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Biosect, if it is the idea that tumors injected with direct appeared to grow is what you are questioning, he is absolutely accurate. That was the point of the two posters and images.
What they showed was that images that first appeared to show tumor growth, were actually swollen from inflammatory cells bombarding the tissue. As I recall, the images shown demonstrated substantial fluid increase within the tumor and biopsy proved the tissue was necrotic and an enormous volume of T-cells and Macrophages had overcome the tumor micro environment to penetrate within and throughout the tumor as well as in metastatic sites.
I found a charger and am trying to boot up the first gen Ipad, but the battery is very slowly gaining juice. I hope that I can recall my passcode. Then, I need to figure out how to post an image because I have tried many times but for some reason have never been successful. Maybe I can email it to a friend that is more tech savvy and they can post. All this assumes that I can get in and I do have the posters in question, but I am fairly sure that I do.
I would not be surprised if Doclogic, Flipper or Senti beat me to the punch. I was just a lurker back then, but there was another board historian at the time whose name is currently blanking on me. Someone has these posters.
I can’t dig up the poster itself, but I will never forget the images that I saw when I read the poster on the one Ovarian cancer patient who despite only injecting the primary tumor saw most all the metastatic tumors shrink away. The images of the necrotic tissue within the large primary tumor were quite impressive as well as the disappearing tumors. I think I may have the poster saved on my old Ipad if I can power it up.
If one recalls, it was the Direct data and presentations that propelled the stock to double digit stock price, not the DCVax-L trial.
https://www.prnewswire.com/news-releases/nw-bio-making-a-joint-poster-presentation-on-its-dcvax-direct-trial-at-the-29th-annual-sitc-meeting-281912681.html
If grapefruit juice could do that, there would be hundreds a Florida farmer billionaires right now.
It can’t
I have really enjoyed the dialogue with you too ChiU.
I don’t really deserve much of the credit. I just like to twist words, but there are so many good people here that have helped us all stay sane when it seemed like staying invested here was insanity.
Where would we be without the DD from Senti, DocLogic, Flipper, Lykiri, IkeEsq, Dr. Bala, Hmuney, DD and so so many more. I can tell you where I would be…
Many years away from retirement instead of just a few months.
What they really need, is just a little room to breath
In the corner there’s another one
Reaching out a hand coming from a broken man
You try to live, but he’s done trying
Not dead yet, but definitely dying
With the rest of the clowns yea yea
One side…Hefty, Hefty, Hefty
The other…Wimpy, Wimpy, Wimpy
My advice, Always choose Hefty Garbage Bags to take out your trash
I like the way you think Doc, lets turn it up to ELEVEN
Doc, I am not following, sorry.
But a very good night to you tonight and many nights to come.
You are the woman, Senti!
This fraud has lost all credibility under his pseudonyms, so he was hoping newbies would bow to the swamp rat himself.
No one buys any of this garbage anymore. Unfortunately, the broader market hasn’t realized the snake that he is. We will need to fight the likes of him post-approval.
Well, maybe OIG will solve that problem for us.
Hi DMB, We can be certain that they submitted the SAP to FDA and it was not rejected. Chiugray did a nice job transcibing for you.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168266043
This per company guidance occurred and had to occur before data lock. I guess we really can’t be certain they submitted. By what rational explanation would cause them to wait after building and validating the ECA model and receiving SAP “approval”. Now, perhaps FDA has been back and forth regarding the ECA and exact statistical analysis, but this would occur after submission and it is crazy talk to think they would wait a year to submit (the model was first presented in April 21). Maybe FDA just decided on a whim to look at the use of ECAs and publish in Annals of oncology and maybe it has nothing to do with DCVax.
It is actually quite a leap of faith to believe they have not submitted when all signs show that they have.
Nice work Fireman. Why would anyone believe anything posted by that guy anywhere?
Gary, I think that is a misread. I think they are saying you can’t preview any information before it gets presented in the scientific session. You can’t present data in the scientific session that is previously published without adding meaningfully new data. I am pretty sure you can present data in an industry theater (I don’t know ASCO like I know other conferences) that has been published elsewhere, but a phone call could answer that question for certain.
