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A14Door - No need to apologize - We ask for something different because we are not happen with the waste and corruption then when we get it we look to go back to the same old same old .
Its all about the policies ! Now if you don't like them complain
Amen ---- Can't wait for the day we can all meet and celebrate
Everyone will be trying to buy !!!!
LOL
Monentum2 -- It was just his/her opinion ! That's it
No reason to throw mud
Nobel-winning psychiatric study one day\\
I agree but on what side will the study be on?
People who are betting that DCVAX will be successful or
negative people wasting time here !
Why do they waste their time ?? One Chapter in the study
We know what Chapter I and you will be in!!!!!!!!!
JRII - Are you kidding?
All solid tumors -- I can make it successful!
Just think of the disruption this will cause, the demographics of the World, yes the World
It will affect Social Security -- Pensions --- Housing
yes - I can make DCVAX successful when the results show positive!
I'm not even getting into the improvements with DCVAX that will happen as the years go by. Vaccine is a breadcrumb !
SOS Stated that The MOS that received SOC was about 16.5 Mths
Chris your calling for 30 Mths - Awesome if your correct.
8 Month Improvement would be a Homerun !!!
So as we rehash other topics on this board I thought it would be a good time to repost some thoughts from the Jan 4th SOS article
SOS - Smith On Stocks
MOS - Medium Overall Survival
For myself and some of the New people that read this message board.
When News hits nobody will be able to keep up with the number of messages that will be posting here. So let's enjoy the article again.....
http://smithonstocks.com/northwest-biotherapeutics-issues-to-focus-on-in-pending-manuscript-dealing-with-unblinded-data-from-phase-3-trial-of-dcvax-l-in-newly-diagnosed-glioblastoma-nwbo-buy-0-23/
My Favorite Part:
Key Takeaway Points
Here are the key takeaway points:
I am expecting a manuscript discussing blinded data from the 331 patient phase 3 trial of DCVax-L in newly diagnosed glioblastoma will be published in a peer reviewed journal in the immediate future. This paper has been co-authored by most of the investigators in the trial.
The design of the trial allowed for patients started on SOC to receive DCVax-L if their cancer progressed. As a result, I estimate that: (1) about 221 patients were started on DCVax-L, (2) about 110 patients were started on SOC and roughly 76 of these patients were given DCVax-L when their cancer progressed, and (3) only around 34 patients received just SOC.
This trial is essentially a one armed study of DCVax-L. The results for mOS as shown in the expected manuscript should be an excellent proxy for what mOS will be when the phase 3 results are unblinded at some future point.
There is great deal of historical data that shows that mOS for SOC is about 16.5 months. As discussed in this paper, if the mOS for the blinded 331 patients shows a 2.5 month improvement in mOS (19.0 months versus 16.5 months), there is a strong chance for approval. The last drug approved in newly diagnosed glioblastoma was temozolomide in 2005. It showed a 2.5 month improvement over what was then SOC. Subsequently temozolomide was included as part of SOC and given to almost all GBM patients
Key opinion leaders consider an improvement of 4.0 month in mOS in an aggressive cancer like newly diagnosed GBM to be a major advance.
An 8.0 month or longer improvement in mOS would be a home run.
This data should also give an idea as to whether there is a survival tail. If roughly 25% of patients are alive at three years in this trial, this would compare to 15% expected with SOC. In other words 10 more out of 100 treated with DCVax-L would be alive at three years than would be the case if they received just SOC.
Why is that important? It is because the checkpoint inhibitors like Opdivo and Keytruda had survival tails like this in metastatic non-small cell lung cancer and metastatic melanoma which are aggressive tumors like newly diagnosed glioblastoma.
It is the survival tail of Opdivo and Keytruda (keeping 10 more patients alive at three years) that excited key opinion leaders and has led to these and other checkpoint inhibitors as a group reaching $9 billion of sales following their introduction in late 2014.
