Stock of Interest (NWBO): Potentially Lose $0.5 or Gain $30 or More in Near Future[Finally Phase 3 Data Locked as of 5 Otc 2020, Results Soon!!!]

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Below is a month chat of nwbo stock trading as of 15:05 today:

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GBM ( Glioblastoma) is one type of brain cancers, the most deadly cancer of all cancers. If DCVax-L is approved efficacious and safe (safety has been already approved), it can also apply to other solid cancers. Besides DCVax-L which is designed for all operable solid cancers, the company has also own DCVax-D which is designed for all inoperable solid cancers. For GMB alone, the share price can reach as higher as $30 if the trial is very successful.
 

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Six month chart as of 15:13pm today which may reflect how the share price has been coming all along in recent months
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Bought some at 0.66 and 0.71. Enjoy the ride today!
 

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Bought more shares today. Have been averaging up for a while.
 

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For those of you who want to start a position or add to the existing ones, now is the good opportunity due to rumored possible delay of topline data, resulting in a big drop in share price. I bought three batches of more shares today (average up a bit more)
 

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Back up in anticipation of update by some and topline by other. All are good!
 
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Northwest Biotherapeutics Announces Data Lock of Phase III Trial



News provided by
Northwest Biotherapeutics
Oct 05, 2020, 09:34 ET


BETHESDA, Md., Oct. 5, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked.


With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.


The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.


"We are excited to be so close to the finish line now, after such a long road" commented Linda Powers, the Company's CEO. "We are hopeful that DCVax®-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer."


"We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges," Ms. Powers continued. "We are also very grateful to our shareholders for their patience and support, which has made all this possible."


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." The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and 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.



CONTACTS
Dave Innes Les Goldman
804-513-4758 dinnes@nwbio.com 240-234-0059 lgoldman@nwbio.com

SOURCE Northwest Biotherapeutics

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People are talking about this huge positive news:



The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses
E.2.2Secondary objectives of the trial
The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence and control patients from
comparable, contemporaneous clinical trials, in patients with recurrent GBM.
 

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Slightly outdated but still a good read:



Northwest Bio, Wow!
Oct. 9, 2020 4:12 PM ET
|
22 comments

|
About: Northwest Biotherapeutics, Inc. (NWBO)
Bohsie Research
Bohsie Research


Long Only, Deep Value, Special Situations, Biotech


(176 followers)
Summary
With Data Lock just announced, Top Line Date is imminent.
Numerous statistical and mathematical markers from available data shine a positive light on potential trial results.
The company may have a lucrative option even if median Overall Survival does not meet the secondary endpoints.
I have written about DCVax-L and Northwest Biotherapeutics in the past, crunching numbers, and statistically analyzing blinded data, and more so now I believe that even with the jump in share price, this undervalued stock has huge upside potential even in the worst scenario. With the blinded data we already have, and the last patient enrollment in November 2015, there is enough information already to show DCVax-L is a good investment. Here are my reasons:

1) We know that over 25% of the patients treated are showing a PFS greater than 15 months (and more likely 17 months +) (see my article) with the last enrollment occurring in November 2015, and the 248th PFS event occurring sometime between end of December 2016 and February 2017 (Article). With pseudo progressions being removed, even more so 15 months is unheard of, and no other trial has shown median PFS results over than 10 months. The Achilles heel of this trial is by no means the PFS Endpoint (mPFS), but rather the original secondary OS outcome (mOS) due mainly to the crossover.

2) This takes us to Overall Survivability. With the crossover, and with an effective vaccine, DCVax-L could actually ultimately hurt the trial itself by not meeting the 2 month increase in median Overall Survival. However, we know that the blinded mOS results are nearly two months greater than the blinded median OS results from the Optune trial, and over seven months greater than the SOC. And that is the blinded results. For the secondary outcomes to fail, the entire intent to treat population would need to show similar results to the treated Optune population. Additionally, there are shorts that try to add skepticism to these blinded results stating that all the intent to treat population used Optune treatments, resulting in the increased overall survival, however, as a statistician, this is statistically improbable, and secondly, the DCVax-L trial has been operating well before the Optune trial, years in fact. However, as I mentioned, if the vaccine is truly effective, then there is a chance that the two month increase will not be met, however, if that is the case, NWBO management will have a very strong case to compare these results to SOC populations, as recently approved by the FDA. I also wouldn't be surprised that NWBO rolled this comparison into their trial design when they recently received approval for their SAP (Statistical Analysis Plan). One area we do know that they are analyzing is with Methylated MGMY patients.


3) And that comes to my third point, Methylated and unMethylated MGMT patient data from blinded results show drastic increases in overall survival with increases of seven and nearly 10 months from blinded Optune results (see Statistically Significant article). If even one of these sub-population show drastic increases, these in itself will provide ample justification for approval of a vaccine that shows little if any side effects.

4) During the writing of this article, it was determined that not only was the SAP redefined in the EU, the primary endpoints of the study are now OS compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed gliobastoma. We already know that the blinded data shows much better results than control patients in every trial done to date, so this in itself is a huge positive assertion that there is a very good chance that the results will be positive. Additionally, a secondary endpoint is overall survival compared to contemporaneous clinical trials, in patients with recurrent GBM. I would even bet that this is similar to the SAP here in the U.S.

