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Just a couple of comments on your post, DCVax has been priced at $37k a year and vaccine supply is 3 years for $110K for a 3 year supply. If results show statistical significance for this trial and we have 154M shares outstanding, the PPS will go much higher than $1.50 IMO.
GLTA longs!
Doc, it could very well be a collaboration with UCLA on biomarker project for this Phase III trial but no way of telling. I would expect this project at UCLA and Fraunhofer will provide additional key information to support the trial data with regulators, at least I hope so!
Interesting below is link with a photo (Feb 2014)from Mike Brown from Reuters and he notes "biotechnology company will soon wrap up a late stage trial of the brain cancer drug called DCVax-L that began in 2008".
Now trial is approaching 3 years from this photo and trial endpoints still have not been met!
Robert Morris (L-R), Laura Turner and Derek Grice joke as they get out of their sterilized suits after demonstrating how DCVax-L is manufactured in a Northwest Biotherapeutics laboratory in Memphis, Tennessee, February 21, 2014. The biotechnology company will soon wrap up a late-stage trial of the brain-cancer drug called DCVax-L that began in 2008. Picture taken February 21, 2014. REUTERS/Mike Brown (UNITED STATES - Tags: BUSINESS HEALTH SCIENCE TECHNOLOGY)
http://www.alamy.com/stock-photo-robert-morris-l-r-laura-turner-and-derek-grice-joke-as-they-get-out-124141786.html
Yes those are my thoughts on this as well! Interesting as I had not come across this before when browsing the Fraunhofer site.
No but they update their web site often and I came across this as I check it fairly frequently and with all of their projects just to be listed there is a positive indication IMHO.
Scroll down the page under Therapy Vaildation you will see four tabs: Profile, Staff, Projects, Publications and click on Projects it is the 3rd one listed
Yes it should be as it opened when I clicked on it and then after page opens click on Programs and it is in there.
http://www.izi.fraunhofer.de/en/departments/leipzig-location/therapy-validation.html
No unfortunately I did not get a chance to call but I will try to speak with him today.
In my DD over many years, it was the DCVax science that attracted me to NWBO and I still believe this Phase III will garner approval with long tail survival. If crossover patients after progression are all "living longer" as stated by Dr. Liau then I cannot see regulators not approving this with an incredible safety profile where patients actually feel better on the vaccine with QOL being an important part of the approval. JMHO!
GLTA!
Hi beartrap, no it is one of just a few advanced programs at Fraunhofer to support clinical trail data for DCVax-L.This is a project at Fraunhofer which they have dedicated resources to.
Why is it so difficult for NWBO to provide an update on the following considering Fraunhofer still has DCVax-L prominently listed on their web site in their advanced therapy programs? It is been 26 months since this PR and Fraunhofer is obviously keeping this at the forefront of immunotherapy programs and patients applying for Hospital Exemption. Is it 1, 5,10 50 or 200 patients? Why can't they communicate this as it is obvious Fraunhofer is very supportive of this trial as you can see from their web site?
http://www.nwbio.com/dcvax-l-hospital-exemption-program-now-under-way-in-germany/
Fraunhofer Institute for Therapy Validation listing DCVax-L for Glioblastoma in a very small list of therapy validation projects and note very last sentence
My sentiments exactly!!
LOL, yes you do! Thanks for making me laugh...
I have tremendous respect for you as on oncology surgeon and cannot even fathom what you go through on a day to day basis with patients suffering from this dreadful disease called cancer. You have been so helpful to this board with your posts from a professional/expert in the field of oncology and many longs here appreciate reading your posts
I truly believe in the science of DCVax and I have been in sales, operations and senior management for 25+ years and I find myself starting to question their strategy here with their shareholders.
I need to call and have a discussion with Les and I am going to do that before the end of today.
The annual shareholders meeting should have provided that opportunity but without a webcast or conference line to present questions and answers they did not allow it for reasons known to NWBO. It was great we had representation at the meeting with few IHUB members, but I am a long term shareholder pre-nasdaq and starting to get a bit impatient with this lack of transparency especially now we are going on 4 weeks as of January 5th!
[/quote]"I can see a lot of angry people looking for some form of transparency from NWBO management"
Unfortunately this does not happen regardless, perhaps it should. The time to proper challenge management has only just recently gone by, the AGM. Management never had to provide any answers to the really 'difficult' issues most of which are still valid concerns. Until they are appropriately challenged nothing will happen. We are very much in their hands.[/quote]
She should never have put out a timeline like that if you can not meet it. She should have said "we requested an update on our Phase III trial and we will provide an update as soon as we have this information to review and present to shareholders.
We are now past 3 weeks with holidays and appraoching 4 weeks on Janaury 5th with no communication from management. If they do not update shareholders by end of the week, I can see a lot of angry people looking for some form of transparency from NWBO management
Yes he does and obviously does not care about shareholders or would would at least get some operational updates. Has anyone tried to contact him via email or phone?
