Has anybody pointed a gun at your head forcing you to do anything? If you think you are really confident in your DD, you may know that you can put your money into where your mouth is: go short the stock or leave it. There are always greener pastures somewhere else.
BTW 1, I think you must have read my disclaimer in the first post, and I guess you are over 18 years old now so that you can make your independent decisions?
BTW 2, just a friendly reminder, 不要学得一副痞子习气, 动不动就代表别人说话.
To conclude, you have once again shown you have had absolutely no grasps on any small biotech companies!
Not to wast any more time to reply to your future post(s). Bye bye kid.
DCVax-L phase 3 trial has been updated recently, showing the Estimated Primary Completion Date is now November 2016 (Final data collection date for primary outcome measure) as compared to September 2016 which was updated in October 2015:
1) The trial is not dead which contradicts with the market (reflected with the extremely low share price of around $0.5);
2) The target trial completion day which is moved forward for only about two months suggests the targeted 248 PFS events could be reached in November; and
3) Now it has practically become a counting game between shorts and longs. If shorts are right, i.e., the trail fails, then the price could drop further but would recover within a short period of time after several promised combinational P2 trials for several different types of cancers start; and if the trial is a success, the share price would at least increase to about $15 ~ $20 range within a short period of time, i.e., days to reflect a market cap of around $3 billion which is only the market cap for many other promising biotech companies which have not had even a single drug/cancer vaccine/product approved.
At such a time and a low price, it seems to be no brainer the risk/reward ratio is strongly in favor of longs.
As of 13 June 2016, Linda Liau, the principal investigator of Northwest Biotherapeutics' DCVax-L Phase 3 trial for brain cancer, and one of the highest paid surgeons in the world is still proud of her achievement, developing the first cellular vaccine (DCVax) for brain cancer.
I will be also proud of her in achieving that wholeheartedly if DCVax is approved by FDA without any hesitation!
Again it is worthy of note that investing in small biotech companies is not only very hard, but damned hard.
"What achievement are you most proud of in your professional career? Developing the first cellular vaccine (DCVax) for brain cancer."
Film executive Ted Gagliano (Beverly Hills, Calif.) has committed $1 million to support the UCLA Department of Neurosurgery’s brain cancer research. As president of post-production at 20th Century Fox Studios, he has helped guide more than 500 films to the big screen during his 30-year career, including box-office blockbusters like “Avatar” and “Titanic.”
“We are deeply grateful to Mr. Gagliano for his compassion and farsighted vision,” said Dr. Neil Martin, chairman of neurosurgery at the David Geffen School of Medicine at UCLA. “His generous gift will enable the UCLA Department of Neurosurgery to pioneer new approaches to fighting aggressive brain cancer and enable more patients to lead longer lives.”
In an unexpected twist of fate, Gagliano was invited by a colleague to attend UCLA Neurosurgery’s 2011 Visionary Ball the same night that one of his closest friends was undergoing surgery to remove a glioblastoma, a fast-growing, lethal brain tumor. During the dinner gala, a patient at each table stood up and shared how a UCLA neurosurgeon had saved his or her life.
“The survivors’ personal stories of hope and courage really inspired me,” Gagliano recalled. “I was moved by the unfairness of brain disease, and it hit me how lucky I am to be healthy. I learned about the great work that UCLA does and wanted to do more to help.”
A tour of researcher Dr. Linda Liau’s laboratory helped seal Gagliano’s commitment. Her team has developed a novel vaccine that trains a patient’s immune system to recognize and destroy brain cancer cells, adding years to the patient’s life.
“Seeing my name on a building isn’t my thing,” Gagliano said. “What excites me is the chance to offer cancer patients a promising treatment that gives them hope and makes their lives better. That’s why I was fascinated by Dr. Liau’s vaccine work. She isn’t just surgically removing brain tumors; she’s looking for new ways to stop them in their tracks for good. I wanted to support research that she wouldn’t be able to do otherwise.”
The funds from Gagliano’s pledge will allow Liau to test a new approach that boosts the vaccine’s impact by strengthening the immune system.
“Mr. Gagliano’s generous support will enable my team to take a significant step forward in improving personalized therapies to fight glioblastoma,” said Liau, vice chair of neurosurgery and director of the UCLA Brain Tumor Program. “We are exploring new research advances and launching clinical trials that we hope will work better in keeping patients cancer-free longer.”
Pledging $1 million to support research was just Gagliano’s first step toward making a difference in brain cancer patients’ lives. Earlier this year, he joined the UCLA Department of Neurosurgery’s board of advisers and hosted the first annual Golden Portal Awards. Benefiting UCLA’s Brain Tumor Program, the event pays tribute to excellence in film and science.
