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Great job on timeline of upcoming events and payments related around them! IMO Looks like some significant news coming!
Great post!! IMHO you nailed it!!
was tempted to buy more and withheld and great your average is $.8 and nice upside when this makes its move on Phase III news! GLTA longs as well!
It is trying to get above $.40 and NITE is playing dirty here!! They will get caught in this large scale manipulation scheme!!
Great point Chris! I remember that as well!
iwasdiver....so very well said and appreciate your posts so much as a physician in the real world and you provide some great thought provoking posts that I always enjoy reading.
highway....my sincere condolences on the loss of your father in law to cancer. He will be in my thoughts and prayers.
So much progress being made each day in this fight against cancer! Would love to see NWBO in the forefront for all operable and inoperable solid tumor cancers. This 8k today is a good sign IMO that we are getting close to big news.
Great point Flip for right to try state such as California could apply to Jessica Oldwyn who Dr. Liau operated on her brain tumor recurrence last Friday. God bless these patients and families as they have gone through so much!
Great post and agree with you 100% on UCLA are some of the best in the world in their field.
biosectinvestor....Bravo on this reply! So very well said!
You are very balanced and add so much value to this board!
Flip good point! I just left it like it was presented at Fraunhofer and should have noted its has been there for a while now. Just a reminder that validation and partner support on the GBM trial that if the trial was futile as the some on this board will say, Fraunhofer would have removed this from the site a long time ago.
And yes I saw those postings and realized what they were trying to do!Nothing surprises me the lengths they will go to spread FUD!
momentum....it has been there for a while (if not important Fraunhofer would have removed it)and remains a key project for Fraunhofer, I just wanted to post it again to remind everyone how these prestigious institutions partner with NWBO and DCVax.
I probably should have noted that in the post.
NWBO pricing model for DCVax was $37,000 US a year and (3) year supply for $111,000 US unless they have changed since it was presented a few years back. I cannot see how with the efficacy and statistical significance I expect to see in the Phase III GBM trial, regulators will approve quickly knowing manufacturing infrastructure for commercialization is ready and tested. Clock is ticking!!
Fraunhofer Projects: Therapy Validation: DCVax-L
Companion diagnostic for a clinical trial (Phase III) to evaluate the immunotherapeutic DCVax®-L for the treatment of Glioblastoma Multiforme
DCVax®-L (Northwest Biotherapeutics GmbH) is a therapeutic agent based on endogenous immune cells that will be used for treating Glioblastoma Multiforme after standard therapy. The treatment is based on immune cells of the peripheral blood which are differentiated in vitro to specific antigen-presenting cells, dendritic cells (DCs). The immature DCs are subsequently brought into contact with a tumor lysate, and thereby "trained" to recognize tumor cells. The maturated DCs are injected into the patient and can now trigger an immune response against remaining tumor cells. As part of a clinical trial (Phase III) to test the efficacy of DCVax®-L, cells from patients' peripheral blood (peripheral blood mononuclear cells; PBMCs) are isolated, quality controlled and cryopreserved for long-term storage. The aim of the project is to develop suitable diagnostic assays which can demonstrate a functional immune response in patients after treatment with DCVax®-L to support clinical data.
Project manager
Dr. Ulla Schwertassek
http://www.izi.fraunhofer.de/en/departments/leipzig-location/therapy-validation.html
Another great find! Interesting UCLA is now actively presenting immunotherapy in upcoming presentations 3/6 and now this on 3/16 at UCLA! DCvax is their long term study!
Love the caption "personalized immunotherapy approaches for glioblastoma"!
Thanks for sharing evaluate! The price sensitivity jumps out at you when reading this! This will not be an issue with NWBO as we already know their pricing model($111k, 3 yr supply) and my opinion this is the main reason why they with garner UK approval as well as FDA approval as this is lower cost than SOC today!
I am enthusiastic on the NICE appraisal (committee completed 2/23/2017) for NWBO because their pricing for a three year supply of the vaccine was $111,000 or $37,000 per year as per NWBO in the past. It is drastically lower than Keytruda/Optivo and standard of care.