So after all this data and blinded information readily available, a redefined SAP that allows for comparison to contemporaneous trials, and even if the worse case scenario of the overall survival not meeting the two month increase, there is still enough positive outcomes from this trial that this would readily provide Linda Powers and her board ample bargaining power to sell NWBO's proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range, providing a share price of between $14 and $28 per share. Even if Big Pharma kept their wallets tight, a buyout of $5 billion would readily attract one company that feels like they are trailing the immunotherapy curve.

Of course, as is the issue with all stocks, risk plays a significant role, and this should always be taken into account when investing. However, as I have said many times, this stock has significant upside potential, even after the stock recent surge near the $1 range, it has the potential to skyrocket ten to twenty fold or more with positive results. I liken this stock to buying a lottery ticket with much better odds then one would ever get. However, one does not buy a lottery ticket without the understanding that it is not a given, and money may be lost, but the upside may be huge. At a share price hovering under $1, and the top line data expected any week, or even day now, this is readily an investment worth the risk, as the payoff may have you saying, Northwest Bio, WOW!


Disclosure: I am/we are long NWBO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: As with all stocks, there are risks associated with this recommendation, so understanding these risks and doing your own due diligence is necessary prior to investing.
 

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Mini-gap up today. Many good exciting things to come in the near future!
 

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New 52-week high today, but it's just beginning from grand scheme of things:

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Finally drawn Wall Street attention, Wow Prime Time!!!


DEDUCED RECKONING: Northwest Biotherapeutics is finally ready for prime time

By Joan Lappin, published 14 October 2020



Any cancer diagnosis is scary but nothing is more frightening than being told you have brain cancer. Glioblastoma (GBM) took U.S. Sens. John McCain and Ted Kennedy in very short order. The current standard of care was approved by the FDA in 2005 because it extended life by just two months.

It consists of resection (removal) of the tumor, radiation and chemotherapy, Merck’s Temodar (temozolomide, designed to shrink tumors). The Merck site for this drug warns you to ”wear rubber gloves, never touch it and never ever flush it down the toilet.” Possible side effects: nausea, vomiting … loss of balance, fainting, dizziness, hair loss … and seizures. Median survival is 15 months. Five-year survival is less than 6%.

Since 2005, more than 400 GBM trials have failed, some after promising Phase 2 studies. Northwest Bio undertook a completely different approach to this dread disease. Dr. Alton Boynton set out to harness the body’s own immune system to fight cancer. NWBO combines material from your own resected tumor with dendritic cells (withdrawn from your blood), which are then trained in the lab to recognize your tumor. Because the DCVAX-L that is ultimately returned to your body is your body’s own enhanced material it is not rejected as foreign. Therefore, there is no toxicity to this treatment. You might have redness at the site of the injection or a temporary headache, both addressed with acetaminophen. Either the drug works or it doesn’t.

In January 2019, the Sarasota Herald-Tribune got me a press pass to attend the Phacylitate Leaders World Conference in Miami. I believe I was the only analyst there when NWBO CEO Linda Powers gave a most astounding presentation. Read a summary on the company’s press page about all that has been learned about GBM over the 14 years under their lead scientist from UCLA, Dr. Linda Liau. Most stunning was the news that a single tumor could display more than 20,000 mutations of the original cancerous cells. Most of the chemo trials and other newer techniques have been aimed at designing a “silver bullet” that would kill the original cancer. That might gain you temporary remission but that drug becomes ineffective against the mutations. That would explain so many failed Phase 3 trials.

NWBO’s DC VAX-L is designed for the dendritic cells returned to your body to recognize both the tumor and its mutants. Because they are living cells, they can morph to combat the mutations as they come along and keep fighting your disease. While this trial was designed to investigate glioblastoma, the company believes it will work against all solid tumor cancers which are more than 80% of all cancers. Think of a body part that gets cancer and the drug can be made to fight it.

It is almost two years since I attended the Miami conference. I was not prepared to recommend it to you until now. I own it; Gramercy Capital and all of our clients own it. In recent weeks, NWBO has finally completed its Phase 3 trial. The data has been locked and sent off to the statisticians for evaluation.

Knowing that a lot of people who should be dead are not just alive but thriving, the trial was allowed to run for five years after the last patient was enrolled to gather complete data. Once the statisticians have analyzed the data, the study will be unblinded to the company and in turn to us.

Then a cascade of events will ensue: 1. The company will make a presentation at the Society of NeuroOncology on Nov. 20, at a main plenary session. 2. I anticipate that likely simultaneously an article will appear in a major medical journal of the importance of Cancer, Lancet, New England Journal or JAMA. 3. This stock will be relisted on a major stock exchange, perhaps even the NYSE making it easier for institutional investors to buy the stock. 4. This drug was “fast-tracked” in the UK in 2014 and I expect that a new drug application will be filed there very shortly after the results are known. 5. Applications will also be made in Germany, USA, and Canada. 6. UK approval could come in as few as three to five months after the filing pointing to approval as a 1H 2021 event.

Right now, NWBO is valued at less than $1 billion. If the trial is successful, and we will know quickly, this undervaluation will correct rapidly. Immunomedics was recently acquired for $21 billion by Gilead with a less promising drug. Like all biotech trials, this one can still fail. Do not spend more money than you can afford to lose but understand that this drug has the potential to alter all solid tumor cancer treatment for years to come.

Note to readers: Joan Lappin CFA will be speaking at the Money Show on Oct. 27 at 10:40 a.m. Free registration to the two-day event: Lappin.MoneyShow.com.

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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