Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Extrooper, rhetorical question, but you can answer it if you wish. The point of a rhetorical question is that you know the answer or it is one where there is no right answer.
Why would anyone be willing to put money on the opposite side of the equation here and the answer to that explains everything?
Also, this timeline we sit right here in the midst of is by no means outside the realm of typical from the viewpoint of regulatory approval and has several months before any questions should realistically be made. For Europe and all that Jazz, a few more years.
What is out of whack is the timeline for TLD release. Why would anyone do that? There are basically two answers her, but add in manufacturing expansion by a conflicted company and LL never wavering one bit in her belief that the next step is adding to DCVax, not finding an alternative. That simply is coordination with company to add value to the product, AND the other choice involves activity which would be a case for jurors to decide.
I choose option one full, global approval pending. Those outside the current network either historically align quickly or are not worth the time and effort to do so.
Totally agree with this viewpoint and don’t see how logic can justify any other way, unless you are choosing to just forget the US which is 70% of revenue for most companies, except perhaps the small guy which tilts much closer to 100%.
I would add that I therefore believe FDA wishes always comes first unless they are being unreasonable and you just have to do what is best for your business. I have always said that FDA is reasonable, has empathy, and will even bend rules sometimes in order to do what is right. If they think it will be a tough sell job to the American people, they hold an Advisory committee with public feedback where they are quite literally asking patients and clinicians voice be heard. They will generally override the committee to align with patient/clinician voice, if necessary. They are very good at what they do.
I think if necessary GBM patients, physicians, physical therapist, psychological therapists and 2nd or 1st most importantly caregivers would come out in full force to support DCVax approval. I think FDA knows this and would deem that process unnecessary. They may even work to coordinate this with all parties involved, especially the EMEA, but also certain journal editors if that is best for all.
What I don’t understand is how anyone could see this as FDA not being onboard. I can’t believe anyone can’t see that is a slam dunk, AND that is my opinion
Nick, I appreciate your posting this. It is an important clue, but in my humble opinion, if you care to hear it, it is that Dr. Bosch will not be releasing any TLD or other breaking news at this event. This looks like an industry/investment conference which would not be an appropriate venue to do this.
It may, however, be there to serve as the first opportunity to spike the ball, give half the attendees half of the peace sign, and walk off stage with one great big grin. Then again, it may not but the timing looks pretty good to me as a goal for everyone involved because I think that the regulators actually enjoy when industry not only defends them but also brags about them. Generally, the relationship is adversarial but there are moments of teamwork and I think the regulator views that adversarial relationship as them just doing there job. There are times when industry admits that, welcomes their role as it also protects them, and very much understands the value of showing appreciation. They treat their employees I believe, better than any industry in the country or at least any large industry and that means showing appreciation in every way that they can.
Just popping in briefly and correcting a past error to save the point.
I have worked in the Biopharmaceutical industry for over 23 years.
Versus
I had worked in the Biopharmaceutical industry for 23 years of my career.
We rely upon specialized contract manufacturers, operating in specialized GMP (clean room) manufacturing facilities, to produce all of our DCVax products.
My favorite one in that piece which is amazingly well done and I hope that guy has more because eventually I will have to stop watching that one, although I can now call up the entire thing for the rest of my life or before getting dementia.
The piece, the one in analogue with the twist bars of color at the top and bottom most of the time
Kids these days just wouldn’t understand that or how magical turning black and white to color was.
The question I ask you, and Mike sometimes I continue the conversation with myself and not you so to comprehend watch the small incredibly entertaining documentary and relive your childhood for a little while.
Are you the rabbit in disguise or are you one of the kids, but if you are the rabbit I have sympathy for you? I do not think that you are the wolf.
Silly Rabbit, Trix are for Kids.
I don’t agree with your conclusions one bit and cannot see how you arrive at them from these quotes.
I see…let us clarify the situation and they names
Same as usual.
We need to get more specific to let you know this is very complicated. We have worked with several experts to master this. We know what we are doing.
