suggesting that the Industry Theater sets an expectation for news leading up to that event. I highly doubt the Theater is the forum where they will break TLD news. They shouldn’t, it would lack credibility. I believe too that a paper is their plan, but still checked the abstracts just in case (and if we are all honest with ourselves, there was a little bit of hope associated too.)
By purchasing that Theater and putting out an exhibit booth once again they have set an expectation that they will discuss updated information and it is time to deliver. A Direct update would do nothing to appease longs, physicians, or anyone else wanting to understand what is going on with DCVax. That Theater represents the end of a Quiet Period. If that expectation was not their intention, then they should have stayed home. I believe it was, and they hoped that signal would have a positive effect. But doubt has set in everywhere and that foreshadowing has done nothing to lift the stock price.
I just went through all 3000 lines of abstract…you are right PGSD…nada.
FWIW which is not much, I did not see any LBAs listed.
There better be a publication coming soon or this could get ugly.
I find it very curious that last year’s run up to ASCO shot the share price up to $2.15, but this year, after all the positive manufacturing developments, FDA publication on ECAs, new patents, new studies, more combo data, etc., the stock can’t even break $1. Just 300 shares brings it down yet again.
It is as if someone is trying really hard to contain SP. They are in a ‘quiet’ period, and yet they bought a promotional Product Theater with plans to present something by Marnix Bosch, a scientific officer of the company. That doesn’t look very quiet to me.
$0.92 are you kidding me?
Any idea the average strike price on the remaining warrants?
They have at least about $45-50M left to fuel operations, maybe more. I think there were some $1-3 warrants out there, but that was much more closely monitored by others here.
Once they release news, that should be the windfall they need to take us to some real financing. It looks as if they don’t need BP money, it would just accelerate things. Again, a pretty good position from which to negotiate, but time is ticking. Why are all roads pointing to the near term?
ASCO continues to look like the time and Chicago the place to kick start everything.
LL is responsive to email.
Yes, they are all long in the tooth and yet this small band of disrupters keeps on keeping on to get this product past what seemed like insurmountable challenges, but now seems like an inevitable victory.
It is as if they care more about their legacy than the money.
LP is young enough to keep going for at least another decade. I like that negotiating position.
He is likely referring to the fact that MHRA can approve you to market in the UK, but this does not much more than they already have with Specials. They also need NICE approval for reimbursement.
Fortunately, NICE was eagerly anticipating this product 3.5 years ago. It may take a little while but I think we will be OK in the UK. With Project Orbis, we will start seeing the real revenue roll in from America right away, and UK, Germany, Canada and the rest of the EU will follow in due course as is typical, but possibly faster than is typical.
For the record, I hope Linda keeps NWBO independent. I want to work for her and help her launch this miracle drug.
And I’ll be so wealthy, I’ll work for noodles. Maybe with some fried pork, bean sprouts and of course peanuts mixed in.
SOUTH SIDE, BABY!
McCormick Place is also on the South Side. Just head south on Lake Shore Drive.
No need, I will buy one for you, along with a parking spot for your noodle truck. You buy the truck and don’t forget you promised me Gluten Free rice noodles.
Based on reasonable comparator valuations, I believe management would be foolish to recommend a buyout for less than $34-68.
I would accept, $22.50, however.
Dr.Richard Pazdur, Head of Oncology Center of Excellence - FDA 17:57
“Really, we don’t work for the regulations. We work for the US Govt and the US Govt are the patients, they are the community. And we have to always remember that we are not the American Statistical Association making decisions based on a P value. We have to weigh the risks and benefits of every application and every decision about what is in the best interest of the patients. And I always tell our staff that that should be our ultimate decision here. Is what is in the best interest of the patient in making a regulatory decision.
And if you keep that in mind, you will always be on the right side of history.”
https://collaboration.fda.gov/pbq6126oijaa/
I know that I am on the right side of history here. The question to ask yourselves is are you?
Thanks for the video ATL!
BTW - Pazdur hails from Chicago. A fitting place to make history
What exactly would be unethical or unscientific about waiting until after approval is certain to release results that are consistent with the analysis accepted by regulators?
What would be unethical and unscientific is to use a failed product as the platform treatment to test combinations without informing patients of the risks involved in studying one failed product versus the combination of two failed products. You could loose your license for falsely consenting patients to an experimental therapy.
Hi Lykiri, Do you know why she passed on that offer?
I don’t know how she can do everything that she does. Two children? I did not know that. I am sure she is a fantastic mother on top of a caring clinician and world renowned researcher. Heck, add neurosurgeon to that mix, MBA, and Ph.D. Is there anything she can’t accomplish?