The UCLA Department of Neurosurgery is committed to providing the most comprehensive patient care through innovative clinical programs in minimally invasive brain and spinal surgery; neuroendoscopy; neuro-oncology for adult and pediatric brain tumors; cerebrovascular surgery; stereotactic radiosurgery for brain and spinal disorders; surgery for movement disorders such as Parkinson’s disease; and epilepsy surgery. For 21 consecutive years, the department has been ranked among the top neurosurgery programs in the nation by U.S. News & World Report, including No. 1 in Los Angeles and No. 2 on the West Coast."
Since Donald Trump has won US presidential election, biotech stocks in general will enjoy a great year ahead beginning from today! Will nwbo be a Donald Trump kind of stock defying anything having said and done, I hope so.
Finally some encouraging news though not the registration P3-L trial, which may come sooner than most would think. Hopefully and I strongly believe this is just harbinger. meaning more to come.
Press Release NW Bio Announces Phase II Clinical Trial Program Combining DCVax®-L and Pembrolizumab (Keytruda®) for Colorectal Cancer
The beauty of this cooperation is the prestigious German university will rake the bill.
BETHESDA, Md., Nov. 17, 2016 /PRNewswire/ -- Northwest Biotherapeutics NWBO, +22.30% ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today joined the University Medical Center (UMC) of the Johannes Gutenberg University Mainz in Germany in announcing a Phase II clinical trial program combining DCVax®-L and Pembrolizumab (Keytruda®) for colorectal cancer with liver metastases.
The trial will be conducted as an investigator-initiated trial led by the University of Mainz, thereby substantially reducing the costs involved. NW Bio will provide the DCVax-L products and MSD Sharp & Dohme GmbH will provide the Pembrolizumab. (MSD Sharp & Dohme is the operating name used by U.S.-based Merck & Co., Inc. outside the U.S. and Canada.) All of the parties contributed to and approved the novel trial design.
This trial will combine a broad spectrum personalized vaccine (DCVax®-L) with a highly targeted checkpoint inhibitor drug (Pembrolizumab). In contrast, most combination trials to date have combined two specifically targeted agents, with no broad spectrum agent included.
Colorectal cancer represents a major unmet medical need. The number of new cases per year is second only to lung cancer, and colorectal cancer results in approximately 700,000 deaths per year in the Western world. Colorectal cancer is very heterogeneous and various therapies to date, including various immune therapies when used as a single agent, have been disappointing.
The UMC of Johannes Gutenberg University Mainz is a leading Center of Excellence for colorectal cancer, and especially liver metastases of colorectal cancer. The 1 [st] Department of Medicine provides a wide range of treatments and conducts a variety of clinical trials, especially in gastrointestinal oncology.
After the parties complete certain preparatory activities, including obtaining regulatory approvals, the Phase II trial will treat patients for up to 6 months with DCVax [®] -L and Pembrolizumab, followed by long-term follow-up regarding patient survival.
Linda Powers, CEO of NW Bio, noted that, "More than 2 years of planning and work have gone into developing this Phase II trial program. We are excited to work with a leading team to test the potential synergies of combining broad spectrum DCVax-L and targeted Pembrolizumab to treat a heterogeneous and challenging disease such as metastatic colorectal cancer."
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 the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients. GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a Phase I/II trial with DCVax-Direct for inoperable solid tumor cancers. It has completed the 40-patient Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company has received approval of a 5-year Hospital Exemption for the treatment of all gliomas (primary brain cancers) outside the clinical trial.
About MSD Sharp and Dohme GmbH
MSD Sharp and Dohme GmbH is the German subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, a leading healthcare company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health and animal health. It focuses on several key therapeutic areas, including Cardiovascular, Diabetes, Immunology, Infectious Disease, Oncology and Women's Health. It also has a strong pipeline in oncology with pembrolizumab (Keytruda [®] ) being the most advanced pharmaceutical product.
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. 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 and uncertainties related to the actions and decisions of Nasdaq, the Company's ongoing ability to raise additional capital, 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 including the actions and decisions of the FDA and other regulators, 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 and Cognate's abilities to carry out the intended manufacturing and expansions contemplated in the Cognate Agreements, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("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. You should not place undue reliance on any forward-looking statements. 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.
A letter from VP on today's news. Notice the statement "today the first of our Phase 2 trial programs was announced by the Center of Excellence at the University of Mainz, Germany"
"November 17, 2016
It is an exciting day for NW Bio. Building on more than 2 years of work and planning, today the first of our Phase 2 trial programs was announced by the Center of Excellence at the University of Mainz, Germany, who will lead this trial, as well as by us. This particular program involves a clinical trial of NW Bio’s DCVax®-L and Merck’s checkpoint inhibitor drug Pembrolizumab (Keytruda®) for metastatic colon cancer.
After regulatory approvals are obtained, the trial will be conducted as an investigator-initiated trial by leading experts at the University of Mainz. This approach also substantially reduces the cost of the trial.
