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Totally agree reachjo.
LL would have stopped talking about a failure a long time ago. Like 2016
This was not the newsworthy event as far as I am concerned. The event is pending. This was premature baking, but a welcome update. This one seems responsive to me, as was ASCO comments and several before then. They read this message board.
Call me crazy, but I actually do believe management is responsive to shareholders on this message board. It is once in awhile worthwhile to kick up dust because we just got the update we were demanding as this tide of longs was palpably restless. Now, I am settled back into to my confident self.
Biosect, I respect your views and largely agree with you on most things. I and many of my colleagues have been heavily invested in this stock since 2013, so I do call that patient investing. Guidance is cheap to produce and can be updated when new information changes a forecast. Their latest forecasts are starting to emit the odorous scent of rotting from decay. We are simply owed an update and a level playing field for investors.
Something tells me there are longs with NDAs who have been reassured and provided updates. To me, a quiet period is realistic , but only for so long. If SNO comes and goes, we deserve updated guidance, period.
I so badly want to pump the hell out of SNO, but I just don’t have the faith to do so which concerns me. No SNO update would tell me LL is not influential in driving the clinical communication plan.
Biosect, we are now 7 months out from the ‘coming months guidance,’ almost 13 months past the datalock and outline of steps being taken, and 5 months past these guidance being reconfirmed at the ASM. Let us not forget that we were told in November 2018 that, the company was taking steps to move to a datalock which occurred 2 years later without explanation from the company. We are three years out from that statement…3 years, 3 of them. We were told MHRA certifiaction would come around the end of Q3. November is the middle of Q4, not around the end of Q3. I have been extremely patient during these times but if SNO comes and goes without an update, my patience will end.
They flat out owe shareholders an update within the next 3 weeks. We have speculated a story that fits the timing and current state of affairs, but it is time for clarity in forecast. I Still hold out much hope that SNO will be the catalyst, however, after that there is literally nothing left to point to for optimism. Longs need some reassurance and they need it soon.
Only a slight difference…99.5% on new primary. 80% on old primary
Sojo, I have appreciated your education on charting and have found strength from your posts during periods of uncertainty. I hope you reconsider, and continue to play a role on this board.
Good luck investing!
By now, they must know whether or not the first journal they submitted to intends to publish the manuscript. They are likely working with editors on final touches or working with the back up journal on first review. In my opinion, there is very little chance that Neurooncology would refuse publication. The question is with NEJM or Lancet, although I don’t believe Lancet should be in consideration anyway. Everyone reads NEJM and all Neuroncs read Neurooncology, Lancet is close but neither. NEJM is worth the effort and wait, but I still may have chosen the Neurooncology route first as I think the time for risk taking is over. LL likely would disagree. NEJM is the crown jewel.
My guess, FWIW, is that publication in the primary target will occur within the next 1-2 months or we will see the back up journal publish the results before March 2022. My gut says NEJM would want to publish this one. It will be a pioneering article in many, many ways.
Sometimes it helps to draw the straight line that connects the dots. Thank you Hoosier. Intuitive people see the constellations in the sky and understand they have meaning even if only Aries is overhead so it is time to put the corn seed in the ground,
I for one don’t have a problem with the people who built Cognate and Advent being rewarded for their role in this endeavor. I don’t disagree with those that feel cheated a bit by not having a stake as well. You can agree with both sides. Either way, they point to the same thing brother which is all good.
How are your Hoosiers going to fair in Big Ten play this year? It doesn’t get any easier each year in the league even when your team matures. You can have both the third best Big in the league and third best in the country.
Ask Jackson-Davis how that feels?
And BTW, I thought I was past all that investment advice mortgage your house BS, but I will add my legal disclaimers again if need be. And I can show you over time how I can use those same disclaimers to be understood as just the opposite of what they disclaim.