NICE appraisal as Chris stated has been ongoing since last summer with them contacting NWBO. The NICE appraisal committee just finished their review on February 23rd and my belief is this will not wait until 2018 for publication as one poster claims. We will hear in 2017 and could be any day as GBM and brain cancers in general are unmet need and has urgency. This all coincides with the UK granting $2M£ for manufacturing facility for DCVax-L in UK which many of us have posted on numerous occasions over the past 18 months.
momentum....Yes to both
Knight Capital SEC Violations and they are just continuing their naked shorting over the years! Very blatant disregard for compliance and laugh at these minuscule fines.
Does the Cofer Black connections in high level government positions finally go after them?
Did you ever think the SEC visit to NWBO could be part of Cofer Black's investigation on stock manipulation and naked shorting because I do!
I would not be surprised a criminal case and law suit is brought against who ever was involved in this activity and announced in the future.
Chris, I agree with you and just a matter of time and probably before the trial even reaches OS endpoint as mentioned "several months"Feb 6th PR. NWBO in continuing discussions with regulators will want to get DCVax-L to brain cancer patients as soon as possible.
IMHO you are on the right path with your posts.
I guess we will find out who is right in near future! The NICE appraisal was finished on February 23rd and there is no way NICE will hold to 2018 publication date if DCVax-L is approved by regulators in 2017 as we all know NWBO has been in discussions with regulators (SEC filings) and trial is nearing completion. If data is statistically significant and approval granted, NWBO ready for commercialization ( (16) pieces of biologic automation production equipment shipped to Cognate over past 4 months, Fraunhofer buildout, UK $2M £ buildout for DCVax-L, over (80) clinics trained and ready, regulators will want to get this to patients as quickly as possible.
NICE Recommends Ocaliva® (obeticholic acid) for the Treatment of Patients with Primary Biliary Cholangitis in England, Wales and Northern Ireland
Is NWBO next???
HUGIN 4:31 AM ET 3/2/2017
ICPT 128.99 0 (0%)
QUOTES AS OF 04:00:00 PM ET 03/01/2017
First new medication for primary biliary cholangitis in nearly 20 years
Rapid NICE approval only two months after marketing authorization in the EU; one of the fastest approvals to date for an orphan medicine
NEW YORK, March 02, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc.(ICPT) today announced that the National Institute for Health and Care Excellence (NICE) has approved Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland. Ocaliva has been conditionally approved in the European Union for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. The NHS is expected to make Ocaliva available to patients with PBC within 90 days of NICE's final appraisal publication and Intercept will work with local reimbursement authorities to help ensure eligible patients obtain access. Although it is a rare disease, PBC is a leading cause of liver transplantation in adult women in the UK. Ocaliva is a new treatment option for patients with PBC who do not fully respond to, or are intolerant to, current treatment and remain at risk of their disease progressing toward cirrhosis, liver transplantation or death. "I am excited to see that the substantial group of PBC patients who are not achieving treatment goals with UDCA alone or who cannot tolerate UDCA will soon be able to access the first new therapeutic option in nearly 20 years. This truly is good news for our PBC patients," said David Jones, M.D., Ph.D., Professor of Liver Immunology at Newcastle University and Consultant Hepatologist at Newcastle upon Tyne Hospitals Trust, which hosts one of Europe's leading clinical services in the disease. "The development of new treatments for PBC is a powerful example of the medical innovation that can occur when government, industry, academia, community clinicians and, most importantly, patients come together to address an unmet need." Ocaliva is a potent and selective agonist of the farnesoid X receptor (FXR), which is expressed at high levels in the liver and intestine and thought to be a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. In December 2016, Ocaliva received conditional marketing authorization in Europe based on efficacy and safety data derived from three randomized double-blind, placebo-controlled clinical trials evaluating the effect of Ocaliva on alkaline phosphatase (ALP) and bilirubin in patients with PBC. The marketing authorization was also supported by two clinical databases that include more than 10,000 patients from the Global PBC Study Group and UK-PBC Group, both independently confirming that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival. The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%). Adverse reactions leading to discontinuation were 1% in the Ocaliva titration arm and 11% in the Ocaliva 10 mg arm. The most common adverse reaction leading to discontinuation was pruritus. The majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing. "This very rapid decision by NICE, one of the fastest approvals to date for an orphan medication, is an important affirmation of the scientific innovation, clinical value and cost-effectiveness of Ocaliva by one of the most respected health technology assessment bodies," said Lisa Bright, Intercept's President, International. "We welcome NICE's decision to provide broad access to Ocaliva and we owe a tremendous debt to people living with PBC and the clinical groups who helped us to achieve this milestone for the PBC community." "It is exciting news for PBC patients that this new treatment option will now be routinely available in England, Wales and Northern Ireland," said Collette Thain MBE, CEO of The PBC Foundation. "When I was diagnosed with PBC, UDCA was the only approved treatment option and PBC wasn't a major priority for many researchers. Thankfully, so much has changed for people living with PBC since then. After decades of advocacy from the PBC community, we have a new treatment option, a growing awareness of the disease among the general public, greater expertise amongst clinicians and an acceleration of PBC research in the UK and around the globe."
