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Blue - The automation of DCVAX brings the cost down !
Pharma's are not afraid of any cost -- some of their charges are crazy high for their current treatments
Anyways Linda stated multiple time that they would like to have a lower cost so everyone can seek treatment....
All solid tumors ----- Big Revenue no matter what the cost
Yes the home run is in LP's eyes not big Pharma's that will try to influence the FDA. She is trying to take the influence away from Big Pharma !
End of Story
We Wait
A Clock is right twice a day
AF is betting on a 50/50 ratio
Better rates then u can get in Vegas on the tables
right far more often - means that he is wrong a good number of the times.
How can anyone disagree --- He has some large calls that weren't correct
He is as good as a Weather Man
Maybe Les didn't think that he needed to file ?
Maybe something was to be executed before the deadline making the filing useless - Waste of money LOL ?
As good of a theory as any .......
This will make a good movie some day @#$%^&*()+_(*(*&^%$#
If we are going to the Pinks and there is a symbol change -- is it the same thing as if we changed our name?
All shares have to convert to the new symbol and a new cusip number or whatever the number is called.
JUST ASKING
Awesome Post Flip
I don't know how you put this together -- I copied your post in case the delete police attacks.
I need to show this to all my people that are invested !
Tilt - you should Tweet that post
Thanks again Flip ! -- Great Work !
Time Fly's - If we don't get some news this week(doubtful) nothing will come out the week of July 4th so we are looking at the week of July 9th
LOL - I'm just going to get my mind straight Luke and keep August and November on my radar !
Thinking of pulling back just a little late summer !
Those cook county taxes are killer ! Viva Illinois - A great place to live if you like to pay taxes
BSB - If Linda made a move like the one you are talking about - I would start to Add to my position again !
Rename the company and Issue new shares -- what a great move to screw the shorts!
Let's pass some time and come up with some new names ! LOL
Pretty much the same trading pattern all week! -- Maybe multiple weeks LOL
Another week down the drain but closer to ------- something !
Root I agree -- Which Big Pharma is going to watch their competition get a hold of DCVAX. And if they do they are going to go down hill
We complain about all the time it take to go to FDA but all this extra time makes it harder for the next solution - They have to beat our number of months in order to take over the SOC. We will remain the soc until someone does better.
We continue to grow our number of months so we will be King for a large number of years .
The only worry I have is all these big Pharma Exec belong to the same country club ! If you know what I mean.....
Which one will break ranks and reach for the Gold ! And make their company Number 1 with the treatment of all solid tumors.
Markets closed any follow through Tilt ?
Whats UP
Just checking
Beartrap your scaring me -- On the phone with Etrade right now to make sure I do not have a margin Acct.
They have two entries for my stock - one is a margin acct. I asked this to be eliminated one other time.
They are going to put my stock together and eliminate the margin
Thanks for brings that up again
Off the phone now - takes a couple of days
They did say the stock was shorted at 8%
So have a great weekend - Happy Fathers day to all the Dad's
My Guess: Its going to be a Cofer Monday!
And if I'm guessing correctly - what do we expect the Price to run up to.
Trades today are one sided on the ASK
500k at the ask traded and 117 K at the Bid
And that's not counting the last 150,000 shares traded at the ASK the last few minutes in 3 trades
So add another 150k to that ASK
And for some reason they take that video down -- I made a copy of it when it was live so I have every statement!
Isn't this message board terrific ? --
Now, Don't make me Leak !
Story on Merck's Keytruda just came out -- Only talking a few months
UGH --- DCVAX Rocks
Merck said Keytruda trial patients lived for a median of 6.4 months before their disease worsened, compared with 4.8 months for the chemotherapy-alone group.
Rival Roche on Saturday said a trial of its immune therapy Tecentriq in combination with chemotherapy showed that the drug delayed progression of squamous NSCLC by 6.3 months, compared with 5.6 months for the standard chemotherapy combination.
https://www.cnbc.com/2018/06/04/mercks-keytruda-shown-to-extend-lung-cancer-survival-in-2-trials.html
These patients are awesome - Go Alice !
Nope - everything working great from presentation
Being very careful with there statements
Do Not want to make FDA or any other organization angry from the presentation
The one thing that I was surprised about the RTT bill was companies do not have to contact the FDA at all to decide if they which to give there treatment out.
The decision is up to the companies -- FDA is out of the loop
All they do is monitor
This was right from the Commissioner last week on CNBC
There will be NO problem getting the word out..
Here are a few posts from Kat's FB
Vishal Thakrar Hi Kat, hope you're well. Heard your story on BBC and just wanted to say congratulations, you are so lucky and fortunate that the tumour has gone. My mum has glioblastoma, she's had the operation, done the radiotherapy and is in month 10 of chemotherapy. The tumour has started to grow. I am really interested in how you beat it, any tips, the vaccine and how it all went overall. Is it possible for you and I have to exchange emails or have a call? Vishal Thakrar
Joanna Martyna Ejma Kat,please tell us how you got the vaccine and how much it costs?We are from Poland and I am looking for anything that might help...this is my email:martynapl@hotmail.com,you write to me on messenger as well,looking forward to hearing from you!
So we are the last presentation of the day inside the theater!
There should be no rush to leave the stage for the next presenter!
I hope we see Linda giving the wink to the man in charge of the room to let it go a little longer !
You can leave the reason why!
Awesome - interview Senti -- Only available for 27 days so I made a copy.
Thought we might have pictures from this year booth by now !
Maybe Later?
Which companies are going to end up on the outside looking in because they waited to long to work with us? And which company will be forever grateful because they will be on the top of the cancer treatment mountain for decades to come.
Crushing their competition!
Big Pharma are you reading this post?
The companies that wait will be CRUSHED maybe for good !
Get you Good Bye excuses ready for your stock holders
I wonder if Senator McCain seen the news today and the wife of the other senator I forget her name .
Thanks for the link -- I caught the last 10 seconds
I'm getting not available in my location
Oh Well its OK
Can we watch it live or later in day
Is the BBC segment in 10 minutes
time now
5:50 PM
Tuesday, May 29, 2018 (GMT+1)
Time in England, UK
To the Docs or anyone else: Through your experience how long does it take for REMICADE® to show some signs it is working? (Bad Colitis patient)
If it does at all! Chris?
White - Everyone knows the President needs to sign the bill.
He was waiting for the Congress to approve.
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 !