I am not an investment advisor, I am not your investment advisor, make up your own damn mind and your make own decisions, and take ownership of those decisions because no one cares about your money but you, and that is a double entendre. I am not a physician and I am not offering anyone on this board any medical advice. I am a clinician but I am not your clinician and I am not analyzing clinical information for your personal problems either with exception that I would be happy to analyze a set of references and the corresponding presentation for Iwasadiver anytime he asks, just because I honor Spartan medicine and did a tour of duty in an inner city ER so I know the grit that guy has got as a physician. He sees everything at least for a window in time and is called on to save peoples lives in many different ways and meanwhile teaching your kid how to properly use his inhaler too because America thinks the ER is an acceptable primary care, especially if you are poor from a place like Lansing, MI.
And then again back to the words in my mouth bit. Please don’t tell people that I said to mortgage their homes for this stock. I don’t have a mortgage myself on any of my properties, so why would I advise someone else to do what I would never do myself. Ethics matter my friend and most of what we do, say and act in life is a choice. Please realize that investment advice chatter you are hearing is an echo of your own voice…de facto…de facto…de facto…mortgage…mortgage… mortgage
Ahp123, First, off I find your handle to be awkward…kind of like conversing with a robot R3D4? It has got no personality. I guess that is on me.
I find that some people’s form of argument or ‘style’ of debate is to put words in others mouths and then argue that point. That is defacto arguing with yourself, so you both win and lose that one, buddy.
The FDA logic you outline are your words, not mine. You must not read many of my posts to know that I firmly believe with very little uncertainty that your suggestion is not typically how FDA communicates anything. Defacto, this defacto that…FUD this, FUD that.
The means, regularity, process and style of communication by FDA is precisely why we stand here, and a good R3D4 should be able to compute and pick up what I am putting down or you can put words in my mouth and argue with yourself some more. My 100% confidence that if FDA approves the primary endpoint change then we have victory is my opinion and confidence is an individual belief. I am 100% confident to fly in a metal tube, but others would not agree with that statement and can offer quite a bit of data to the contrary, but that does not diminish my confidence 1% every time that I step on that plane.
Perhaps we have come to an agreement of sorts (and perhaps we have not). While we agree that FDA represents uncertainty, our agreement even on that depends…
How will others interpret my reply? Well, that depends.
Depends on what? Well that depends on whether they have read my prior posts, your prior posts, how they compute that data themselves and to what magnitude this basic argument matters at all to the significance of the overall result…so you see, it depends.
I will tell you that without any inside information whatsoever, I am quite confident that they have had several key discussions with FDA throughout the process that began on Aug 2015 and again since Nov 2018 There have been results produced and publicly shared that will be part of the data package. As it is public FDA has evaluated that information as well. This is not just window dressings, the EAP data counts and is part of the package, as an example. You have more public looks behind the curtain than you may think. FDA has been watching and involved since 2015, before really, but I mean involved not just oversight.
Now where they land on the new SAP, well that is the question on which our entire game here is decided now, innit? You have your thoughts and I have mine. I have quite a large chip on Linda and Linda, and I have been sleeping well for some time now. You decide your own state of mind.
Where are you coming up with this percent difference criteria? They don’t exist.
If you are extrapolating power calculation parameters, then you prove that you do not understand clinical statistics. BTW, if I am not mistaken TMZ grew mOS by less than 20% relative to control which was both clinically and statistically meaningful, despite all of the problems associated with looking at the median as the endpoint.
I didn’t say 100% approval, I said IF FDA has accepted the new endpoints, then it is a slam dunk. There is an awful lot of uncertainty relative to the first part of that statement.
If you have any doubt about the new primary endpoint being statistically significant and clinically meaningful, then I can only conclude that you do not understand data and/or clinical statistics. I can say with 100% confidence that the new primary endpoint is both statistically and clinically significant. I once worked in oncology as a clinician so I actually can say the later part with credibility, but it does not take that experience to understand that preventing death is always clinically meaningful. A Kindergartner that can trace lines can see that the first part of the statement is true (even if you shift the line by 6 weeks), but go ahead a FUD all you would like. It does not change my view or my holdings, or any other long on this board for that matter.
