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Biosect, Doc… if this all happens before ASCO, I will hopefully be buying a couple really expensive, well-aged bottles of red wine from House of Glunz in Chicago to toast with you and a couple of my friends.
Thanks hmuney! There certainly is a lot of chatter being drum up over the next month and a half. One could say LL went dark for a while there but she sure doesn’t seem to be restraining herself now.
And Marnix in a promotional theater again…that sure doesn’t look like June is in the Quiet Period and possibly not May either.
Back when I was pushing my Premarket Promotion stance, a friend asked me to lock in a date and I told him April 29.
Again, for those who love to poke fun at me and the tote bag… my most recent input on the Coming Soon reg was that the 6 month rule only applies to path 2, actually saying “Coming Soon DCVax(R)-L”. The first path requires the same authorization from FDA, but it is not time bound. You see, FDA, is pretty uptight about making False or Misleading statements so the rule defines how long “soon” is. In both cases, FDA has already agreed to approval but hasn’t finished the review and label language agreement.
“Coming Soon the $10+ Million Man, Dendream” and his millionaire family and friends, many friends.
Probably the single best science fiction book ever written, Dune. But I think it also appears in each the many sequels Dune Messiah, Children of Dune, God Emperor Dune, Heretics of Dune, Chapterhouse Dune. I don’t really recall each book as well as the first.
It is the mantra of the Bene Gesserit witches and it absolutely works in real life to. Repeat it to your self over and over when you fear a situation and you will find strength.
Only one book has outsold the total series…the Bible
Thank you, Nix but I can’t take credit. Credit belongs to Frank Herbert which I assume you know
Erg, they would need to inform IRBs for any active trial and consent/reconsent patients accordingly. The trial has not failed…period.
Shorts game is to create doubt and fear, but…
I will not fear
Fear is the mindkiller
Fear is the little death that leads to total obliteration
I will face my fear
Allow it to pass over and through me
Then, I will turn my minds eye inward to see its path
Where fear has gone only I and $10 million will remain.
Hi Gary, My gut says no scientific presentation at ASCO, but that the data is still Encore. The Product Theater presentation kind of flies in the face of a quiet period, and the cash output is not insignificant. When do we see the titles?
I am thinking it is the publication before June 3rd, and hopefully corresponding approvals.
I can tell you are long which makes you a very smart person in my books, that was a warning for others. The chartists have convinced me you can predict the waves pretty accurately when the binary is in the distance.
This event is pending.
Also, KIPK these combo studies where everyone gets DCVAX but some are given add on are taking place in newly diagnosed GBM and are regulatory submitted.
The latest novel therapy pivotal trials approved to move forward by FDA are all in recurrent GBM. In terms of revenue potential, not only is that a much smaller population but you also have much shorter treatment duration potential. No one starts with the smaller subset if you can have the whole enchilada. So, they can’t have the whole enchilada because the new SOC was not available to them for trial.
Agree Biosect, I was adding to your point not disagreeing.
You present Encore data in product theaters, not data release.
But….this company is unorthodox. Regardless, I agree with you that the paper (or possibly a late breaker) comes first. I have stopped waiting for late breaker release, but a surprise there does fit the picture and plan. What can be done is you present the 15 min platform late breaker, at the end you invite them to the Product Theater for further details.
Or, you publish the data, then Encore it in the product theater breaking no embargo policies.
The short side scam thesis all hinges on Dr. Linda Liau being a criminal contributing to a conspiracy to defraud investors. Think about that for a minute.
SNO, Academy of Medicine, Mt. Sinai, Asian Americans…boy, oh boy there are a lot of smart, successful people she would have fooled into honoring her lifetime of achievement with DCVax in that case. I have looked into her eyes, seen her face, heard her speak about the value of human life…she is the real deal, not some two-bit con artist.
Who is more likely to be trying to steal your investment dollar, those Knights and that Castle or Dr. Linda Liau?
Love it!
The mother of all binary events has been brewing for almost seven years now. So, as much as I have appreciated the charting lessons, and believe me I plan to sink deep and learn more for future investments, statistical analysis falls by the wayside when a short squeeze occurs.
I would not want to be caught without my full investment at this moment in time.