The mechanism of action of DCVax-L is such that it is reasonable to think that it might show efficacy in most (all) solid tumors-lung, breast, colon, etc. Newly diagnosed glioblastoma might only be the first indication.
A savage social media attack on the Company combined with extremely aggressive naked shorting has resulted in the stock selling at $0.25 per share. It is priced in the expectation that the trial will almost certainly fail. If DCVax-L is eventually approved as seems possible, this might well be the most amazing story ever told in biotechnology.
Let’s hope so.
Drug Price -- Here is another example of a new approval
A cutting-edge new cancer treatment from Novartis called Kymriah just got approved to treat more people with certain blood cancers last week, the drug's second approval.
The new approval — this time to treat large B-cell lymphoma — came with a new price tag: $373,000 for the one-time treatment.
OK - Two separate items:
First: many Many months ago it was stated here that in order to get a new product approved by the FDA that product must be better than the SOC.
One additional reason for extending our trials could be to make it more difficult for all of our competition that is following us to get approved. It could be at least a by product of the long wait to say the least! BUT make no mistake - the wait with no news is not easy.
Second: RMAT - Yes I needed to look it up and I thought others might benefit from the definition. Here you go !
Congress included several provisions related to cell and gene therapies in the 21st Century Cures Act, the most important of which is the RMAT (“Regenerative Medicine Advanced Therapy”) Designation. Sponsors of cell and gene therapies are now eligible to obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it could address unmet medical needs. Due to the recency of the RMAT designation, many people do not understand what it is, much less who has been awarded one.
The short answer is that the RMAT designation makes products “eligible for the same actions to expedite the development and review of a marketing application that are available to drugs that receive breakthrough therapy designation – including increased meeting opportunities, early interactions to discuss any potential surrogate or intermediate endpoints and the potential to support accelerated approval.”
For more detail, the following is from the U.S. FDA website:
As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:
The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service
Act and part 1271 of Title 21, Code of Federal Regulations;
The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition
Chris -- Do you agree with Kasey or Hamburger ?
I tend to lean toward Kasey - big time LOL
Bottom Line: Hamburger states that DCVAX D is not within Phase 3 so that the right to try does not apply but that could happen overnight.
So Hamburger is not looking at the big picture in my view
Your thoughts - while we wait !
First of all how do you know which treatment was utilized?
Second: He went with what his doctors suggested and DCVAX results are not out yet. Does his doctors even know about DCVAX?
Simple answers ---
YES - A very nice interest rate but she didn't have to place any of her money into the company!!!!!!!!!!!!! But she did !!
The company could of just sold some additional stock to the islands !
Which will not happen anymore !
Just using ASCO as a timeline
We really are looking at ASCO 2019 !
Aren't We ?
When I voted I requested an email notification of the vote!
Don't know when that will show up --
Spartex -- Today 2:30 EST
Excited to get through this day and see where we go!
Today's vote is just another task that needs to get out of the way
before we hear where the company and shareholders stand with Phase 3 results.
Hopefully the last item! And we get some news soon
They are right on our tail !
Immunotherapy Clinical Trial Reveals Brain Tumor Shrinkage, Continues with Phase 3 Study
https://www.yahoo.com/lifestyle/m/92108061-d46b-3a53-8c22-11902b8cc750/ss_immunotherapy-clinical-trial.html
SUMMIT, N.J., April 25, 2018 /PRNewswire/ -- Following successful Phase 1 clinical trials, the Toca regimen – a new immunotherapy for patients with recurrent brain cancer – has advanced to a Phase 3 study, which is currently underway. The trial is being conducted at 67 sites across the United States, Canada, Israel and South Korea, including at Atlantic NeuroSurgical Specialists (ANS) Brain Tumor Center, one of three clinical trial sites in New Jersey. In this surgical study, patients are randomized to either standard of care treatment or the Toca regimen. Enrollment is expected to complete in this trial by the end of 2018.