Iron Mike - my best friend reminded me tonight… people just don’t get me, I am, hard to understand.
But thank you for leading me to this mini documentary, it actually says most of what I am saying.
Oops, I thought I saw the SNO emblem on an earlier photo, but I must be mistaken unless it is on the other side.
I will apologize for part of that post as the emblem may just be ingrained in my head. My memory is photogenic and audiogenic not associations as most people remember. I actually can’t remember by association unless that association is audio or visual. On rare occasions that can lead to me mixing verbatim memory of conversations or implanting a vision that has been burned in my brain kind of like if you stare at a light too long. It can be near verbatim because I actually replay the voices. You probably don’t believe or understand, but that is the true me, not the avatar.
And BY THE WAY…notice too another difference in the bags and I am not talking about the quality.
One says Neurooncology the other does not… subject to interpretation but weighing heavily in my favor. It is a question of whether specialty plus mechanism is similar enough to disease state plus mechanism. The reason it weighs my way is ABTA and those words BRAIN TUMOR came first. Do you understand that logic? ABTA could have been the acronym and that would have added quit a bit of confusion but they did not…
THEY SAID BRAIN TUMOR and it actually does not matter that it is the conference name, of this I have been directly told. Clarity undeniable, I will not debate this with anyone. The only choice left is do you turn and look the other way, and if you do does that technicality really matter to us longs because I can wait beyond early February 2022 but I do not have to worry one bit because LP and LL would not risk it.
She also said, properly save that tissue!
One - The registered trademark is actually critically important and connects similarly to Senti’s platform concern but a little different. No more stomping and complaining about that other DCVax folks, we have a registered trademark. The -L thing is a curiosity to me, if you have the DCVax registered, do you really ever need the -L registered when that probably isn’t the name you will ultimately market, probably.
Two - There is a timing factor that seems trivial BUT IS NOT. Did they begin a filing and when did that occur? Be reasonable sunny, please be reasonable will you?
Three - ABTA page 14, about two months prior. Sorry, Senti but this is where your fear should be erased. If the had the spacing adjusted properly I as a professional would have no criticism at all, trivial I know. They gave me something better than the data, I just did not pay any attention until the bag bc I as everyone here was so damn focussed on the data. Do you understand how slight of hand works? Comprehension matters.
Four - Either way but this is debatable, but leaning heavily my way…because if they have not filed you cannot with any reason tell me that they have not begun the formal process with formal meetings and that gets the old antenna up. Just too damn risky to premarket promote with little to not enough money in the bank and hope for the best which could range from a punch in the face to a fine likely big enough to wipe out much of that fund because it is my understanding that everyone who grabbed a bag or viewed that ad is a separate count and fine. Or the death penalty for you, not necessarily DCVax but you, yes. Why would she do this and who in their right mind has been paying any attention to this drama and can believe that she would and LL would go along?
I usually do not strike first, but when I strike back it can be quite sharply biting. So I will not apologize but I will reapeat….
Silly Rabbit, Trix are for kids
Even though the available shares for sales seems to outbalance those interested in buying right now, all that volume did mean both shares sold and bought. Someone is very smart and either accumulating shares on the cheap, or buying up in offshore accounts and settling the balance later, or going short (very smart people with very sophisticated algorithms can be wrong and when wrong are usually devastatingly wrong).
The fact that the shareholder count remains stable over the past several years tells you something…1) new investors other than the consistent proportion of swing traders jumping in and oit remains very limited, and 2) Longs are not selling out.
All that cumulative buying and selling is very interesting to see and almost always results in downward pressure despite the numbers of holders staying flat. Buy just a little news, or even the vociferous few members of this board like me who have pumped a potential release, drives the stock sharply higher.
What does that scenario tell you?
I know what it says to me and that along with all the other “breadcrumbs” some of which have laws associated that are there to protect consumers and investors from lies, has me sitting here joyfully watching the clock tick tock tick tock.
