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Better yet, be quiet and lay low until the study hand delivers a high powered rifle and that bear stands no chance.
When you are being attacked by a bear, it is best to play dead. I think NWBOs management has learned that lesson very well.
Who wants to be hooked up to an electric device forever? Yes, when the alternative is death. No, when the alternative is DCVax.
Well stated. I think there are lots of factors at play here. I hope your ship floats instead of sinking.
Imaging tissues used to be enough. With checkpoint inhibitors, they need a way to image and distinguish physiological processes. That takes time, can be invasive, and is expensive. But as they get more experience with these immunotherapy mechanisms, there will be solutions.
I couldn’t help but wonder if they’ll have to balance checkpoint inhibitors with immunosuppression to avoid symptomatic inflammatory responses. Are these vaccines working too fast and furious?
I have some experience in the imaging space. I’ve seen more than my share of PET scans, MRs, and CTs.
I heard those are exponentially more expensive than a PET scan :)
They’re still expensive. Lots of factors going into them. Cost of FDG, cost of the scanners, and the cost of the staffing them. But the more scans that can be done in a day, the more the cost should come down.
Cost of scintillation detection and computer processing has directly affected PET imaging cost. Reconstruction takes 1/5 the time it used to. Time is money when a patient is on the table.
No doubt. With reactions that pressure the corpus callosum, combo trials could put harbor negative reactions and symptoms that make preventative measures necessary.
After seeing that last slide on reaction to checkpoint inhibitors and hearing the issues with symptoms, I couldn’t help but wonder if that was the reason for the FDA hold. However, the slide also seemed to show how powerful these checkpoint inhibitor immunotherapies could be.
Meaning....they didn’t know how much of a home run they’d hit. And how could they? They’re blinded.
The finish to this story could be gripping. If so, hold onto your shares and make the squeeze a fun one.
Thanks for clarifying. It’s going to be fun to unblind this spring.
Censoring....
Anyone care to comment on data censoring in the P3 trial? With patients like Nate out there still alive 6+ years after treatment, how will the mOS data be skewed if they are censored from the results because they are living too long? Will the FDA consider the % of patient’s censored from the data due to long survival? Those seem to be key questions here...
Yup. That’s what happens when you’re demonstrating efficacy against an orphan disease. The sooner the ending, the worse the results.
Flipper is right. The survival curve has two axes and each is meaningful. The “tail” means that there could be 20-30% of these patients that are effectively cured. Surviving 5 years or longer with no sign of disease is the “cure” standard in cancer care. The initial slope being pushed out to the right is the percentage of patients seeing a response due to the vaccine. People who historically would live 8 months now living 14-16 months. While I’m hopeful for the initial slope, I’m really excited about the tail. GBM has been known as an orphan disease and DCVAX could potentially change that for 1/4 to 1/3 of all patients. Would be a Gamechanger. And if this mechanism works on GBM (one of the hardest to treat cancers), why can’t it work on others?
The answer is that it could...
The alpha puppy’s model is pretty good. Very conservative, but still demonstrates efficacy.
Your wife is right on everything, except that Woodford hasn’t sold his shares.
P3...that’s the make or break here.
That’s good stuff to talk about.
The big questions...
Let's play optimist again here. Blinded results come out and show serious potential efficacy with DCVAX-L. What comes next?
Unblind the P3 study, publish the results, and get FDA approval? Can FDA approval come prior to unblinding? Will a new right to try law impact commercialization?
Also, will there be enough capitalization to get to full DCVAX L commercialization? The last round of dilution wasn't pretty, but with a rise in price, warrant money could start flowing in and fund the final road. Commercialization would provide income to fund combo trials and a P3 for Direct. Serious buyout offers would start rolling in. If DC Direct demonstrates efficacy, then we're in serious business. Buyout offers at that point could be staggering, or commercialization of Direct probably puts this on par with Big Pharma. Think $100 billion market cap.
The platform of their product is what is exciting. It should be potentially terrifying to chemo makers.
Clearly AF is getting desperate for bankruptcy on NWBO. What kind of "journalist" roots for bankruptcy in a company actively sponsoring a blinded trial with the potential to be a major inroad against an orphan disease?
Let the science do the talking AF. He knows less than the doctors involved in the trial. But he seems to be rooting for somebody.
Speak softly and carry a big stick. The trial results will speak for themselves and the company should remain quiet until they do. Depending on how positive the results are, AF and his cohorts could be in for quite the spanking...
I agree. The longer you wait to unblind, the longer the tail, and potentially the longer the shelf life of the product. The company has to consider unknown subsequent technologies as competition. If approval and commercialization can be gotten from blinded data, then they should wait as long as possible to unblind. IMO
The best thing they can do is to say nothing until data is published. "Anything you say can and will be used against you". Like Cofer said, the forces working against them are powerful. Keep quiet and let the publication and results speak for themselves. If they're good, this thing takes off. If not...bankruptcy is imminent.
The ASM was great insight into their processes. I felt they were very open with how they got the data they released at ASCO last year and the work and expense that it took to get that data. Publish the blinded data and work toward FDA approval with that. In the spring, unblind the trial and start working toward that final paper and commercialization. Then go forward with combo trials and Direct trials.