"Toca 5 uses a virus to stimulate a patient's own immune system and attack recurring high-grade gliomas – glioblastoma and anaplastic astrocytoma," explains Dr. Yaron Moshel, a board-certified neurosurgeon at ANS.
Patients randomized to the Toca regimen receive an investigational treatment that involves two discrete steps. During the first step, patients receive Toca 511 (vocimagene amiretrorepvec), a replicating virus that selectively infects cancer cells, at the time of surgery. After a few weeks, they then take cycles of Toca FC (extended-release 5-fluorocytosine), a potent anti-cancer pill that kills cancerous cells and activates immune cells selectively against cancerous ones, leaving healthy cells unharmed.
"Data from Phase 1 testing of the Toca regimen showed a favorable safety profile, complete tumor shrinkage, and extended patient longevity compared to other therapies," Dr. Moshel continues.
With the current standard of care, newly diagnosed patients with glioblastomas have a median survival of approximately 14 to 16 months. After recurrence, median survival is typically seven to nine months.
"In contrast, Phase 1 results of the immunotherapy trial showed median longevity of 14.4 months for patients with recurrent disease and patients with complete tumor shrinkage are still alive almost 3 years after starting the Toca regimen," adds Dr. Moshel. "These results are encouraging – for patients, their loved ones and the medical community – and we look forward to sharing further findings from Phase 3 within the next 18 months.
For more information, contact the ANS Brain Tumor Center at 973.285.7816 and visit ansdocs.com/tocagen.php.
For any new people that pop in here from time to time or that may post a little or maybe not at all. (Does that cover all situations LOL)
One thing is for sure, the information here will be amazing once we get some information from the company, it's easy to say this with all the talent here on this message board.
We have knowledge people posting info today and more importantly some of our experts have been on their own quite mode because they are just waiting for new info to discuss.
Amen to that Doc
I must admit I wish that I new what you were hoping about !!!!!
Here is a story on Sen McCain,, not much in the article but what the heck its new
Politics
The Sad Truth Behind How Long John McCain Is Actually Expected to Live With Brain Cancer
https://www.yahoo.com/news/m/3acf427b-830c-309d-b48d-a5c98bc027c6/the-sad-truth-behind-how-long.html
Germany's Merck seeks partners for cancer and immune system drugs
Reuters Reuters•April 20, 2018
FRANKFURT (Reuters) - Merck KGaA will seek development partners for experimental treatments including tepotinib as the German company looks to licensing deals to help fund clinical trials, according to its head of drug R&D.
Merck has a promising drug pipeline for the first time in several years. It is looking to take a collaborative approach, as an expected decline in operating profit this year forces it to find new ways to finance pharmaceutical development.
Luciano Rossetti, its drug research and development chief, told Reuters the company was engaged in "very intense ongoing conversations" over deals to help fund trials of drugs in its pipeline.
He said Merck was looking to strike agreements for treatments including oral lung cancer drug tepotinib as well as a so-called bifunctional fusion protein at an earlier stage of development, which aims to assist the immune system in fighting cancer cells.
WOW - I'm I the only one that's wondering whats going on and why it is positive?
Maybe to much fireball tonight but if anyone would like to simplify the explanation I for one would appreciate it. Anyone else in my situation?
Not Fireball but just confused
Tilt - Could not resist and bought more today -- Not that I needed the shares......
I'm Hooked
Tilt - A living breathing Breadcrumb !!!!!!!
CNBC just finished discussing BMY and MRK.
Karen Firestone (CNBC Reporter) starting to like BMY
Because the price continues to drop
I'm sure she would like BMY a lot more if they had DCVAX under their roof.
LOLOLOL
Naaaa Not from me !!!!!!!!!!!!!!!!!
My children are sleeping under the Pierzyna
Unfortunately Tilt you are going to get your chance to buy under .20
Always Drops during Lunch hour -- Go Figure
30 trading days left until ASCO.