Not sure where you come up with a 20%, 30%, or 50% requirement for that matter. The standard is statistically significant and clinically meaningful with acceptable risk-benefit. These are not translated into minimum thresholds, but rather taken on a case by case basis.
We will easily reach all three, statistically significant (even by original randomization, but without doubt on the new primary endpoint), the primary endpoint is death so clinically meaningful is an easy bar to pass, and there is no risk with DCVax. So long as FDA has accepted the new SAP, the result is a slam dunk.
You are suggesting that for LP to have acquired Flashworks and its patents rather than license a competing technology that may be able to be adapted to DCVAX-L as well is somehow shady.
This is the reverse of the logic used with regards to the Advent relationship…naughty, naughty, you should not be contracting manufacturing when you could be keeping those profits in-house.
You see the contradiction in logic juxtaposed in one post? Understand what that means?
Flipper your knowledge and memory for history in this company is only surpassed by your ability to synthesize this into LP analysis. Thank you.
If one could have read the tea leaves then, would that outside person have been able to see the future timeline?
I think it probably would have been impossible to see but you have a more keen view on this perspective. The breadcrumbs over time, however, I do believe add up to the complete loaf at this time with one amazing finish coming soon. I wish I had the conviction at $0.24 that I did now. I can be patient. So I stand put here and now waiting patiently at the station as I watch the train slowly getting larger and larger.
Dude, I am sorry to hear about your friend. Hold out hope and encourage him to do the same. My friend continues to do well despite not receiving DCVAX, although I am not certain that he would still be diagnosed with GBM today as I don’t know his IDH status.
Keep the faith, positively matters
Aside from all of the data arguments and comparisons that can be performed using Mar 2017/Nov 2018 blinded data and the April 2021 contemporaneous control dataset, there is one irrefutable fact that proves the results will be positive.
LL and KA continue to talk positively about DCVAX in public forums. They don’t just represent themselves, they also represent UCLA, King’s college of London and the Queen of England.
Anyone who works with internationally recognized thought leaders knows that they would bail out as soon as they know negative results. They would present those results one time expeditiously and then walk away. The fact that these two will without doubt be authors of a publication and therefore have seen the data already, but continue to speak positively about the future of DCVAX in the treatment of GBM is all the proof I need.
Listen to the experts, not the negative peanut gallery of IHUB and
Relax, Don’t do it, When you want to go through with it, Relax, don’t do it, when you want to sell
Cha-Ching!
Well stated, Doc
Looks as though the entire gene editing market took a hit with the news of Allogene’s HOLD for their Car-T program…I am not certain this is a bad thing at all for Precision Biosciences. Time will tell but this could be a process specific issue.
After the U.S. Food and Drug Administration (FDA) ordered to hold the clinical-stage biotechnology company’s AlloCAR T clinical trials. Notably, the company develops allogeneic CAR T (AlloCAR T) therapies for cancer.
The U.S. regulator’s decision followed a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient, who was treated in the ALPHA2 study. The abnormality was detected in a bone marrow biopsy that was undertaken to assess pancytopenia (low blood counts). Notably, an investigation is in progress to detect further implications, if any.
Following discussions with the FDA, the company is likely to provide additional updates. Markedly, the end of Phase 1 materials, which were submitted in anticipation of an ALLO-501A pivotal Phase 2 trial, is under the FDA’s review.
And LL already presented the first paper and her peers loved it, see also Utah followed by Mt. Sinai lavishing praise. The second paper got the biggest foreshadow in history with JTM, SNO presentation, and a sprinkling of multiple top honors to LL.
Strike up the music, the band has begun…da..da..dada
Our Bill Murray almost has things set right in the world
Diver, no doubt “b” is more likely, but I think there are two papers. Published and reviewed simultaneously
One outlining the methods for building and validating the external control arm and using it to create a supplemental hybrid control arm. AND ONE demonstrating the break-through therapy for treating the most hideous of cancers known to man and curing a significantly large portion of them, a cancer that before killing you takes away your very own self, your personality, and leaves those you love with horrific final memories of your life.
