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Wow IkeEsq...your court reporting skills are top notch. Thank you for your transcription and for giving us an ear into the ASM (I really wanted to go, but couldn’t). I continue to be impressed by your report.
It seems that management is encouraged and united to see this trial to completion and is more hopeful than ever that positive data will lead to an unprecedented turnaround. I give them praise for their work, but it pales in comparison to how they will be rewarded financially if they see DCVAX-L through to revenue generation. Anybody that can’t find value in this security at less than $3-$5 per share with the data they’ve released and their position in relation to the trial’s finish line just has their head in the sand. They correctly implied that the science here transcends a large percentage of cancer treatment revenue and potentially threatens a $100 billion dollar a year plus industry. As we find out how impactful the science is on one of the most heterogenous and hardest to treat cancers, I expect a reset in market capitalization. 250 million could easily approach $100 billion or more in 15 years, as the science becomes more well understood and revenues reflect the benefit to patients.
My biggest fear with this security is that I am going to sell too soon and one day have to tell my grandchildren...once upon a time, I held many hundreds of thousands of shares of Northwest Biotherapeutics. Man...I wish I still had those today.
GLTA
I could be wrong too.
Today is not the big day...
Well stated Gary. The beauty of DCVax isn’t just the survival. It’s the complete absence of side effects. In cancer care, the biggest part of the care is managing the nasty, poisonous side effects. I love how that part goes away with DCVax...
Lastly, when the patient crosses over due to progression, once they crossover, does their new survival become a reflection of the drug’s effectiveness? Or does their prognosis worsen and the vaccine’s effectiveness become compromised because they’ve already progressed?
All of the answers to these questions come with the data. We’re all blinded right now...even Les.
I think crossover is an issue because sorting out progression from psuedoprogression is difficult. Say a patient progresses, so they’re placed into the crossover. But now they keep progressing. What is their PFS? What if now with that they’re in crossover, their progression is now psuedoprogression? How does the company measure that? At what point did progression stop and the psuedoprogression begin? Does psuedoprogression now count towards PFS in the crossover arm?
The PFS endpoint is complicated with psuedoprogression notes in this trial and the crossover arm. I think that’s what Les was referring to.
Don’t be so sure....as the price has cratered and the rhetoric has amped up, they may be slowly acquiring on the down love....
Sounds fairly accurate. It would also explain why Dr. Liau was saying that the chosen endpoints of the trial might not be appropriate...
Sorting progression out may be difficult. But survival data is gonna be undeniable. Management was smart to listen to their scientists.
We don’t really have an “opponent”. What we have is a security that may be extremely misvalued, depending on the results of a late P3 clinical trial and the potential to turn the results of that trial into a marketable and profitable product line.
Any “opponent” would be a financial institution that might be using illegal methods to artificially manipulate the price of a publicly traded security, including ours. I believe yours and divers conversation spoke to the fact that it probably happens with great frequency on Wall St. Whether or not it is happening with this security and whether or not such activity will be unearthed remains to be seen.
The punches from here on out should be all be blindsided. You can’t telegraph your actions to a lawless opponent with no integrity. Cocaine and booze are lesser drugs, but money is the ultimate one.
The science here will speak for itself. I hope Cofer gets his highs on putting financial criminals behind bars. It’s a form of thievery and the US should hang em high.
Standard of Care is about to change for GBM...
Keep in mind that the patient population for that device is already limited to those with the strength to handle and wear it. You could consider that a form of bias in the clinical study. There was also no placebo or control group with a placebo device. They compared their population to historical standard of care.
Either way, our blended group is doing better that their study’s treatment group. Unblinding will give us the reason for the remarkable performance of patients in this study. It all comes to fruition this year.
I agree. The buzz is with NWBO. DCVAX is a buzz worthy topic. Just wait until news hits...
I debated long and hard about my proxy vote on issue #3...stock options to Cofer.
I really want to believe that he is working stealthy and silently in the background to uncover a massive fraudulent naked short attack against the company. I really want to believe that he has the leverage and the contacts within our government to investigate and present evidence of wrongdoing to the SEC that will end this sort of manipulation, not just against NWBO, but against many microcap biotechs that suffer from the same short selling tactics. I’m sure this work would take time and resources that would be worth pursuing from our government.
I also really want to believe that corruption and big money can’t buy government influence. But I’m also too old and experienced to be that naive. I’ve watched too many episodes of House of Cards and seen too many mob movies. Money buys power and corrupts people. There’s far more money in big pharma than in illegal drugs.
I can’t help but think that Cofer is overmatched here. Putting him on the board was the equivalent of sending in a single DEA agent to take down a cartel. I just don’t see it happening and I’m not sure that failure to expose these fraudulent tactics would be his fault. He’s just one guy who no longer works in law enforcement. Why should we even have him investigating something that is the responsibility of the US government to enforce?
With all that in mind, I voted no on #3. I hope he finds something and puts a huge dent in the practice of naked shorting. If that happens, the government should reward him profoundly, not us shareholders.
Of course she did. I’m sure they’re also paying attention to the question s proposed and will have answers for them at the ASM. They’re not stupid.
That’s on the regulators, not the company.