Emotions are flying today !!!
The trended txt messages from friends and family will start shortly
I always thought:::
CI's to a limited point of the immune system
and
DCVAX unleash's the entire immune system
We are talking in general terms but aren't we talking partial Antigens versus Full antigens against the cancer?
I guess its just noise at this point, Just waiting for a summary of the DCVAX Vaccine to fight all solid tumors.
OK - sounds good with me
Back into my cave to wait out some news
Thanks to everyone here for all the work you do to place relative info here
Marzan -- I found their email within a news story. So I sent the info to their email.
I just followed up with an email of the twitter links that I follow:
Ex: Chris's Twitter lol
Hope its OK Chris
If I hear anything from the family -- I will pass on if OK with family
Take Care
When will spring get here ???
Here is the link to the CBS Morning segment
https://www.cbsnews.com/news/can-all-the-money-in-the-world-beat-cancer/
I just emailed the family and gave a quick explanation about DCVAX and links to patients and a link to this message board.
So behave yourself s -- LOL
I Pray that it will help their son !
Alan's
Kate's
Nate's
and Jeannine's Story
Put on Sunday Morning now
Brain cancer research
Look for link -- For the replay
McDonald's son (Arrow) with brain cancer
All the money in the world -- looking to help their son
They are from ---- Pebble Beach
Tried --- ANTI CD 47
Offered 10 million for a cure
Son Relapsed --
They went to Bezos for a 250 million dollar loan to cure brain cancer
Someone from the company needs to fill in Bezos
Les - Are you reading this ?????????????????????????????
There is always another story. ugh
I Hope we have some kind of break through
Syracuse QB Rex Culpepper, battling cancer, throws TD in spring game (Video)
Dr. Saturday Sam Cooper,Dr. Saturday 2 hours 6 minutes ago
Reactions Reblog on Tumblr Share Tweet
QB Rex Culpepper, currently between rounds of chemo for testicular cancer, comes in for the last drive of the Spring Preview & ends it in style with a touchdown pass!#RexStrong #SCtop10
Maybe they need the extra shelve shares for a take over defense?
Or a bargaining Chip ?
As good as any other theory right now
Don't know if this was listed here before but its kinda quite so here goes...
http://www.miamiherald.com/news/nation-world/national/article208671109.html
Rather than round up a patient's T cells and re-engineer them in a lab to find cancer (the service provided by the new leukemia immunotherapy drug Kymriah), this treatment harvests a class of immune "helpers" called dendritic cells. Using ground-up cells from a patient's tumor, researchers trained the dendritic cells to recognize and attack that specific malignancy. When these fortified cells were reintroduced into the patient, they passed on their training to the immune system's army of killer T cells and sent them into battle.
Among 10 women with advanced ovarian cancer who got injections of the personalized vaccine once every three weeks – along with the medications cyclophosphamide and bevacizumab (marketed as Avastin) – eight showed a strong immune response and were still alive after two years.
In a comparison group of 56 patients that got standard chemotherapy alone, only half were still alive at the two-year mark.
Among a second cohort of 10 patients who got bevacizumab and dendritic cell vaccine alone (but no cyclophosphamide), only 30 percent survived to the two-year mark.
The study's primary aim was to test the safety of the vaccine in combination with the other drugs.
Among these study subjects, as well as in subsequent cohorts of research subjects, the vaccine has been "so safe it's unbelievable," said study leader Dr. Janos L. Tanyi, a gynecologist at the University of Pennsylvania. At worst, subjects have reported brief bouts of tiredness or flu-like symptoms, he said.
The same approach may also prove helpful in combating solid tumors in different organs, Tanyi said.
If ever there were a cancer ripe for a more effective new treatment, it's ovarian cancer. As the fifth-leading cause of cancer death in the United States – and the most deadly of gynecological cancers – it claimed the lives of more than 14,000 American women in 2014, according to the Centers for Disease Control and Prevention.