As indicated in the release from the University of Mainz, it is anticipated that combining a broad spectrum therapeutic vaccine (DCVax-L), which is designed to mobilize an overall immune system response, with a very targeted checkpoint inhibitor (Pembrolizumab), which is designed to prevent the tumor from suppressing or repelling the immune attack, could prove to be quite synergisticWe are excited to be explore this potential synergy in colon cancer, which today results in over 700,000 deaths per year and for which there is an urgent need for new and better treatment options.
It is indeed an exciting day for NW Bio as we take an important step into the world of combo trials.
Thanks for all your help, support and patience…
Leslie J. Goldman
Senior Vice President for Business Development"
Donald Trump Going to reform FDA for Need of Patients for New & Innovative Medical Products
Donald is going to "Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products"
It is clear to any objective observer that the Affordable Care Act (ACA), which has resulted in rapidly rising premiums and deductibles, narrow networks, and health insurance, has not been a success. A Trump Administration will work with Congress to repeal the ACA and replace it with a solution that includes Health Savings Accounts (HSAs), and returns the historic role in regulating health insurance to the States. The Administration’s goal will be to create a patient-centered healthcare system that promotes choice, quality and affordability with health insurance and healthcare, and take any needed action to alleviate the burdens imposed on American families and businesses by the law.
To maximize choice and create a dynamic market for health insurance, the Administration will work with Congress to enable people to purchase insurance across state lines. The Administration also will work with both Congress and the States to re-establish high-risk pools – a proven approach to ensuring access to health insurance coverage for individuals who have significant medical expenses and who have not maintained continuous coverage.
The Administration recognizes that the problems with the U.S. health care system did not begin with – and will not end with the repeal of – the ACA. With the assistance of Congress and working with the States, as appropriate, the Administration will act to:
Protect individual conscience in healthcare
Protect innocent human life from conception to natural death, including the most defenseless and those Americans with disabilities
Advance research and development in healthcare
Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products
Modernize Medicare, so that it will be ready for the challenges with the coming retirement of the Baby Boom generation – and beyond
Maximize flexibility for States in administering Medicaid, to enable States to experiment with innovative methods to deliver healthcare to our low-income citizens."
"“This is a reminder of what we can do when we look out for one another,” the president said. “Like Joe Biden and so many other Americans, I’ve lost people I love deeply to cancer. I’ve heard often from those whose loved ones are suffering from Alzheimer’s, addiction and other debilitating diseases. Their heartbreak is real, and so we have a responsibility to respond with real solutions. This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”"
[That is the initial plea for raising funds for her treatment with DCVax.]
Kat is doing really well on her current chemo, feeling good but a little tired (probably from having a crazy 3 year old) the chemo is hitting harder each month though which is tough. We are still waiting for the FDA to sign off their mid trial review of DCVAX, the wait is getting a bit agonising and we are looking at what we can do. One option is to start the Check point inhibitor treatment which is expensive, potentially, we would need over £100,000 for this. (on top of saving money for DCVAX and Avastin).
While we wait on news from America and on our options, we thank you for you continued support and donations
Kat's Cure April 28 ·
we have some wonderful news. Kat recently had an MRI to make a comparable to the Post surgery MRI scan from October.
THERE HAS BEEN “A HUGE REDUCTION” in the tumour.
This was, if honest a huge surprise for many reasons, but obviously we are all over the moon!
Current chemotherapy was only expected to slow progression or hold things at bay, the news of such a important reduction is very significant.
We can’t wait to see DCVAX, Kat’s very own bespoke vaccine, take the final blow to destroy the remaining tumour cells once and for all.
Not only destroying them, but upgrading her immune system to attack them at every stage.
Kat's Cure July 24 ·
We got away for our first holiday this year at Wells Next to sea. Was a nice little break. Kat is going really well, So much so they are looking to reduce some of the other medications!
Kat's Cure September 10 · Milton Keynes, United Kingdom ·
After the craziness of how this year started it's been amazing to have a summer of music and relaxing. Kats last scan showed a huge reduction and a second scan is booked in for next month. I'm sure you will join us in crossing everything possible!!!
Our Christmas Miracle! [post today]
We have been quiet over the last few months going through our journey with some highs and some lows.
Earlier this year we flew to Memphis in America for Kat to have Stem Cells removed for DCVAX. (Also managed to Pop to Sun Records!)
The parts of Kat's tumour which had been surgically removed in November 2015 had already been flown over and the team there managed to create all 11 treatments (3 years’ worth) of DCVAX.
For the last two months there has been a small flare in Kat's scans, however they suspect this could actually be a reaction to the immunotherapy (DCVAX) which is apparently common.
This “Mystery” flare is the only visible enhancement, meaning that there is no visible remains of kat’s tumour! All the old tumour is gone. Which is an amazing Christmas gift!
The DCVAX journey has been a crazy one, from your fund raising efforts and support, the team at DCVAX and here in the UK including the Brains Trust.
Now, one year in to the this chapter we can finally announce its all been worth it!
There is always hope, faith and there is always opportunity for miracles.