DEDUCED RECKONING: Northwest Biotherapeutics is finally ready for prime time [医药生物投资]

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DEDUCED RECKONING: Northwest Bio, the perfect stocking stuffer​


Joan Lappin, Sarasota Herald-Tribune 2 hours ago

When I first started writing here about Advanced Micro Devices at $11, the leading analysts on Wall Street were detractors, and one predicted the stock was going to $6. It never did and is now in the $90s. AMD had major risks then. Now, everyone loves it, so it is no longer a bargain.

In October, when I drew your attention to NWBO, like AMD years before, I wrote that it was not without many detractors or risks. Any biotech company, or any government regulated entity in any field, can always suffer at the hands of those regulators. For that reason, I wrote that this was a tiny company with limited staff and money and therefore a risky investment until we knew the trial had succeeded.

The most important fourth-quarter event for NWBio’s path to drug approval was the unblinding of its 15-year trial for DCVAX-L. On Oct. 5, the company issued a press release outlining the many steps that would ensue including the “unblinding” of the company’s management to the results of the statistical analysis of the data. The independent statisticians completed their analysis, and I am fairly certain based on public events that the company now has been unblinded to the data. HOWEVER, and this is a huge however, if the trial had failed, SEC rules require that they had to reveal that to investors within four days. Instead, weeks have passed without a word, so by inference we now know the trial was a success. This is the largest and longest such trial ever run and the only one of more than 400 to reach a happy result. The lead investigators and their collaborators are hard at work on a paper to be published in a major medical journal. Until then, the company is in a “quiet period.”

While COVID-19 slowed the company’s ability to get information from hospitals and doctors to complete the lockdown of its data, it also helped in a very major way. While many believe the Trump administration badly mishandled the pandemic in the United States, Trump did initiate Project Warp Speed to accelerate a vaccine and to speed drug approvals in the future. Trump recognized that the FDA, just like its UK counterparts MHRA and NICE, were slow, plodding mechanisms that caused drugs to take forever to be approved.

Long before COVID-19, the UK set up a mechanism to identify very promising drugs for unmet needs like that of patients who contract glioblastoma. NWBO was one of three such drugs given this fast-track treatment in 2014. Six years later it seems a joke, but once they submit their drug application, they are assured a very fast review. That review time has been accelerated even more this year as the UK deals with BREXIT and wants very much to remain at the forefront of drug approvals. That is why it beat the U.S. to approval of the Pfizer BioNTech vaccine now in distribution here and in the UK.

While this is still not without risk, NWBO is now selling for $1.40 a share. There are just under 1 billion shares outstanding. This drug is applicable to all 15 solid tumor cancers. Think of a body part that gets cancer, and animal trials have shown it will work in all of them. This is a vaccine manufactured from your own dendritic cells so there is no toxicity to it. Northwest manufactures your own product and then flash-freezes it. If you have enough dendritic cells, they can sometimes make enough for years. The UK evaluates drugs on the basis of how many months you live for the cost to keep you alive. DC VAX costs a fraction of a year of Keytruda, which costs more than $400,000 per dose. Because it is not toxic and is made from your own cells, unlike with chemotherapy, your body is not in a race for the drug to kill your cancer before it kills you.

This cheap relative price of DCVAX-L is one of the principal reasons that Big Pharma has been so anxious to kill off NWBO and other small drug companies like it. The little guys don’t have the clout at the FDA, they don’t have giant staffs of people to undertake and complete trials, and they don’t have the fat checkbooks. That is why Northwest was forced to keep selling shares at $0.15 and $0.20 last year just to keep going, and it is why there are so many shares outstanding. Through sheer wiliness and determination, they have slogged on. At its current price, it is a perfect stocking stuffer for a loved one. It is not a widow or orphan stock, but the odds have started to tilt much more in our favor. That’s why I own it, and so do the clients of Gramercy Capital who have each made their own decision to do so because most of us have known someone who has been taken out by glioblastoma.

Joan Lappin CFA has been called an “investment guru” by Business Week and a “top manager” by the Wall Street Journal. The Sarasota resident founded Gramercy Capital Management, a registered investment adviser, in 1986. Email her at JLappincfa@gmail.com. Follow her on twitter: @joanlappin. Her past columns appear at heraldtribune.com/business/columns.
 

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赞楼主!
对于菜鸟而言,从何做起?楼主有没有关于简易攻略的帖子推荐?
 

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谢谢你的好言。“度假”刚回,抱歉迟复。任何股市入门书籍皆可作为入门。可以用一部分多余的钱(即使全部输掉也不至于影响你的生活)先练练手,逐渐积累经验。先以不输钱为目的,一年下来如果保住本金你就赢了。多数新手多会有好运,然后胃口变大,然后交学费。。。总之祝好运!
 