Despite the fact that my adrenaline will spike very high when that cuckoo surprises us all and starts chirping 12 times, those short and manipulating this stock downward will have their fake chariot turn back into a broken down, slop hauling, two bit wagon. I hope that wagon breaks so badly that they have big trouble delivering on their required promissory activity and go belly up.
What a joyful schadenfreude I will have to see AF get lambasted again when he is even more wrong than he was about Dendreon (pre commercial flop of course bc I got out between $22 and 51 on my average $1.20 investment before that occurred). NWBO however figured out how to make it better and much cheaper to be very profitable.
If you don’t agree with the UCLA bit, write them a letter think about adding a copy to a BS attorney at law, and force them to respond appropriately. Make them aware if you doubt.
Hoffman, I understand where you are coming from and please understand that when I believe a criticism is unfounded I respond and sometimes sharply. Let me perhaps explain more clearly because I do believe you and many others misunderstand my beliefs, and have read into sincere statements improperly and have missed sarcasm or A Modest Proposal or two as such. Even my friends.
First, you do not fully grasp the idea behind the half of the complete criminal conspiracy theory that I laid out without making that accusation but definitely alluding to it with authentic emotions of anger, stress and paranoia which you may not believe and I know my many of friends do not fully believe was all preplanned and intentional but not my true belief system. Authenticity is always important and really cannot be faked, but can be given into when it comes to those three emotions. Here is where SNO fits in and to a lesser but one could also argue more degree ABTA. First though, lesser or more because ABTA is both patient and physician. ASCO is not but by the very nature of what and how they did it, made it both.
So again, if DCVax(R) (notice we all never say -L, and that the L is not a registered trademark but is one of 3 options available at www.nwbio.com where we are directed for more information) is not Safe and Effective for the Treatment of newly diagnosed GBM, then I do believe both the SEC and other regulations and laws require this information be corrected in a timely manner once they know that statement is not completely true. I have been convinced and was so immediately despite being one of the first to raise it, that the 4 day rule does not apply in this industry when it comes to studies. Reasonably timely manner and appropriate venue though does, and that was exhausted by SNO because they had access to the press room and other alternatives despite not having an abstract (referred to as a paper by the more refined) presentation. Again in maybe a minor technicality to some but not when intertwined with everything else. If I see that, I dang nabbit Gaur-un-TEE she did and would not, but certainly made it look like she is hiding something which she is….I will add another puzzle piece for you and there are so many more yet in my bag.
Here is the catch, both the Queen’s legal team which also has rules about this stuff, and UCLA’s team which is on US soil would not let this perpetuate past those dates without officially distancing themselves and requiring her and him to do the same which THEY HAVE NOT. Get it, got it, good. Quite the opposite, as every neurosurgeon in an English speaking country should be saving tissue properly and not in paraffin or so I am told!
Now, to the original question of the bag and its meaning. It means that they started a coming soon campaign when the ABTA full page advertisement was posted which started a six month clock and this is a dying belief that will not be changed despite what may come. The catch is that there are reasons that it could go beyond six months such as COVID, an official FDA delay which may not require posting and may not portend anything, or an unofficial indication which is known to happen as I witnessed it once that we will look the other way because we understand and sympathize or agree with the intent. Any of these could very easily happen but are all a clear reassurance of approval.
OR LP could have broken a very important rule here and across the pond. She could have done that unknowingly, but do you believe that and she is an attorney so the standard is higher?
Your choice, but my answer is Tick Tock, Tick Tock, Tick Tock the cuckoo strikes variably but with 85% certainty by mid February, or 15% certainty later that year.
Tick Tock, Tick Tock…my grandmother had a grandfather clock and my mother collected German miny Glockenspiels… I like to watch clocks. It gives me pleasure and calms me greatly, even though they come with a surprise…Tick Tock, Tick Tock.