Thanks Doc.
No one really got that my period of fury and anger was manufactured. Even my friends got angry with me. I went all in, but I was making a “Modest Proposal”. I painted half the case for a criminal conspiracy only to do an about face and show everyone how ludicrous that path was. It is all predicated on Dr. Linda Liau, UCLA, Dr. Keymours Ashkan and King’s Hospital all participating and thus criminals themselves. That is the thing about a criminal conspiracy, all conspirators are guilty if anyone in the conspiracy is found guilty of a crime.
Ludicrous
And I AM SICK (literally) AND TIRED (crazy fatigue) OF THE RESIDENT BAND OF BOZOS DRAGGING DR. LINDA LIAU’S GOOD NAME THROUGH THE MUD.
She is the PI, it is her study and her drug. She presented the ECA validatIon and the SAP outline. She helped develop those things. To bash the study is to bash her.
Anyone who thinks this is a fraud is a fraud themselves.
Good People Know Right From Wrong.
Ask yourself, which side is filled with good people and which is not?
Can you make minor modifications to a patented process using mostly the same process without infringing on the patent?
I am no expert, but this sounds like flimsy rationale
Jondo, while true that the industry theaters are not part of the scientific session, they are not a free for all. ASCO must approve the content and the content must comply with regulations. Last time they used this pathway they were not amidst a regulatory process. This time they are. The rules get enforced once you get to that stage.
Captain, it was may plan to plot monthly or weekly share increases against stock price to see how much impact the increases had on price. I just don’t have the time.
My gut tells me the two don’t correlate and friendlies have not dumped shares, but I am curious. For example, in the past two months, 20 million new shares and price is up 30-40%.
Something tells me Cofer has been watching these dynamics very closely.
Gary, I think your theory is highly likely. Even humble people want the respect of their peers. All these shorty mudslingers act like they are attacking Linda Powers, but in actuality most of their criticism is pointed directly at Dr. Linda Liau….
SHAMEFUL
Ike, you are being generous. Good news doesn’t maintain the price here, it drops it. If clintrials were updated, we would probably be worth 2 bits to ensure no new funding.
Yep Gary and that near 30% survival included all those placebos that passed away before they had a chance.
If you take the last 108, they appear to have 38.5% 3 year survival. I would have to look back, but at the time I validated this with two other methods (close guesstimates) and came up with 35% one way and 40ish% the other.
We will see close to 40% 3 year survival and over 20% 7 year survival. 1 in 5 are cured, 0 in 5 with SOC only can say that
Goat serum is cheap too. And lots of people think it is a cure all as well. It isn’t. It can be flat out deadly.
Do you ever attend scientific conferences?
People study generic drugs outside indication all the flipping time. Like every conference has phase 2/3 reports. Take your conspiracy BS to Facebook where it belongs.
Data lock occurred after the SAP was finalized., meaning broad strokes were generally agreed upon but details matter in statistical analysis and many sensitivity analysis may be needed before landing.
That occurred on or before 10/5/20, over a year and a half ago.
I think it is silly to believe they haven’t. You see the steps made in UK. Do those look like the actions of a company sitting on their thumbs?
Gary, to your earlier post. I don’t think they were waiting on 248 deaths. What I was saying is that reaching 248 PFS events took substantially longer than anticipated (i.e, efficacy) but the powering to detect it was destroyed so LP marched on. Then we thought reaching 233 deaths was right around the corner, it wasn’t. It took a year and a half to reach, despite earlier data presented by Marnix, except that the first time they said 100 alive, they didn’t account for LTFU. This drug works really well and that is evident in the very long fat tail. As she continued to wait, it just got longer and fatter because the last 1/3 patients were nearly all treated, some at entry, others a few months delayed but before progression. There are no questions of efficacy. The outstanding question is how to establish a relatively uniform Synthetic control arm policy.
I just need us to get the answers soon. No one is getting any younger around here and I could use the pick me up right now.
One article on the study and results, another article on the validation of the Synthetic control arm.