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Nothing has changed. We are still waiting for unblinded data release, and yet a mini short attack.

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One month or six months after today, what will be the price? What landscape will have change in treating deadly cancers?

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The new $11 million financing deal is unsecured ( meaning there are no assets as its backing) so that it suggests the lender must have signed a NDA because nobody would risk that kind of money if the company would be in default in near future due to negative trial data.

 

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NWBO Rises this morning without news. Hope news is coming:

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Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK Facility

Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK Facility​

Application for MHRA Regulatory Certification of Facility In Preparation
Northwest Biotherapeutics Logo. (PRNewsFoto/Northwest Biotherapeutics, Inc.)




News provided by
Northwest Biotherapeutics
Mar 16, 2021, 09:30 ET

BETHESDA, Md., March 16, 2021 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that development of the initial production capacity of the Company's Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority ("MHRA").
To date, the Company's production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 - 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval.
An intensive recruitment program has been underway for well over a year, and has successfully hired and trained the necessary 30 senior technical managers, scientists and staff technicians and operators for manufacturing, quality control and other operations of the first two production suites. The recruitment process for experienced personnel with these types of expertise is highly competitive because the cell therapy and immunotherapy fields are growing rapidly and the pool of experienced specialists is very limited. With the initial team of 30 specialists on board and trained, the recruitment and training are now continuing to expand the team. When the Sawston facility is fully built out and in full operation, it is estimated that it will employ in excess of 300 highly skilled personnel, including many who may be trained through apprenticeships in the Sawston facility.
Since the initial dendritic cell vaccine production capacity will occupy only a small fraction of the total space in the Sawston facility, it is anticipated that additional capacity for third party production of other cell therapy products may be developed in some of the other space. GMP facilities are capital intensive both to develop and to operate. Third party production of other products will help support the Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility. The capacity for production of other products will also be an important resource for the region.
Development of the Sawston facility has been under way for more than two years, and has progressed on parallel tracks in multiple areas, including physical buildout of the first two production suites, equipment procurement and validation, specialized operating systems, drafting of regulatory documents, and recruitment and training of key scientific and technical personnel for the first two production suites.
All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.
The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages. Each of these stages has taken many months of work. In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.). Those data then form a major part of the application to MHRA for certification of the first phase of the facility. The Company currently anticipates that the PQ stage will be completed and the certification application will be submitted to MHRA within approximately the next six to eight weeks.
The physical buildout of Phase 1a of the facility was carried out last year, and was completed ahead of schedule at the beginning of October despite COVID operating restrictions, by having the contractors work double shifts and other special measures. Advent BioServices worked with R.G. Carter as the general contractor.
R.G. Carter and its team of sub-contractors did an exceptional job of overcoming the COVID related difficulties and achieving the early completion. For example, they enabled and managed double shifts throughout the project, worked out special operating arrangements to enable construction to proceed in a socially distanced manner, found alternate sources for specialized materials when the original suppliers were unable to deliver, and made special travel arrangements to bring European equipment vendors' installation engineers to Sawston. The Company is grateful to R.G. Carter and its sub-contractors for these special arrangements and solutions, and is looking forward to working with this team on subsequent phases of the Sawston facility.
Phase 1a cost approximately £3.5 million ($4.6 million), including the double shift costs, and covered the support facilities for the first two manufacturing suites, which had already been built. Approximately £1.35 million ($1.77 million) of the Phase 1a cost was funded through a competitive loan from the Cambridgeshire and Peterborough Development Authority. This funding was instrumental in enabling the Sawston facility to reach initial manufacturing readiness. The Company is very grateful to the Development Authority for this funding, and is looking forward to continuing to work with the Authority.
Following the physical buildout, the extensive and specialized equipment was sourced, installed, tested and validated. The COVID circumstances posed a number of difficulties. For example, there were supply chain and delivery difficulties to obtain the equipment. In addition, foreign vendors were unable to travel to the UK to conduct the installation, testing and validation as would usually occur. UK personnel had to go through training to conduct these activities instead of the vendor. The data from the testing and validation of each individual piece of equipment is required for the application package for certification of the facility. This work is now in the process of being completed.
Certain specialized operating systems (environmental management systems, quality management systems, lab information management systems and others) are required to measure, tightly control and collect data on air flow sterility and turnover, particle counts, and other conditions, as well as lab operations. The sourcing, installation, testing and validation of these specialized systems also encountered difficulties due to COVID, but are now nearing completion.
In parallel with the physical buildout, the equipment and the specialized operating systems, an intensive program has been under way to draft the necessary SOPs (standard operating procedures) and other regulatory documents. SOPs are tailored to a specific facility and cannot be procured ready-made. Detailed SOPs must cover every aspect of the facility's operations, from the time supplies arrive at the loading dock and are placed in quarantined storage all the way through to the release of finished doses of the dendritic cell vaccines to the physician and patient. Over 500 SOPs and other regulatory documents have been drafted and tested over the last year-plus period, involving many, many thousands of man hours. This set of regulatory documents is now essentially complete for the initial launch of product manufacturing in the Sawston facility.
As previously reported, the Company has also been moving forward on optimization of the Flaskworks system for manufacturing of dendritic cell vaccines. The buildout of the Sawston facility is purposefully being done in phases, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. It is anticipated that implementation of the Flaskworks system will enable the buildout of some or all of the rest of the 88,345 square foot facility, beyond the initial manufacturing suites, to be simplified and streamlined at reduced cost.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." This Phase III trial is now completed and locked down, with announcement of top line data expected in the coming months. The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTSDave Innes Les Goldman804-513-4758 dinnes@nwbio.com 240-234-0059 lgoldman@nwbio.com
SOURCE Northwest Biotherapeutics
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Definition of patience: it's a state years after one has invested in NWBO.