Two papers take longer to write, thus a 2-3 month process turns into 4-5 months, but the six month review still stands. IMO
I like your math, even if $150k is too low in my opinion. Firmly puts me in the nothingburger camp once again.
Darn it!!!! Serves me right to get excited
I am picking up what you are putting down.
Let the games begin! I don’t sell a share less than $10
SHA…SHA…SHORT SQUEEZE!!!,
OMG Flipper…you just broke the biggest story of the decade
BTW Anders, I am an American, proudly, and Thus I only fluently speak English, once spoke fluent Spanish (Mexican version) and dabbled in Swiss German for necessity. My guess is that German is not your first language.
Why? I find German speakers to be the most polite language users in the world. If they speak your language, they will only deviate to German when a colleague needs help translating. Most all speak English, usually fluently, unless uneducated. They will not exploit the American language weakness in my opinion as other Europeans frequently do. It is fun to be with an Englishman in those settings, because they often understand your language but will only speak English so you may not be aware. We native English speakers are quite stubborn about our language.
Unfortunately, this is an example of the typical process. After gaining EMEA approval you must go through the independent national process to market within that nation. Healthcare differs from other EU relationships in that much of it is nationally funded. You negotiate pricing in most to get local authorization.
Generally, Germany then EMEA is parallel path and one needs strong rationale for this path to open in Germany as far as I know. Fumaderm is an older drug, not sure its even available now as the company was taken out to make way. I am aware of a few others but that could give away some degree at least of my anonymity, so you are on your own to research this topic.
With, not for…they speak fluent English, no translation required for an American based company.
One rarely used strategy to gain full EMEA approval is to first get approval in Germany. They are far and away the biggest market so if this accelerates things by a few months in Germany, it will occasionally be exploited…as far as I know, but hey what do I know?
Then I wont share my experience working with BundesInstitut and PEI. While being the main contributor to the EMA CHMP, they also operate independently. Rather than search for more I just posted you one example of a drug only approved in Germany
Certification for Good Manufacturing PRACTICES. cGMP not cGMS (site)
I realize this is news to many longs here, but I have understood that NWBO has had no interest in manufacturing DCVAX themselves for many years now.
If there is new interest in investigating claims of illegal self-dealing, perhaps one of our legal experts here can provide insight into the regulations that protect minority shareholders from insider misconduct. BUT, as I recall this debate started because of outrage that the manufacturer of DCVAX in the UK is going to receive certification to manufacture in the UK. Are we also outraged about Franhouffer? I assume they hold a certification as well. I assume we paid them for their services too.
Outsourcing manufacturing has been a consistent business decision for as long as I can recall. There is absolutely nothing nefarious about the production company holding the certification to manufacture. They are not upstaffing in advance of an application to do nothing.
You may question whether this was the right decision…then you should also question your own DD.
You may question the appropriateness of the Toucan-NWBO relationship…I have no expertise so I assume if there were no illegalities in the Cognate relationship, then there is even smaller odds that they did anything wrong with regards to Advent. I may be wrong here….
Perhaps an attorney can give a legal opinion on that topic…do we have any here? I think we have a few who make that claim. In my experience, practicing attorneys are quite careful to throw out accusations of wrong-doing, Rudy Guiliani excluded.
That may help longs look into the mirror and ask themselves who is to blame for the misinterpretation of the Advent relationship and the decision to outsource manufacturing. I personally don’t like it but I chose to swallow that bitter pill several years ago.
AND I accept my responsibility in making the decision to invest despite what I thought was a poor long-term decision. Sometimes in business, short term concerns prevail over long term interests.
Again, I would be very interested in a legally trained poster to share their interpretation of shareholder rights. I am open to changing my opinion.