Thanks Hoffman. Cheers to you and us all (longs I mean) as we reflect upon the new day born on Easter Sunday.
It is never too late to start the day over.
It is never too late to hang your head down on my shoulders
It is never too late to come on home.
We have the ability to start fresh an choose the book that we write for ourselves. That is the message of Easter and is a good one whether you are Christian or not.
It seems Joan and I are in agreement.
A company submits a label, sees comments by 30 days, responding to those comments can be substantial effort and compromise, then a company resubmits label with supporting response, by 30 days FDA returns with comments. Companies can fold or try again.
Companies know the basics of their label well in advance of getting a label. Companies that get very difficult responses for good reason are the ones waiting on pins and needles as to whether it will be thumbs up or down. Most know the outcome but can’t say.
Some people in some companies are privy to some of these deliberations. The list is controlled, but not as controlled as you might think. The fear of God is placed on anyone with any knowledge. They are forced to sign a very threatening non-disclosure which very clearly remind them what constitutes insider trading. People think leaks happen…they don’t.
I speak from experience. My faith is placed in Dr. Linda Liau. Complete faith as she has shown us her soul. I believe in Linda Powers. She has been David leading a small force against Goliath and his army. She has gotten us to the end without going under and actually stronger than ever. I believe in Sashi Murthy and recognize that he was the secret to finding the Great Glass Elevator, and all or our chocolate and fizzy lifting drink Dendreams will come true. I believe in Marnix Bosch. He is smart and has guided the ship through regulatory waters unknown. He is Leif Erickson landing on North America long before anyone else from Europe would.
I speculate. I defend my theories. I share my equations and analysis freely. I am not paid by anyone for anything about this stock or any stock. I am not your financial anything. Make your own financial decisions or seek licensed professional help. I am not your anything, clinician, therapist, attorney, or anything else. I am not offering anyone here any advice, I am emptying my brain of thoughts in mostly stream of consciousness. I am hiding behind an avatar. You should not trust everything you read on this blog. You should do your own due diligence or seek licensed professional support, and make your own decisions about this stock or any other stock.
A company waiting on a regulator that gave them the green light to premarket promote and therefore went dark on everything else that even sniffs of breaching a mandatory quite period, one that pulls it’s booths once the Branded Advertisement begins but now has a giant booth and Promotional Product Theater knows the answer before it comes. They can release a paper before they get their answer from he regulator, whichever they may be.
Intellia has one gene editing therapy in humans. They also have a pieline, but are using an inferior technology. Yet, one dose in one human jumped them to $5B MC, and short term safety reported in 3 patients propelled them to $12B. Gene editing has great promise. It also has great competition and anyone using CRISPR/TALEN has limitations on which genetic diseases are in play.
This company is on the verge of an instant $5B in revenue for GBM practically overnight. This alone deserves a $20B MC upon approval. Factor in pipeline and you should see the market go absolutely bananas over DCVax.
Moderna’s $7B in revenue commands $66B MC and because of the promise of their pipeline once reached $150B. They have a good pipeline, ours is substantially better. No one paid attention before COVID.
If you follow how biotech’s spike before landing in reality of the moment, they usually go about 3x higher, that means NWBO has the potential to make me and my cabal able to make a big, big move into a company next time. A $66B MC is about $56 per share fully diluted to the shelf.
When they expand into sarcoma and colon cancer, it could go Tesla big. That is not crazy talk. Linda may decide to buy any other assets she wants and even BP may not be able to compete for bidding.
Hard to believe, but possible in the short term.
This is why the shorts are crapping their pants.
I agree with you on everything except the tone directed at FDA.
FDA has the safety of the American people to protect and precedent is precedent. They move slow in order to get things right. They are underfunded and overworked and it is COVID.
I will not disparage FDA. We need regulators. To protect us from scam artists like people who sell goat serum infusions for automimmune diseases, I prefer them to make sure the ground rules are in good shape before proceeding with what could be the most significant drug approval in the history of the agency.