I felt the information given at the ASM was somewhat revealing into the company's process of getting blinded data (the limited data they revealed in June) and the reveal of journal submission this past fall.
I agree, no worries. I am long and I am hopeful for those with a GBM diagnosis. My concerns are more about approval timelines and commercialization. NWBO seems to really be going it alone in this adventure.
Something started in the fall. Right about the time that blinded data was submitted for journal publication. Coincidence?
Do these scientists make their disclosures before or after they read the journal submission. Do their close friends, family, lovers, poker buddies, and other people that they share information with when they've had too much to drink at Thanksgiving disclose their financial interests??
My point is...a development of this proportion doesn't stay hidden for very long.
Actually, the ride has been pretty fun. My experience has been shorter and less dramatic than N Woodford's and other long term longs. The ending may be a dream and reality could be far different, but the ride has been interesting.
Still - why the mid Nov. bump? What's in that journal submission?
Personally, I think the late Don Knotts would have been perfect for this role...
After reading comments regarding the ASM...
A breakout of this stock from the 0.16-0.18 level occurred around Nov 15th. At the ASM, it was shared that the blinded data journal submission happened sometime this past fall with 65 co-authors. So there are 65 people who have access to this peer submitted journal data with no restrictions on trading in this company. So why did a breakout occur on Nov. 15th? I'd bet there are 65 scientist physicians who know why and a few others who are peer reviewing the submission who know why too.
There are so many dynamics in play with this equity and sometimes this investment feels like the makings of a good novel. You've got the people researching a new method to cure cancer, the people trying to make loads of money betting on the scientific failure, the reporters, the early investors, the late investors, the Twitter squawkers, and the legendary Cofer Black on the board of directors investigating. All we need is a happy ending here. It goes like this:
Great P3 results and DCVAX making inroads against one of the most lethal forms of cancer, the hedge funds getting prosecuted by the SEC for illegal naked shorting and paying billions in fines, and a share price rise that rewards the capitalists that hung in there for the duration. Who's going to write this book and which villain actor will portray Adam Feuerstein in the movie?
I'm enjoying the ride here...
Actually, if we get to $0.50-$1.00, there will be significant warrant money rolling to fund new approvals. They won't need more dilutions...
Smith's article highlights an interesting point made by the neurooncologist at King's College...
GBM is heterogeneous and whole tumor lysate allows the DCVAX to target multiple antigens. It may turn out that the reason this isn't a full cure for GBM is because the disease has SO many heterogeneous "fingers" into other brain tissue. The surgeon may only be able to get representative lysate for such a heterogeneous disease in only 30-40% of cases. For those who have a representative lysate, DCVAX could be the long term solution. For those without, they may benefit from a combo therapy or maybe even a second resection attempt and new lysate vaccination to get the proper antigens.
Just a hypothesis for a second study if the P3 is a resounding success and that tail is long. Wouldn't it be great those 2 mOS events they were waiting on in June didn't finally come until December?
I think you may be correct. I might have missed the option amounts. $273 million in warrant money might be needed for commercialization and the move forward on DC Direct. Hopefully at that point, this is moving toward being a $5 billion company.
From the latest 8K was stated twice...2)and 4)
I checked the share count. Seems the 173 million shares from the latest 8K were double counted. We're still under a billion shares with warrants expiring at an unknown pace...much like GBM patients on DCVax L until that blinded data is released.
I thought the 8K from 12/31/17 was interesting. Not much capital raised through the preferred A and Bs. BUT, much of it was used to retire debt with Cognate. Now keep in mind that LP owns Cognate. Why would she take all those preferred shares, which come with time selling restrictions and warrant coverage and may turn out to be worthless, if she knew or had serious doubts about the data? If the P3 is successful, Cognate just hit the jackpot on the preferred offerings.
We can speculate all about Bigger and his NDA. But really the issue is the P3 data. If LP knows anything negative about the data, she just did herself a huge disservice by taking preferred shares rather than having Cognate cash out with the recent capital raised.
Just IMO...
Reg D offering
According to the 8-K, only 381K shares of the preferred B were sold. While that limits the dilution at these prices, I think it speaks more to the fact that investors want to see data before they plow more money into NWBO. Hopefully we'll have a publication soon.
I completely agree that not understanding pseudo progression was likely the cause of the hold. This was the subject of a talk at ASTRO this year. Unlike chemo, immunotherapy triggers a response that can easily be mistaken for progression, but in immunotherapy, this "progression" slowly fades and the response to the therapy really shows up in a few months after the initial pseudo progression. I think once the FDA understood this, they agreed to lift the hold. However, only until the data is unblinded will we know how effective the trial is for OS and PFS. Cheers to hopefully positive data in 2018!
She just got $12 million through a financing. Couldn't she have used some of that to pay Cognate if she knew that she wasn't going to get cash? Any why is Cognate hiring?
Why would LP take a bunch of NWBO shares for her privately held Cognate business if she knew that she was about to release bad data that would make the share price tank when the study data about DCVAX was released? I either think she doesn't know about the study data or she is pretty optimistic about it.
No volume to cover here at .28. Good news could squeeze them really badly...