I appreciate your response. I have worked with someone by said last name and they would be able to put two and two together rather easily to identify who I may be. This is not my first rodeo as Dendream and a lot of people have listened to my passion about NWBO and are invested heavily. You confirmed that you are not him/her, which actually gives me quite a bit more confidence because he/she spent a good deal of their career in new product development, specifically the marketing side of that team. I am not a physician and have stated that consistently many times. I just gave you a clue that I have refrained from previously as to what my training involves. It is more relevant to these discussions.
I am not a rare unicorn by FDA definition but I am uncommon.
I have done step 1 and it was done for others here. I trust step 2 and 3 to professionals more trained, experienced, and who have actually spoken with FDA about issues like this. I do not need to do the research because lack of evidence is not evidence. I have run a coming soon campaign at congress and taken part in others. As I said, small companies can make big mistakes. The question is whether or not that is true of LP and LG. It sounds like you believe that a company in the midst of a regulatory process in the US has free will to do and say what they please…they do not. It also sounds as though you remain stuck on the second step of a campaign that began two months prior.
A question for you. The excuse for taking almost 2 years to lock the database is SAP and IDH. The excuse for delaying TLD for over a year is the need for third party, expert validation of the science. What is the excuse for not beginning a regulatory process by mid-summer? Would something that anyone can come up with involve FDA negotiation which means process and gets antennas up?
The purpose of legal disclaimers is protection but it is also a demonstration of competence. As are my other posts to you.
I did not know that…we have an answer then to a few of the how questions?
The US has several established options for this type of service and I am sure CRL is willing to step to the table.
We live in a world where people believe silly conspiracy theories rather than obvious facts. They don’t use any logic or they would realize that if there was any truth to those silly theories the other party would be pursuing investigation and criminal charges. Instead, they believe clearly biased pundits who spew lies on both sides of the aisle while the extreme rich get richer, or institutions that people rely on like Social Security and Medicare quite literally implode in coming years and bad actors run amuck throughout the economy. Just look into where your farm and oil subsidies go and you should be appalled but unfortunately we do not and are not. Do Bill Gates and Ted Turner’s estate really need any more money from tax payers? Do oil companies need additional incentives to drill baby drill? Should insurers be protected from denying critical care like cataract surgery? And America turns its stink eye on my industry who works to actually cure what ails you and bring it to you at what usually amounts to little or no out of pocket costs. Meanwhile, we all love to invest in that which we hate.
It is called the fleecing of America and the “sheep” are a large proportion of both party constituents. Smoke screens are their primary weapons and they are very effective. Those currently using that term have not looked in the mirror or observed who makes up the vast majority of the 800k US COVID deaths. Let me give you a hint, they weren’t vaccinated and Pfizer, J&J and Moderna are not secretly implanting trackers into society. Cookoo bananas.
I understand the distaste for mandates. Where was it when your kids went to school and your HCPs went to work in the past? There are many mandated vaccines.
Who is going to backfill all those baby boomers and stay home parents that we need to pay taxes to fund everything government? We need those “demons” and our economy needs them right this minute.
Gary, I don’t disagree that the money may be there to keep the lights on until we have our crescendo.
OR, it seems to me that they have gotten more warrant money in the past 6-12 months than was needed to cover the day-to-day operations by the pace that was established for a couple years now. There are people closer to these numbers than me. Where has that money been put to use? It looks to me like some of it went to Swaston build-out and staffing, but I think perhaps there should still be a little left over for perhaps a new Cognate contract as well.
Now they have $20M banked. If you believe like me that approval is coming before mid-February, and TLD publication and Swaston approval will preceed that which will lead to more warrants being exercised and they have no intention of initially hiring a sales force but will rely on CRL or one of the contract staffers to run a customer service line only. Then that may be just enough money to do the bare bones necessary to be ready to manufacture and distribute drug. I have no idea how they intend to get insurance coverage or support physicians and patients with that process and/or subsidize those needing help without commercial operations but maybe they plan to start slow and grow or sell themselves first.
OR maybe they already have the outline of a partnership/BO deal in place and all they need to do now is get the essentials in place before Merck, BMS, Amgen, Roche, Gilead, etc, etc take over. The thing I don’t like about this is just that, the list that can be made. Why would you lock someone in rather than create a bidding war?