Of course, I am invested here because of her. I stayed committed through all the pain because she is obviously the real deal. Physicians far into the distant future will learn the name Dr. Linda Liau as the grandmother of modern oncology medicine. She is overcoming death and giving people the miracle of life, all doing so without robbing them of dignity as the poisons of today so often do. She is magnificent and I don’t care that people here poke fun at me for my adoration. Her genius is lambasted and denigrated by charlatans trying to steal a buck and she deserves someone who will defend her good name from baseless attack.
It says exactly what I think it says. I can read and comprehend. There are other smart people in this world besides you, brother!
It is your OPINION that it doesn’t say what I think it says. PROVE me wrong…you can’t.
I have seen the back and forth that occurs between company and FDA when it comes to finalizing the exact analysis & output with a standard design trial, and the queries and detailed responses & adjustments in procedure that transpire AFTER the SAP has been filed and the database is locked. Establishing the exact capture procedure and validation of the Hybrid/ECA did not necessarily occur before data lock. Anyone outside the NWBO organization or FDA that says they know what happened and when it occurred is LYING. It is all speculation. Those discussions are highly confidential.
I have grown tired of YOU and your attitude towards others. I rescind my well wishes. I am neutral on you, meaning I could care less where you stand when the chips down are the cards are played.
Hey oh! Listen to what I say
We do not know when the clock will stop ticking but it is winding down. There have been clues everywhere and FUD twisters causing confusion, but take a step back and think. Think about everything you have seen, relax and decide which side of history you want to be on. To me the answer is clear, Linda Liau is pure in her motives and clear in her words, like an angel sent from God she is pure as snow and she is on the most noble of all missions, to ease the pain of human suffering. She has overcome enormous odds to forge a new path and take us to the promised land.
This well of opportunity will be closing soon. Hey oh!
LL is an amazing human being all around. She seems like she is kind to everyone and is a role model for empathy. Her ‘grapefruit juice’ is powerful stuff too. I mean look at this story…
Red57, What I see posted at CRL Memphis facility are tons of manufacturing positions that are not necessary for research production. QA/QC staffing is minimal for research production, but large scale commercial manufacturing needs a lot more attention, documentation, and hands to do so. I also see another Validation specialist (validation is a commercial product function).
This is a humongous clue and clear sign that they are ramping up for massive production. Either one of the Car-T companies is outsourcing business to them…highly, highly unlikely…or one of the low demand, rare disease currently approved, rarely used gene vector companies…also highly unlikely…or they are planning to support a new product launch.
I just so happen to know people on most every one of those other programs and will ask around, but I am nearly certain none of them are comfortable outsourcing to a new vendor at this stage and have not even come close to exhausting their current capacities.
Umibe/Ike, He and others also seem to misunderstand the difference between IP for a product and ownership of data.
It is true that NWBO is not the sponsor of the the combination studies. They are being run as Investigator Initiated Trials (IITs). This means ownership of the data belongs to the investigator, not the company. Of course, they can collaborate and cooperate, but technically NWBO has little say in how that data is handled. The sponsor, i.e., LL/TC/UCLA, files the paperwork with the regulators to approve the trial since it is still an experimental product, not the company.
This is pretty standard stuff that happens all the time. Especially, for phase I trials. Usually, contracts spell out that the IP for the product and any improvements made a a result of the work still belongs to the company or possibly shared between the two parties. I don’t see Merck people on those patent applications. I see UCLA and NWBO staff.
Neither of you know the process used for ECA and Hybrid ECA development, validation or sensitivity analysis because it is new ground. So while you pretend that you do, I will caution others not to take your views as fact.
Viking and Secure…they will do anything to frustrate and dismantle support for this company.
Please do not play their game for them. Your leaving is the intended result of the direct and indirect harassment delivered by some members of this board.
Last post of the day already, and I think we could all use a good matra running in our heads for the next week or possibly longer.
It saddens me to watch this conversation unfold as I understand and empathize with you both. Flipper, I really hope that you do not miss out on the payday that you deserve because you helped me see things that I would not have otherwise seen. The stress and strain we have all endured through years have understandably made many salty towards management. Doc chooses to empathize with them as they played the cards they have been handed.
If we can just all hold on a little bit longer, I am a firm believer that our solidarity will pay off. I would really like to see you both there with me when the Saints Come Marching In. I want to be in that number…
Biosect, you are probably right. It can be viewed as an opportunity where one does not currently exist. Regardless, every failure take a little wind out of the sails. The combo patent, however, has to bunch up the panties a little bit, don’t you think?