I agree diver. I want to be holding my shares tight when topline comes in. Lots of competing technology and drugs generating a lot of revenue to attack this little engine that could. It’s best we silently chug along until we reach the top.
I think DC Direct may the answer for hyperprogression. Injecting the vaccine directly into the tumor should allow it to attack from the inside out. Vascularization of the malignancy could be connected to treatment modality. More research will need to go into this.
Well written Ikeesq. Thank you for the time devoted to this project.
Would you both agree that while, very promising, Direct trials impose a financial liability to the company that they may not be able to afford currently? I can imagine that this is the reason Direct trials haven’t started. Until they have revenue or a partner for this pathway, it will be difficult for them to move forward with Direct.
I look forward to getting some answers from this years ASM. Our small consortium of shareholders is anxious for data, but also tired of promises not kept. We’re in this for potential of the product. Many of us have experience in cancer care and the biology of cancer. We see potential here and have put our money behind that potential. Personally, my biggest fear is corruption in government regulation and the potential for the FDA and others to overlook positive data. There is BIG money in treatment status quo and those profits will be protected vehemently. Paying regulators to create approval obstacles could be the means of maintaining status quo. Right to try was supposed to offer relief to that, but hasn’t gotten off the ground yet.
Trials are risky not just for failure, but for exposure to regulators. Data acceptance isn’t always guaranteed. Poor drugs are frequently approved probably due to the businesses that support them, while better therapies are overlooked.
The end of this story is coming and it feels like a suspense novel.
I can confirm the alpha’s claims on company ownership. Our group has about 1% of all outstanding shares, for better or worse.
Let’s get some answers and some topline data.
I vote for 1,7,16,24,31. Lots of great questions here. A good answer to any of them would be appreciated
But Marz...topline probably isn’t going to happen by the end of January. I’m going to lose the timeline pool. I was so looking forward to that cruise :)
With our new Huawei funding, I’d imagine data is coming in time for ASCO.
The regulatory situation continues to be quite interesting to me. I’ve thought about this quite a bit. If I were in charge of health and human services for a small tourist nation close to the US and Europe, I would reach out to company leadership here and offer up approval of DCVAX - L on the basis of the published interim blended data and excellent safety profile. It has to be obvious that a small portion of GBM patients would have their tumor removed and frozen, have the vaccine manufactured, and could travel to have the vaccine injected overseas. Think of how offshore gambling websites and apps are set up now to overcome regulatory issues. There may be opportunity to generate medical tourism travel for up and coming therapies to overcome the regulatory burden of the FDA.
It’s just another form of right to try, correct? I continue to wonder why patients are being prohibited from using DCVax with our new right to try laws.
If I were an educated patient with GBM, I’d explore this option...
Wasn’t Cognate paid for their manufacturing services with shares? Perhaps they needed the cash and liquidated their shares to pay for expenses?
What I don’t understand is how any former partner organization could come back to the table for more shares after being separated. Is this what is being proposed?
Does this have anything to do with Cognate being purchased by Blackrock?? After the split...Didn’t Cognate get purchased by Seqouia Capital in CA? Sequoia was then bought out by Blackrock? I always wondered if Blackrock was purchasing Sequoia to get its hands on the NWBO shares that came from Cognate.
I’m pretty sure she can’t get DCVAX. They need a tumor sample to make the vaccine. She can’t even get a needle biopsy due to the location of the tumor. Hopefully someday that will change.
This is great information. I knew that PET was involved, but I also know it is hard to differentiate between uptake values in the brain due to the hypermetabolic activity inherent to brain tissue.
I agree diver. The science here is solid, the detractors are merciless, and the silence has been deafening. What will be really interesting is the aftermath of unblinded trial data and how many doctors could downplay substantially positive data. What this trial could really tell us is how many physicians care about patients and how many of them care about their jobs and money.
I’ve heard that is the most effective way to differentiate.
You really want information about the long and broad survivorship tail in this trial. I can understand your wishes, but I also agree with company leadership and believe it’s prudent to unblind now.
Next press release will most likely be topline data. I expect it by end of February.
Should we be nervous? Because with their science and with 45 million in the bank, I’m just not there.
Should we be nervous? Because with their science and with 45 million in the bank, I’m just not there.
And maybe that’s what needs to happen.
I believe this whole article is the reason right to try was conceived and passed.
There’s no good guy or bad guy. But it is an underdog against a heavy favorite here with NWBO against the FDA. The burden of proof is on the underdog.
In some ways, the US is no different than any other empire. We just happen to be an empire controlled by big dollar capitalists. They own the media and, in many ways, the votes of the people. The votes help pay for the influence that is bought in Washington. Change in the US is slowed by money, which powers the business models that are favored by status quo.
But revolutions happen every day in every industry. The beauty of the US is that it is a melting pot of worldwide influence. NWBO can thrive on an idea that benefits humanity. They just have to prove it. And even if the US government doesn’t believe the evidence presented, other countries will have the opportunity to look beyond potential corruption and assess the science on their own.
I don’t know who is selling, but I’m buying!!!
It all comes down to DCVAX approval. What’s a successful 10 year trial against an orphan disease worth?
Sweet. I’ll buy some more there...