Omair92 great post and appreciate you sharing this information. I did notice both large block BUYS were Form T transactions as well!
Over the last 30 minutes or so large blocks traded for about 1M shares and PPS does not even move. NITE sitting out there 50K on bid and 50K on ASK right now.
Where are all these shares coming from as Level II looks light for this volume
Over 1M shared traded in first 25 minutes today....lets see if this continues!
That would be welcomed by many here on this board, would you care to share your reasons?
Thanks Drilla! Happy and Prosperous New Year!
Drilla/Bob/Gus,
What is your recommendation on how we should proceed with this change on GDS conversion on 1/27? You planning on keeping invested in this company on Bovespa or selling out? TIA
Happy and Prosperous New Year!
What is your recommendation on how we should proceed wi
Email from Elizabeth Wilson, President and CEO of the American Brain Tumor Association
American Brain Tumor Association
Dear Friend,
Before the calendar turns to a new year, I’d like to share with you the progress we've made in 2016 and how it has paved the way for a promising year ahead:
•The American Brain Tumor Association (ABTA) continued its support of the research and scientists whose advances are fostering a greater understanding of brain tumors and the potential for better patient outcomes. In 2016, we piloted a new research grant funding mechanism – ABTA’s Collaborative Research Grants – to accelerate scientific progress by incentivizing team science and cross-institutional research projects.
•Our annual National Patient and Family Conference was the first gathering of patients, caregivers, researchers and clinicians following the World Health Organization's first global reclassification of brain tumors in 100 years. The announcement heralded the arrival of personalized medicine to the brain tumor community, and the ABTA conference brought greater understanding of these changes to patients and families who stand to benefit from them.
•We engaged in robust discussions with clinicians, researchers, industry and allied advocacy groups on the challenges of brain tumor symptom management and the research and awareness required to improve the quality of life for patients and families living with a high-grade, low-grade, meningioma, metastatic and pediatric brain tumor diagnosis.
•We funded the first in-depth statistical analysis of brain and central nervous system tumors in adolescent and young adults. The report, compiled by the Central Brain Tumor Registry of the United States and published in the journal Neuro-Oncology, found that malignant brain tumors to be the most common cause of cancer-related deaths in adolescents and young adults aged 15-39 and the most common cancer occurring among 15-19 year olds.
•And through targeted and collaborative advocacy efforts, we helped to secure bipartisan support of the 21st Century Cures Act, brain cancer research eligible for funding by the Department of Defense's Peer Reviewed Cancer Research Program, as well as funding for the Brain Initiative and the Cancer Moonshot. The ABTA’s advocacy efforts kick off the first week of 2017 at a White House meeting on the Cancer Moonshot.
Momentum is building in brain tumor research, treatment and care, and we are learning more every day. As we welcome the New Year, the ABTA remains resolute in our pursuit of the brain tumor breakthroughs we all seek.
If you haven’t done so already, it’s not too late to make a year-end gift to the American Brain Tumor Association. Your generosity will help us build on the progress of 2016 toward a brighter future full of potential in the year ahead.
Thank you in advance for your support.
Elizabeth M. Wilson
President and CEO
American Brain Tumor Association
lockout what is it? Finally seeing some small volume here for once and PPS moving upward!
Has Neil Woodford finally lost his touch after a woeful year?
By The Motley Fool Dec 29, 2016
Updated: Dec 29th 2016 09:15 AM
http://money.aol.co.uk/2016/12/29/has-neil-woodford-finally-lost-his-touch-after-a-woeful-year/
Very seldom does a company have a good PR go out on a holiday week like this one where large number of the investment community are on vacation and business has slowed to a crawl. If NWBO PR's anything, I exepect it in the next week when many return back to work and kids are back in school. JMO
Yes... Deals would keep this board active and provide updates. Maza needs to communicate an update on things, good , bad, indifferent, etc. and what he is trying to do to with the IP pipeline, etc.
I hold my shares as they are basically worth nothing, pretty pathetic investment!
Drilla, how does this affect us short term 30 days and next few months. I am not sure I understand this correctly. Any help is much appreciated!
MATERIAL FACT Petro Rio S.A.
DELISTING FROM TSX-v IN
CONNECTION WITH TERMINATION OF GDS PROGRAM
Rio de Janeiro, December 28, 2016 - Petro Rio S.A. ("PetroRio" or the "Company") (BM&FBOVESPA: PRIO3, TSX-V: PRJ) announces today that all of the issued and outstanding global depositary shares ("GDS") will be delisted from the TSX Venture Exchange ("TSXV") following the close of the trading session of January 27, 2017.