Sharpie this is beautiful, Thank you for posting.
Lining up again, they are lining up to be early in the education process.
Jack, I am not replying to rekindle this discussion but to clarify a misunderstanding you and others have of me. By asking Anders what he intends to do about his views, I am not disagreeing, questioning his motives nor being childish. I am telling him that continuing down the path would make me question motives though. I am being quite serious about that question.
Let me add details to my prior story which you found interesting…
Before getting the advice from my friendly corporate counsel, I asked him if I could get his legal opinion on a personal issue. He replied “That depends” I, of course followed with “That depends on what?”
His reply, “On whether your story is interesting. I am always interested in an interesting case, but my advice may be to get the right counsel.”
If you knew me personally, you would not be surprised at all by this next bit. I make it a point to get to know my legal advisors. Once I know them, I do have a test question that I ask.
But first, I start by telling them I once got some amazing personal legal advice from a corporate counsel colleague. Part 1 of test… Do they ask me about that story. If not, you are placed in one bucket. If so, I tell them the story but stop before I tell them the advice. They always ask, what was the advice and I always say “I will tell you, but first I am interested in what your advice would be?” ALWAYS
That is the real test because a true attorney ALWAYS takes up that challenge, and they stop and they think before answering…ALWAYS and the sample is quite large…ALWAYS.
Now you may understand me a little bit better…the true me, not MI Dendream nor WI Dendream.
Hi Masterblaster (Any relation to Front 242?),
Sorry for the delay…haven’t had time to read and respond to any replies. I wouldn’t count AACR out but my money is on Neurooncology. People are hoping for NEJM, but I don’t have faith in the predictability of their decision-making. That is a very risky move unless they got feedback on the JTM article that encouraged final results. I don’t think anyone but Europeans really consider Lancet, not a knock on the journal but not American either. USA all the way is how we Americans think, even the transplants.
Neurooncology is my guess and I am sticking to it. Go where LL has sway. That is what I would do.
Can you post a link? I welcome the education
I don’t disagree that the situation with regards to Advent deserves more transparency. I don’t know whether any laws have been broken. Others here are more knowledgeable on that topic.
Allow me to share a story..
A few years ago, I had a property dispute with a neighbor at our second home. I hired an attorney, got advice, and informed my neighbor that the appropriate venue to settle our dispute was the court of law, not my beach in front of my children. If they continued down their current path, I would get a restraining order against them. I also informed them that I welcomed any suit they wished to file and that my countersuit could be quite painful for them to swallow should my opinion be correct in the eyes of the court. They chose to walk away angry. Then they foreclosed and a new owner was about to take possession. Before taking possession, however, they raised the same issue which the title company would not close until settled. I did not wish to spend more money on attorney fees, so I asked my corporate counsel (not real estate trained) for advice. The advice I was given was to write a letter, detailing my position and at the bottom copy a BS name with credentials “attorney at law.” This let them know, I was serious, I had a good case, and I would take action. Result, they dropped their issue and actually clarified the dispute in my favor on their deed.
My point is that my opinion was worthless without action. Since my opinion had strong merit, it only took a threat and the appearance of further action to make things happen.
Certainly everyone is entitled to an opinion. There are many people who have the opinion that the COVID vaccine is too risky. By sharing this opinion over and over again on Fox or social media, they harm society, and…
They are wrong.
We are responsible for the outcome of our actions.
Somebody probably posted this already, but just in case
https://clincancerres.aacrjournals.org/content/early/2021/09/24/1078-0432.CCR-21-2681.long
Doc, Even if we have the conviction to hold the line at $5 and just not sell, the demand to get into NWBO at $5 when it will be said to cure 1/3 of patients with the most aggressive and deadly cancer known to humankind, we will see lift off. Sha sha sha…short squeeze!
It doesn’t even take as big a short position as people think exists. Here in lies the advantage to 15K shareholders, if we think like our friend Spartan and hold the line, FOMO will drive us to the Moon.