In my experience FDA can and does share draft guidance with some or all and let them start to live by that guidance before it becomes official. It is kind of like a beta test.
If the guidance is changing, they may have communicated the new guidance to NWBO and allowed them to begin the process and by sharing the guidance has all but assured them of the success of their new approach. In fact, they have been known to tell you their true target approval date which is not a guarantee but is a very real goal and much earlier than the PDUFA date. Companies need to prepare for an approval and they need cash to do it. You have materials to print, websites to build, phone lines to activate, and supplies to purchase. They understand this and work with you, not against you. If it is coming down to PDUFA and you don’t know what they will do, that is not a good sign at all. Not necessarily the death nail, but not a bed of roses either.
Oh yea, you also have contracts to execute and manufacturing suites to secure and staff to hire…
I don’t know, maybe you need an extra 15 million to get’er done and be ready.
Hoffman, on a separate note…
I have my issues with what happened on Sept 12, 2020, but here is my view of our legal codes. What people can gripe about is called FRAUD, except that it isn’t. For criminal fraud, the perpetrator must understand what they are doing. They cannot believe what they are doing is not right with a degree of plausibility. LP being a fine attorney in good standing would know more about this than most and is held to a higher standard of ethics. Therefore, my conclusion is that on 9/12 it was possible to lock the database and deliver results by the end of September. When this changed, she informed us all in a timely manner. As well, no one was harmed. The stock price grew and never again fell below 0.38.
Why would she do that? Come up with a few valid ideas and get back to me if you wish. I have given my theory.
Oh, yea. Thank you Chiguy… Go Hawks! Go Bears, next year!
Thank you Survivor! Hoffman, 1 more ting..
Hoffman, sorry to go back so far in time and to revisit this conversation about premarket promotion yet again, but I got a private message that I just read which made me go back and reread posts from that day. You said…
you have no legal background and no basis to opine on how the FDA interprets these rules.
You know, if the Pizzagate conspiracy were true that would be a crime. I think there would be a lot of effort to prove who the parties involved are, whether or not they committed the crime themselves.
I didn’t say that there is no conspiracy, I just indicated that I don’t believe the conspiracy includes LP, LL, KA and MB.
We are all frustrated by the time and process, but imagine what it must be like to be a neurosurgeon that took part in the study other than LL and KA. They are helpless to save their patients but see Keymours and Linda saving patients with the therapy they too have used but cannot use now.
The best they can do is follow the advice of LL and properly store the tissue. Why would she say that? Do you honestly think LL is part of some conspiracy to defraud investors? Now she is advising doctors and patients to waste precious resources? Really, that is what you think of LL?
She hasn’t distanced herself from the company or the drug. She continues to preach about its value and research how to make it better. Meanwhile, she and Keymours keep treating patients. In the later case, he is asking patients to raise £150k of money that their families would otherwise need to carry on. Is he part of a conspiracy? Is he heartless? No
ABTA advertisement was posted sometime in August/July. People think the tote was silly. The full page advertisement clarifies the platform doubt that the tote left open-ended. Their PR this week refers to brain cancer multiple times. Is LP that sloppy? Is she leading a conspiracy as bears would have you believe?
LL recommended saving tissue around that time. She presented the shell of the analysis in April. January is 9 months after the Utah talk. That seems about right to me. MHRA certification is expected within weeks and Marnix speaks publicly on DCVax 3weeks after the holidays. Is he part of a conspiracy too? He did do that talk from the Advertising Hall Product Theater that was projected round the world and included patients flaunted as cured. He must be in on it, huh?
Is LP sitting on information that would lead her to believe that approval in the US is at best a long shot while she advertises DCVax for Brain Tumors in the US and collects warrant payments and monetary loans with no collateral in the US? Really, you believe she would do that? Would she put out a PR indicating plans to raise money following TLD presentation and tie that loan to stock conversion to the stock price of that private placement within the next 8 months? Really?