The delisting will occur in connection with the termination of the deposit agreement among the owners and holders of GDS ("GDS holders"), Deutsche Bank Trust Company Americas ("Deutsche Bank") and the Company (the "Deposit Agreement") which is anticipated to occur on January 27, 2017 (the "Termination Date"). Commencing on the Termination Date and ending on the date that is four months after the Termination Date, Deutsche Bank will, upon request from GDS holders, deliver the underlying Common Shares to such holders of GDS in accordance with the terms and conditions of the Deposit Agreement and such GDS holders' written instructions. In the absence of written instructions from the GDS holders or their agents by the end of such four month period as to how the underlying Common Shares are to be delivered to a valid brokerage account, such Common Shares to which the former GDS holder was entitled will be sold in the market by Deutsche Bank and the net proceeds remitted to the former GDS holder.
The Common Shares will continue to be traded on the facilities of the BM&FBovespa in Brazil and GDS holders, if they provide instructions to receive Common Shares, will be able to sell the Common Shares received upon termination of the GDS program on such exchange without restriction, save for the general application of Brazilian securities and tax laws.
For further information, please contact the Company´s Investor Relations Department.
Sedar Profile # 00031536
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FYI-Wall Street Journal as of 12/15/2016 shows 3M reduction in short interest under table Largest Negative Changes.
http://www.wsj.com/mdc/public/page/2_3062-nasdaqshort-highlites.html
Thanks Drilla it is much appreciated!
I was not referencing the Primary and Secondary endpoints but Other Outcome Measures from the clinical trial site. I do not remember them presenting the following below and was a posting on here about another Direct patient update in January.
As of the June 15, 2015 PR 4 patients were still in the process of completing their study visits
Other Outcome Measures: •Number of patients surviving [ Time Frame: 24 months ] [ Designated as safety issue: No ]
•Number of patients surviving without tumor progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Bethesda, MD, June 1, 2015– Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, over the weekend in Chicago released promising new data on their Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors.
The patients enrolled in the trial had late stage cancers, with an average of three inoperable tumors. The patients had failed multiple prior therapies and had a poor prognosis.
The trial enrolled 40 patients, and 39 were evaluable. A conservative treatment regimen was used. Although the patients had multiple inoperable tumors, only 1 tumor was injected with DCVax-Direct. The treatments included only 3 injections in the first 2 weeks (Day 0, 7 and 14), and up to 3 additional injections spaced months apart thereafter (Weeks 8, 16 and 32), over a total period of 8 months.
Patients typically received their first injection about 1-1/2 months after recruitment. Four patients are still in the process of completing the study visits, and data collection is ongoing on all of the patients.
The trial tested three different dose levels of DCVax-Direct, two different methods of activating the dendritic cells that comprise DCVax-Direct, and a dozen different cancers. Findings to date include encouraging survival data and substantial induction of immune checkpoint expression (PD-L1).
DCVax Direct reaching Final Data Collection and Other Outcome Measure (# of Patients Surviving and # of Patients Without Tumor Progression) is December 2016 as noted below. We should be getting an update on this soon!
Further study details as provided by Northwest Biotherapeutics:
Primary Outcome Measures: •Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures: •Number of patients with tumor response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Other Outcome Measures: •Number of patients surviving [ Time Frame: 24 months ] [ Designated as safety issue: No ]
•Number of patients surviving without tumor progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Happy, the SEC may be participating in discussions with NWBO in the Cofer Black stock manipulation investigation as well?
Makes a lot of sense and logical reason on the halt of screening new patients into the trial! I am sure we will find out if this is correct when the primary endpoint of this International Phase III trial for GBM has reached its Primary Endpoint and data is locked, analyzed and eventually presented to the market.
Drilla, is the current outstanding shares 1.5M correct below? When do you see some return on this investment for HRTPY ? TIA!
Release date- 02122016 - Rio de Janeiro - Petro Rio S.A. (BM&FBOVESPA: PRIO3, TSX-V: PRJ), announces that the records of the TSX Venture Exchange have been updated to reflect the number of PetroRio's Global Depositary Shares currently outstanding.
On December 1st, 2016, there were 1,497,588 GDS outstanding (each representing 1/2 of an interest in a common share of PetroRio). Further details regarding the GDS can be found in the Company's annual information form.
Very well said and I agree with you on communication to shareholders and updates when timeline is being pushed out even if it was just an email.
Expanded Access Trial at one of Boston's best hospitals and cancer centers is still recruiting with expected approximate enrollment of 99 patients.
They must have some pretty good data on this group since the study started in May 2014?
An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients with Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221 - Learn More.
http://www.bidmc.org/Centers-and-Departments/Departments/Cancer-Center/Bone-Marrow-Transplantation/Clinical-Trials.aspx
https://clinicaltrials.gov/ct2/show/NCT02146066
Elecsol28, this is great news if what you are stating is true. I have been told by my close friend, senior level government law enforcement, Cofer Black is a very skilled and would have connections to many government agencies and resources for his investigation. I would love to see this criminal activity prosecuted so NWBO can bring this great vaccine to the patients that benefit from it.