Innovative Drugs for Europe - Dr. Martina Schüssler-Lenz of the Paul-Ehrlich-Institut elected as chairman of the EU Committee for Advanced Therapies
In February of this year, Dr. Martina Schüssler-Lenz, a clinical assistant to the Department of Medical Biotechnology at the Paul-Ehrlich-Institut ( PEI ), became the Chair of the Committee for Advanced Therapies at the European Medicines Agency EMA Selected.
http://www.pei.de/DE/home/de-node.html
My comment: I am sure she is very aware of DCVaxl-L and GBM trial when NWBO went through PEI evaluation for the start of the trial and granting Hospital Exemption in Germany.
Here are some in RED right now...ACAD, AGEN, GALE, CTIX, VRTX, IMUC, PBMD, PPHM, WMT......
An update today from a multiple brain cancer survivor Jessica Oldwyn and UCLA Neurosurgeon, Dr. Linda Liau patient. Jessica is a such a remarkable story and incredible woman who blogs her battle with this horrific cancer over the years. Read comments section of her blog, she is such an inspiration to many and please pray for her as she goes through another surgery later this week for brain cancer recurrence.
This is why I am invested in NWBO and potential to help these patients from this just horrific cancer!
GLTA all patients, families and NWBO longs!
https://jessicaoldwyn.blogspot.com/2017/02/cant-fly-blind.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed:+Toom-ahWhatStinkinToom-ah+(Toom-ah+What+Stinkin'+Toom-ah)
Flipper...interesting and thanks for sharing!!
Al4door....it has been posted many times over the years but NWBO decided long ago to allocate their financial resources with DCVax-L in Phase III for GBM and its orphan drug designation in a cancer with an unmet need whereas there already were companies like Dendreon and Medivation gaining approvals for prostate. NWBO's prostate phase II trial had better overall results than both of those companies candidates and NWBO did not have enough $$ to run (2) Phase III's simultaneously let alone just trying to run one.
In addition, DCVax-L and DCvax-Direct can address prostate now....
Bingo abeta!!!! Doc logic has great understanding of CXCR-4 as it relates to what NWBO is doing with this patent. You can my highlights in your quote in bold!
abeta....Doclogic has posted numerous times on benefit of NWBO's CXCR-4 patent and benefits of it. I hope Doclogic sees this and will reply.
CDEL back again on bid at $.41 with 224k!
Quality Control Scientist - Biotech at Cognate BioServices, Inc.
Memphis, TN 38118
Job summary
Location
Memphis, TN 38118
Job type
Full Time, Employee
Salary
60,000.00 - 75,000.00 $ /year
Posted
9 Days ago
Industries
Biotechnology/Pharmaceuticals
http://job-openings.monster.com/v2/job/View?JobID=180706157&MESCOID=1900306001001&jobPosition=1
jd...what are you hearing? Something definitely building up here!
signs indicating something building here with recent shipment of (16) pieces of clean room biologic manufacturing equipment for Cognate, Cognate Buildout complete, Cognate $24M funding, NICE appraisal of DCVax-L for GBM and committee review completion tomorrow, 2/23 is connecting the dots here IMHO
I know they do....the manipulation is just so blatant each and every day!
BSB, just sickening how they continue to manipulate each and every day! I would send your screenshot to Les as it is so obvious what is going on here!
Great great post Flip!!
Great post and interesting points made!
You need to get your facts correct as Linda had not issued any PR on Swiss approval. Second link is follow up to Swiss PR
Agree...