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Expert Financial Analysis and Reporting​


Could There Have Been Hundreds of Millions or Even More Than a Billion Counterfeit Shares of Northwest Biotherapeutics Created Through Illegal Naked Shorting?
Posted by Larry Smith on Mar 28, 2021 • (0)

I am often asked how I can hypothesize that there may be such an unbelievably large number of counterfeit shares of NWBO that have been created through illegal naked shorting? A look at the GameStop short squeeze gives a real world example suggesting that the hedge fund Melvin Capital could have been short the equivalent of a number of shares equal to or greater than the 63 million issued and outstanding shares of GameStop. If this was the case with GameStop, it might also be the case with Northwest Biotherapeutics.
We saw in the case of GameStop that Melvin Capital lost over $6 billion in a short period of time with much of this purportedly due to a short position in GameStop. We don’t know how much was lost on GameStop and how much on other positions. We can only guess at how many shares were shorted, at what price they were shorted and at what price they were covered. So we have three unconstrained variables making for an impossible to solve equation. Of course, one subpoena from the House Financial Services Committee could fill in the blanks quickly.
For the sake of argument, let's assume that Melvin was short 63 million shares which shockingly is equivalent to the number of legitimately issued shares. If the difference between the shorting price and the cover price was $10, Melvin would have lost $630 million. If the difference was $50, Melvin would have lost $3 billion on the position. Comments made by CEO Gabe Plotkin on CNBC suggest that the loss per share was less than $50, but he did not explicitly say so.
We know that in total Melvin lost over $6 billion with much due to the GameStop short so that both of these calculations out of an infinite number seem intuitively to be a reasonable possibility. Also, reasonably possible is that Melvin could have been short 126 million shares, twice the number of legally issued shares. If we assume the hedge fund covered with a loss of $30 per share. Melvin's loss would have been around $4 billion as compared to the overall $6 billion that was lost. Again intuitively, this seems possible. Hence, we can come up with some reasonable scenarios in which Melvin shorted the entire company once or even twice over. However, I want to emphasize that these are just a few of an infinite number of possibilities.
Obviously, Melvin could not have shorted this number of shares by borrowing them in a legal shorting maneuver. How could you borrow all or more of the outstanding shares and in any event the interest carrying expense would have been astronomical? However, if they sold counterfeit shares, there is no limitation to the number of shares that can be counterfeited and since they weren’t actually borrowed, there would be no interest expense.
This real world experience strongly supports but does not prove my hypothesis that illegal naked shorting has created an unimaginably huge number of counterfeit shares of NWBO. The market capitalizations of GameStop and NWBO are comparable so if Melvin was short the equivalent of one or two times the number of legitimate shares of GameStop, could it be the case that the wolfpack in the aggregate has done something similar to NWBO? If so, there could well be hundreds of millions or perhaps more than a billion counterfeit shares outstanding. The wolfpack appears to be at great risk if the phase 3 data leads investors to conclude that DCVax-L is approvable. This would be poetic justice.
Do you find it curious that hedge funds Point 72 and Citron rushed in to save Melvin? I thought they were ruthless competitors.

Tagged as illegal naked shorting, Northwest Biotherapeutics Inc. + Categorized as LinkedIn, Smith On Stocks Blog


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