NWBO has stated over and over again that there was no interim efficacy analysis performed. Period end of sentence….this is an old and tired argument.
In my experience, interim futility analysis is performed blind to treatment. Arms are separated and analyzed to see whether a statistical difference exists or with more time has a possibility of hitting. When far outside the range, studies get killed, but when just outside the range patients get added.
What NWBO has done is analyze the entire grouped cohort data. This does not destroy the blind or provide any detail regarding the likelihood of endpoints being reached. Therefore, it did not impact how they approached building the SAP. Had they done an interim, they would not have been able to redesign endpoints to account for the lack of a true placebo given halted screeners were all treated, placebos who had not evented most likely crossed over immediately and anyone else evented and either chose to cross over or not. If they stayed in trial, they likely crossed over. The LTFU, that is a different story. They likely chose death. In today’s day and age, death can later be captured so long as they died in the country of origin for the trial. LTFU dropped between refreshes from 12 to 7. Those seven may just be lost or may end up on the KM curve when found.
Just how do you catch a crook when that crook uses sophisticated weaponry to hide their illegal activity which has almost destroyed the greatest clinical invention since Spinraza or the Saulk Polio vaccine?
You get them with their pants down and no where left to hide. I have seen a lot of positive information come my way in the last year, only to see the stock dropped from $2.50 to 0.69, and I have seen this game before. A rocket ship needs fuel.
Momma’s got a squeeze box, daddy never sleeps at night….stuck in Folsom prison where time keeps moving on. They shot a gal in Bethesda, just to see her die. But that whistle kept on blowing, now they can hang their heads and cry.
ASCO is the celebration we have been awaiting…I love a good OIG foreshadow, an FDA foreshadow, many company foreshadows. Its like a B horror movie where everyone sees what is coming but the bad actors about to get axed.
Yes, a product theater is expensive. A TV Commercial is ridiculously expensive, like $30M line item expensive, but in order to increase awareness and rapidly gain market share, you spend what you need to spend.
ASCO Product theaters aren’t really for physicians, few go. The scientific session is for data release, the theater is for hype.
I love trivia like that. It is very difficult to build a levee as big as this one. When it breaks, crying won’t help them and praying won’t do them no good.
Biosect, We are Going to Chicago! I know that it has been a long time and that we have had to repeat ourselves over and over again, but I dedicate this one to BWIS, EX, LC2020, and all the rest of that crew too.
Thank you, your ability to see farther out there has always been helpful for us longs.
Lykiri, oh Lykiri where would we all be without you
Thank you yet again, but this time picture me with a big floppy hat and ridiculous feather bowing down, tipping my hat off, twirling it back around on my head and rising.
Our path forward is much clearer now and does not seem overbearing at all. The steps may have already been completed by now and submissions begun. FLASHWORKS…Flaskworks.
OMG
How can a company that has screening in a study halted treat new patients in that study and start new studies without informing IRBs of failure?
How can patients be treated with a drug known to have failed without adequately consenting them?
Answer: They can’t
To my friends ex and lc
That cool feeling of serenity when you know the answer before the market does.
You know what is hilarious…they tried the lawsuit SCHTICK again!
While the GOVERNMENT told you they are watching.
HILARIOUS
Esmo “along with prognostic and predictive biomarkers”
You can’t make this stuff up follks
To all the fools I loved before
You can keep putting words in my mouth all you want Iron Mike. COVID
The regulation is put out by FDA and enforced by FDA and OIG. 6 months is written for enforcement ability, enforcement is a choice.
What is important is that there is absolutely no question that the Branded and Unbranded advertisements in ABTA and tote bag together are a ckear example of premarket promotion AND they had no booth. Now they have a booth.
Go back to your Russian propaganda campaign all you want.
You can have more than one presentation and publication. The ECA validation is one. Deep dive into Efficacy and Safety can be separated from TLD plenary presentation during secondary platform presentations….done all of the time.
We will have data by or during ASCO IMHO. Last chance to load up.
I have not had the opportunity to listen to these presentations yet, but if LL discussed starting a new combo trial with DCVax-L, I cannot wait.
A new trial means a new patient consent, a new IRB review, as well as a new FDA regulatory review. From what the credible posters here are saying, everyone in this new trial will receive DCVax. Some people just don’t get it. How can anyone not see what is happening here.