There is so much more than this that points to a conspiracy if TLD is negative. If FDA doesn’t accept the new endpoints, TLD in the US is unadjusted PFS. Really, she would do that? All on US soil?
That to me sounds like someone who believes there will be a near miss on the original primary, but a hit on the secondary. She seems to believe that a subgroup that was not prespecified will show positive outcomes on both. IDH mutation was not prespecified
Progression is a surrogate endpoint. Surrogates are believed to adequately correlate with the true endpoint which in the case of GBM is death. If survival is positive on the original design but progression only trends, it is statistical garbage rules that cast doubt on efficacy, not the data itself. A p value of 0.06 says there is only a 6% chance vs a 5% chance the outcome you see is actually just chance. But the p=0.06 gets rejected…crazy stuff to most clinicians.
I think we see positive across the board if IDH mutation is accounted for and if not then 5 out of 6 with the 6th trending close to positive (non-adjudicated PFS) when all is said and done. Most patients that survive never progressed according to LL.
10bagz, Thanks for the reply but I was referring to the ABTA site that I had attached. In addition to your numbers for shares you need a date and a stock price on that date to make the calculations.
Strength and courage along with my best wishes to your sister and family.
Come on now. There has to be at least like two or three weeks of onboarding before you can honestly function in that job. What are you gettin’ at there AeK?
I do have one criticism about page 14 of this Program Brochure. It is that there should be an additional 6 pt font separation between the last/first green line and the font section. Visual balance is also important and that is tongue and cheek for my legal-reg friends.
https://www.abta.org/wp-content/uploads/2021/09/2021-ABTA-NC-ProgramBooklet_Final.pdf
Alright, that was one more when I said that I was done. I couldn’t help myself. I am feeling snarky this morning, but in a fun sort of penguin puppet kind of way.
What they gave you folks is better than the data and they did so with a Platinum Sponsorship before my rant about SNO. I just wasn’t paying any attention because I was so focused on the data.
I apologize David, and more importantly Linda.
Let me say one more thing once and for all and I will move off of this topic of advertising in the Biopharmaceutical Industry, the most regulated industry in the USA.
FDA and more precisely in the post market setting DDMAC or its biological equivalent which we all still call DDMAC, can and does constantly enforce their marketing rules even when they lose in the Supreme Court of this land which they have done more than once. This can range from a gentle slap called a Letter of Notice to a warning punch called a Warning Letter to fines and beyond. They can and do connect phrases in space and time meaning they do not have to be connected in one piece, the context is evaluated at large, although usually they do limit it to one piece. In the premarket setting they generally look the other way very early in development for everyone and in the midstage for the little guy. When you cross the line and formally enter the process they watch everyone very, very closely and penalties can include death figuratively.
If you believe DCVax is a platform technology then I say how many of those technologies are personalized immune therapy for Brain Tumors in human investigation, sponsored by the company?
The answer is one, and that is precisely how FDA sees it IMVHO. And that is a registered trademark.
It is also clearly and without dispute by the cabal of doubt casters a full page advertisement.
So they marketed that drug at ABTA which starts a clock that ticks for at most six months or there could be severe consequences IMVHO.
Flip thank you for that condensed and clearly laid out history of major milestone events. Sometimes it is quite enlightening to see the forest while trying to organize the trees in ones mind.
I would say that while the pace may be slow, add in all the details we know of data and patents and financings and skullduggery etc, etc, etc and you can see a ship that has been steered with a skeleton crew not just competently but expertly through high seas and tropical storms and is arriving at its destination with its cargo intact and its bounty of fish even larger.
Thank you for your leadership among the rag tag band of militia men and women who have fought bravely and passionately awaiting that vessel. Victory is at hand my friend and the spoils will be bountiful!
I was not an investor in CVM so I have no idea about their story. You claim they are similar. Did they have an enrollment imbalance as a result of a halt in new screenining but continued enrollment?
If not there are no similarities.