They are well aware of the potential for this product, it will create a new term Mega Blockbuster or Rocketbuster because a blockbuster drug is small potatoes as compared to DCVax.
They need to get things right, especially after Aduhelm blew up in their faces when they were trying to do what was best for patients.
They do not need to be informed, they were adequately consented. Physicians should not be informed, they are to stay blind to protect the intetegrity of the trial. The point of maintaining a blind is to maintain the BLIND.
FDA does work directly with CROs sometimes.
You speak from your opinion, I speak from experience.
I am stating a theory that has not been disproven, A theory that completely fits every picture including validating the about 38% progressed number with three different ways to analyze the data which I previously posted and you could not refute.
I have beaten you by quoting regulation and law, once embarrassing you while attorneys on the board called victory for MI Dendream. Then you disappeared and never responded to me.
The blind is executed by the CRO, not the enrolling or evaluating physicians as you contend. Physicians actually do not know when they progress whether or not they had been on placebo and NEITHER DOES ThE COMPANY. Both are blind… that is what blind means. How do they execute a trial and stay blind…a CRO keeps the blind.
No more placebo means no more placebo. It is not ethical to commit a patient to death. Halt was recommended, but company chose to proceed.
You have no idea how censored but not progressed patients get handled. It presents quite the dilemma. But you do know that they stay in the combined OS KM curve. It is what you do about separating them. Isn’t it curios that PFS was not addressed in any of the refresh data release?
How do you protect patients from potentially unnecessary morbidity and mortality, and at the same time deal with the fact that ITT has a knowingly and deliberately tainted population, and per protocal eliminates many patients thus destroying power. Perhaps, you consider an external control or a hybrid external control. Hmmmm….
Patients consented to knowing they may receive active treatment that is why they entered the study. Hoping to be randomized to DCVax. They understand that per study they may receive treatment. No new consent required.
PFS was monitored in aggregate as far as any of us know. I have not seen KM analysis of Progression. If they did not progress after receiving DCVax or progressed slowlly, it is likely One reason it took so damn long to reash 248 events. KMs seen are Just for survival which was grouped. However, since we received two points in time, it can be analyzed to demonstrate 3 year survival in a cohort of about 100 patients treated with DCVax before progression. This comes to about 38% 3 year survival and about 21-24% 7 year survival in treated patients.
Officially, NWBO does not know the placebo cohort was destroyed, at least before SAP was NOT REJECTED BY FDA, that is as close to approved as you can get from FDA. This is why they cannot update US Clin Trials.gov.
FDA has published a viewpoint on ECA and HCAs.
I clicked back, and am wasting time here but so be it.
The placebo arm was destroyed in multiple ways by regulator edict in my opinion based on numerous facts lining up to produce only one plausible conclusion. You have tried, others have tried but no one has another rational explanation that cannot be and if I read it was blown to smithereens, likely if I didn’t Biosect did.
First all patients in screening at the time of the halt were placed on treatment as placebo was no longer ethical (see also Geneva Convention). Next, if placebo is no longer ethical, the placebo being removed means that original placbos who had not evented were moved to treatment with DCVax. Finally the reduction in power caused by this has dramatic effect on the ability to show statistical difference even though it means all patients in the unadulterated placebo arm either evented and then moved to DCVax or evented and died. Only 3 patients even got resected a 2nd time.
Regulators did this to the trial, a trial in a rare disease which is universally fatal and has predictable deterioration in morbity leading to mortality. While this is usually adult onset and a malignancy, it has similar issues to Muscular Dystrophy. Zolgensma was approved with a single arm study in a handful of kids.
I dunno, I stole this from an interpretation of Pigs in Zen.
“ You meet a person and they feel, for some reason, that they are bigger than you and their thoughts and opinions matter more than yours and they're all wrapped up in their ego and they think they know everything (I know about pain and suffering and being cold) but they have nothing to back it up so they just play it off like they know what they're talking about. While at the same time you know what's up and you know a faker when you see one and you expose them, in your head. ”
I agree with you Captain Obvious, that is why I used future tense.