The 2018 SNO presentation gives you a very clear picture of nearly all the first 3 years, with the exception of about 5 patients on the cusp of crossing 3 years, and several lost to follow up (LTFU). If I recall the numbers correctly, and admittedly I may be off a little here or there as it is the direction and approximate magnitude that matters here, but 3 year rates go from 3/2017 data at 25.4% and 9 or 10/2018 data at 28.2%. So he is clearly not talking about the study data for the entire population.
The increase of survival can be attributed to two very important things. First, the removal of placebo from the final 32 patients who all receieved DCVax(R)-L (you see what happens there now that it is branded). This makes the final 108 enriched with treatment, but it doesn’t stop there. Likely, when the decision to remove placebo from consideration for newly enrolled patients was made, this also meant that any patient who was currently being treated with placebo (i.e, had not yet progressed) also flipped over the Registered Trademarked DCVax-L. Thus the only placebos in that cohort are rapid progressors who die quickly. (Uh oh…what do we do now that the treatment group has delayed treatment or the placebo group has forced migration?…Uh oh, placebo was just enriched with death in the PP analysis). This makes the last 108 probably somewhere near 90% treated, essentially.
Bare in mind that the first 223 jumped almost 3% when @ 96 more are added (108 - 5 short of 3 and - 7 LTFU) giving you the first clue to treatment effect. The floor for the treatments group in the original OS analysis is about 25.4% + 1.5(3%) or 30%. There is fudge factor up and down for simplicity.
Now where things get real interesting is with the predictive statistics provide in the JTM article and the SNO presentation. Here, you see that the long fat tail flattens out substantially and when one factors in that enriched DCvax(Registered Trademarked)-L (aka BRANDED) cohort, one would expect that the BRANDED Product Cohort lifts these predictive lines upward rather significantly and those patients who are put on the Branded Product called DCVax-L which is a Personalized Immune Therapy to treat Brain tumors and has shown long tail survival through stimulating a person’s own immune dendritic cells into overcoming tumor micro environment and fighting antigens from their personal tumor LIVE LONGER LIVES (or so I am told through branded and unbranded product advertisements).
This is going to be such a fun ride Marzan. Like you, I know I spread this love around far and wide. It is going to be quite the celebration.
Stop Shorting in our financial markets.
Stop the Steal
Large, private meeting space within the booth? I thought they are in a quiet period. Who would they meet there and whatould they talk about?
I am no expert here for sure, but seems to me a quiet period means that a company does not discuss data on their product at all. Should past data give an impression that is inconsistent with currently known data, that could be very problematic for them.
Did he present any clinical data?
Curious to hear the argument about how a Commercial, Promotional Booth fits into the idea of a quiet period. Maybe they plan to put duct tape over their mouths while they greet physicians who come asking them about DCVax.
Maybe they will hold up giant placards that say things like “Quiet Please - No Speaking Allowed within 10 feet of this booth”, “Nothing to See Here, We are a Scam,” “Grapefruit Juice for sale - Go see Dr. Askan in London and bring $180k for the best bags of grapefruit juice in the world”
Yep, she probably owns the Ad Agency and Booth build company NWBO employs as well. She is probably planning to pack sandwiches and sell them to her team covering the booth rather than let them walk to the food court next door. I mean anywhere she can grab a few bucks more after cost, that is what motivates LP. Lets look for everywhere she can scam a buck. Stop looking for bread crumbs and look for peanut shells.
In my experience, when people have enormous wealth, they avoid the big payout opportunity and go for peanuts every time.
Unfortunately, Viking we beat scotty and BWIS to the punch. What will they have to say now?
Well, I won’t know because I ignore that member.
Shipping, storing and assembling a booth costs $$$, especially in Chicago where your choice is our Union contractor or our Union contractor, sorry not your vendor.
Looking forward to perhaps meeting some of you. I probably need confirmation first though, which I expect to get
Y’all heard this one many times…an Ode to LL, now and Cornell to Mt.Sinai.
It is a repeat, but I love this Ode to LP
Yes, I had not taken note of the Autologous PBMC written after placebo before. Thanks for clarifying.