Because there is no effective screening mechanism for ovarian cancer, it's often not detected until it has reached an advanced stage. For 85 percent of women in whom it is diagnosed, a combination of surgery and chemotherapy does not succeed in driving the malignancy into remission, and it recurs.
A personalized ovarian cancer vaccine is likely years away from widespread use in patients. Scientists will likely have to find a way to make larger supplies of vaccine with a limited supply of tumor cells, Tanyi said. Meanwhile, researchers are already finding new ways to enhance the vaccine's effectiveness, he added.
As in other immunotherapy trials, Tanyi has found that some patients were able to halt their cancer's progression with continued booster shots of vaccine. For some women, the vaccine appears to have driven the cancer into remission entirely.
Tanyi says he is eager to explore whether the dendritic-cell vaccine might also be used as a first-line treatment for women who are newly diagnosed with ovarian cancer. In order to supply tumor cells for the vaccine, such patients would still have to undergo surgical removal of their tumors.
Another one bites the dust
Pfizer Inc. PFE announced that a late-stage study on its kidney cancer drug Inlyta (axitinib) failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS). Accordingly, an independent Data Monitoring Committee recommended the study be stopped at a planned interim analysis. Detailed data from the study will be presented at a future medical meeting.
The phase III ATLAS study was evaluating Inlyta versus placebo as an adjuvant therapy for patients with high risk of recurrent renal cell carcinoma (RCC), a type of kidney cancer, following surgical removal of one or both kidneys.
Root -- A big NO for ASCO 2019
Count me for a NO !
Don't even bring this up ! -----
OMG -- where are my blood pressure bills ??? - I need to double up today
Interesting Headlines : This Lung Cancer Drug Could Let Patients Forgo Chemo—And It’s Sending Merck’s Stock Soaring
Call it “King Keytruda.”
I'm having a hard time finding how much the patient Life is extended.
Merck's CEO has not performed well lately, I'm skeptical of the headlines. Big Pharma pulling a fast one over the Press / Public ??
No tweets today Chris ?
Everyone seems to be silent on tweeter.
Hmmmmmm
Another one bites the dust
I guess we should raise our estimate for DCVAX to 2 Trillion
By the way: I'm voting my 310k as a YES
Just in case someone is counting
No matter of everyone here and their friends voted NO, it would still pass.
So lets list another 100 - 200 posts here talking about nothing that matters. (the vote)
LOL
NO - Don't give the enemy anything (AF)
Release the general data before April 25.
Submit General paper to ASCO (General maybe a bit more data) on April 25
Follow up at ASCO with a large presentation and have enough chairs for everyone before they fall down with amazement of the data.
And change the Cancer Treatment Industry forever!
Just VOTE -- Let's not beat it to death !
CEO just dumped money into the company, if you think they are going BK --
You don't belong in this stock
No matter which way anyone votes they will have enough vote to get the response that the company is looking for !!!!
Vote = Yes
I'm not happy with how long this has taken but
There I feel better !!!!!
45 minutes before the open and we have a trade for 6,500 shares
I'm not trying to allude to anything just surprised that we pre-market traded on the exchange that we are on.
Nice to be in a new month.
AVII - Does your daughter plan on working in a Hospital or Retail setting.
Hospital? I might be able to make sure she gets a second and long look at her resume. Midwest --- Notice just general statements.
Hint: I have been in your fatherly college position not that long ago.
That's a good point Flip --- a little more complicated that yes or no
I guess one good rookie way to look at it would be how the FDA would view that 20% as enough for FDA approval. Now the question is what is that 20%, over 5 years or better results. I don't know how the Doctor was looking at it in the video. If this question is a little to vanilla than forget it its ok.
I think that I will just craw back into my cave and wait for news from the company!
Thanks for all you do Flip and a good number of other people here also.
Don''t think I would be in the position that I am in without your posts.