Again though, that could be seen as an opportunity to boost patent life everywhere… so long as they ultimately hold that patent.
Biosect, I this post wasn’t an attempt at proving an abstract is pending, just that the opposite cannot be concluded from Marnix being the headliner rather than Linda. I am 50-50 on an abstract, and 50-50 that a pub comes before ASCO. That doesn’t at up to 100% either.
I will not lose faith if we pass early June without news, but it will be a gut punch that I will need to recover from. This time it feels so right, but as any short here is more than happy to point out… I have been wrong before.
Eagle, Interesting analysis, and interesting that they continue to only look at Keytruda in that class. It could be that it is the drug of comfort, however. I agree that Merck is assuming all of the risk, and likely is at least providing free drug as they do. In my experience, companies don’t take risks on assets that they don’t need to do that with.
Generally, where there is smoke, there is fire, but not always. I once saw a show at the Blind Pig where their smoke machine went bonkers and everyone left coughing out a lung. I am not sure whether I want to see real fire or a smoke machine in this case. To me a happy medium is a partnership.
Sometimes after a fire, one is able to pivot and refocus life in a completely new direction and sometimes one cannot walk away from something so meaningful to them. I kind of want my cake and the ability to eat it too.
Voloda, I don’t think Jondoe is one of the cabal. He has been very helpful to me on another space. He knows his science but does not believe in DCVax. I think he has dug in on his position and is a firm believer in other technology.
But best wishes to you and especially to your namesake Volodimir. I never thought I could admire anyone as much as I do Linda and Linda, but Volodimir changed that. He is brilliant and inspiring with not only enough courage for his people, but for all people who love freedom.
My only regret is that when times for me in my life were the darkest, most desperate that I will likely ever face, I doubted LP. While my best friend got me through the worst that life could throw at me by keeping me focused on the possibilities that could be after I healed and the Linda’s prevailed, I could not stop myself from making desperate moves that have already cost me hundreds of thousands. I was in no shape to make those decisions and should have maintained my faith in LP because she had LL by her side.
That, however, is what the call water under the bridge. I maintained enough faith to bring me to this point with less than I had, but much more than enough. My future is unwritten, but I can tell you that it will be glorious.
Chiu, you and I have similar perspectives on the world. We should have a glass of wine together. My timing has been the worst of my investing career here, but some mountains are much taller than they first appear.
I forgot your handle. We are very close to the promised land my friend, and we will do great things after this ride changes everything.
Motto that I hear a lot. It is called a conflicted statement.
If one truly trusts, then there is no need to verify. Verifying shows a lack of trust.
Does a husband who trusts his wife hire a private investigator to verify that she is faithful or vice versa? No they do not, because that is not trust
Tomato, tomahto…
Important to you, not to me. He is on her team, not the reverse
When you are in negotiations with FDA, do you think it is wise to talk publicly about those negotiations?
If you do, you are investing in the wrong industry
What you do is institute a quiet period when it is your only late stage product.
Why, yes it is KJPunk. How about that?
Recurrent GBM with all patients receiving DCVax plus Poly ICLC, then randomized to receive placebo versus Keytruda.
Another study approved for a drug that the cabal thinks failed. You know they would have to share that with IRBs and study patients, don’t you? The failure part, that is. It likely would not be so clearly called failure but to adequately consent patients, they must be informed about what they are receiving and in this case DCVax is not the experimental therapy. It is Keytruda.
Scary story Doc, and one that I do not at all doubt.
Some people will stop at nothing to make a buck.
I give you a ton of credit for hanging around here and sharing your views and DD. A less courageous person would have zipped up.
Flipper, I totally agree with your prior point about expectations and stock price. If the company didn’t want us to anticipate news at each major conference, they shouldn’t have set expectations for news pending on Sept 12, 2020 or on the Big Bar Show.
Agree, improving. I think the evidence shows that LP is meticulous and has had a robust IP strategy all along.
They keep trying to paint NWBO management as incompetent, lost, and floundering. Just the opposite. LP has woven a web of IP protection, financing as needed, sophisticated regulatory strategy, and thought leader advocacy. On top of that she has shorts trapped in a corner and they know it now, but it is too late to do anything about it. Like feral cats they hiss and they claw, but they can’t get the noose off from around their necks. They will be euthanized soon enough.
Gamestoppers an Redditors, you are welcome to join as as we pick up your torch and destroy these bad actors once again.
Super Mario will beat Bowser yet again
Great post, HSpooner. Slide 21 demonstrates the same Direct phenomenon but in a different tumor type. Great story alongside by Marnix.