Pseudoprogression may be the answer as to why NWBO needed to provide additional information after the decision to continue was made. It answers the question of why you would continue the treatment regimen even after the primary endpoint at the time was reached in an individual patient. Had they stopped treatment in those patients, then you would have a classic crossover design trial, but they didn’t because that would be unethical to do to those patients.
If there are fingers to be pointed as to why this has taken so dang long, those fingers should probably be pointed at FDA. I am certain LP spoke with FDA when they chose to go past 248 progressions, 233 deaths, before they published in JTM, and before taking almost two years to lock the database. They could have verbally given guarantees but obviously they did not.
She was referring to the halt overall IMO. Can’t be due to pseudoprogression because patients continued to be enrolled for the next three months and all were placed on active therapy, none on placebo. The trial was never halted. New screening was halted when enough patients were screened and could be added to complete enrollment in the treatment arm.
If there were any question as to the safety of DCVax, there is no way FDA would allow new patients to go on active treatment until that was sorted out. If there was still a question of efficacy, placebo would have been retained. If it were a question of manufacturing and/or storage, no patient new or existing would have received active drug until the manufacturing issues were sorted out which would have taken months to years.
There is only one plausible answer to a screening halt that continues enrollment with all new patients being placed on active drug….oh yeah, and keeping an EAP open in case the company chose to make drug available outside of a trial.
EAP is short for EARLY ACCESS Plan.
To my long friends…
I have found that the most effective approach to conflict resolution is to reach down to the level of your opponent, do so with great sincerity which means I needed to give in to my emotions, and then raise them up to your level.
I apologize to all for using conflict resolution techniques that I have found work. But they do work.
Go back and you will see that my conversion happened before the bag, and even before LBA deadline.
Does time, actions or lack there of create certainty or uncertainty?
Did blowing past the PFS trigger serve to create certainty or uncertainty?
Did continuing on past 233 deaths serve to create certainty or uncertainty?
Did extending time between preparing to lock the data in Nov 2018 to actually locking the database in Oct 2020 serve to create certainty or uncertainty?
Does testing for IDH mutation in the database serve to create certainty or uncertainty?
Did LL foreshadowing data analysis, likely outcome, and future research directions for GBM serve to create certainty or uncertainty?
Does advertising your product (technology or vaccine based upon your beliefs) serve to create certainty or uncertainty?
It is up to you whether or not you are certain of your investment thesis.
I know two things for certain. First, the only rationale explanation ever offered regarding the Halt in use of Placebo during the screening and randomization phase of the trial is that the DSM saw a clinically meaningful difference in death rate between DCVax treated patients and placebo treated patients and called for a halt of the trial. LP refused the halt and the rest is history.
Second, FDA granted Northwest Biotherapeutics and Early Access Program which was employed for a period of time. EAPs are only given to promising therapies that have shown sufficient evidence of both safety and efficacy so as to deem them appropriate for broader use outside the trial. This EAP is still active. It was not taken away from them, although I am not sure why it has not been employed to offset the fees paid to Cognate. They already had sites up and running with it but then stopped. I have a theory which I may share at some time with you and it is consistent with most everything I have put out there. They never needed “Right to Try,” they had been given the right already. They could have restarted today if they wished to do so, except they can’t.
All the other stuff that causes angst and churn IMO was to create FOMO so that retail wouldn’t shoot itself in the foot and kill the plan. I just wish my wife would allow me to take advantage of this opportunity. But like TRYN2, I fear what could happen if I did.
And BTW, those early people who died after getting placebo, never had the opportunity to be forced on to therapy. So, you could never get to 100% treated, only >90%.
Biosect, a friend who has a friend who is very close to this situation reminded me something this week. Longs all know this, so I am about to say something we all know and believe but it is still good to be reminded.
We are not looking at two people working a J.O.B.
We are not seeing a small group of people turning a quick buck.
What we are seeing is two women and their teams who have dedicated their lives to easing the suffering of other human beings, not just people they know and love, but for humanity a large.
To quote Phil Lesh, “they say love your brother, but you will catch it when you try.”