But, this year ASCO is feeling so damn right for a great time to celebrate. And, you by the way are invited to join me, my dad (my mom doesn’t drink), my family, and my Arizona friend, my dear Spartan friend, my brilliant Philly friend, my Jeep enthusiast friend, my Hockey dad friend, and my message board friends when we pop open $1500 bottles of wine to toast just because we can.
https://www.thehouseofglunz.com/
I will ask my Sparty Friend to book us a suite at someplace in the Loop and we can have our celebration. I think Linda is going to be giving us time to plan as well. She is a kind, thoughtful person and she can obviously lay down a network of tracks so wide and far that I think she can plan to give us time to plan.
And your welcome for the free advertisement, House OG.
When the levee breaks…WE ARE GOING TO CHICAGO… and they are going down, going down yall, going down.
If and When…Get there, CHICAGO… SOUTHSIDE BABY!
McCormick Place
(312) 791-7000
DMB2, I agree with Danish Dude’s view on timing of data release…
Top line data is neither late or early, it arrives when it is meant to arrive. The data hasn’t been “ready “ because the regulators had work to do.
There have always been two sets of justice in the US, one path for haves’s and a lesser path for have nots.
I know that Spades are the swords of a soldier (see also Ex, LC2020, and crew)
I know that Clubs are weapons of war (see also Cofer Black)
I know that Diamonds make money for this art
But that is not the shape of My Heart
DMB2 thanks for the support. I always appreciate another experienced eye weighing in. We all have doubts, but we find strength in each other.
I knew I was putting myself out there with the tote bag, but when the ABTA full page advertisement was shown to me which has now been altered to a half page advertisement, my doubts were eliminated. I forget who dropped that bombshell in my lap, but thank you! There is no doubt, the ABTA branded, and hardly unbranded advertisements constitute premarket promotion in my opinion. But they followed the Name, disease state and MOA path, not the “coming soon” path.
My flaw was believing the very conservative viewpoint that 6 months rule applies to both. I now agree with the view that it only applies to the second pathway. Given what we now know about outstanding steps, path 2 was probably not even an option for them when they received a “green light.”
DD, it is quite interesting that they swapped Opdivo and Keytruda.
I am wishing for a bidding war, but I will settle for Merck.
PGSD, Thanks for adding a new pump song to my morning pick me up.
I really like that I will be able to say “we” in a true statement about an historical victory and I can include myself with people like Dr. Linda Liau, Dr. Keymours Ashkan, Dr. Tomothy Cloughesy, Dr. Marnix Bosch, Dr. Sashi Murthy, Michael Biggers, Carl Rago, Gary “skitahoe”, Cofer Black, and of course Linda Powers.
We beat some really powerful people. My role was very small, but we did this …together.
David once again kills Goliath
Available in both In Ruby Red and Classic Yellow so that you have options to match your wardrobe
The study design receiving approval to move forward does not mean that the Statistical Analysis Plan has been agreed to, and even then as you know Biosect, no study and SAP truly gets fully approved until FDA has data in hand, plays with it themselves and they sign off on the results.
Even an SPA is non-binding
Biosect, you mean to tell me that if the news hits and we are going to see a scientific presentation at ASCO, that you are not going to be there to see it?
I like being there to see history made, or some would call this herstory.
Thanks, pgsd. Always nice to have the primary source linked for all to see.
So 4/27 is the date we find out if they are in the ASCO scientific session. Maybe, maybe not but only 11 days of uncertainty and there are only 7 trading days. If not ASCO, a paper could drop almost anytime before 6/3.
7 trading days to get in long or cover your shorts. 7 days, just 7 days.
0 days would be poetic. He rises again on Sunday, she destroys death and rises again on Monday…I don’t believe that is going to happen but boy that would that be POETIC JUSTICE. The only thing that would make that more poetic is the Department of Justice issuing indictments on Monday.
Maybe DOJ comes first? I can go for that. There is a chance that the DOJ investigation was triggered by Cofer dropping a pile of evidence in their laps. Perhaps, that is what Bigger knows.
I can’t believe they filed another frivolous lawsuit while DOJ is watching…idiots.