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Skitahoe.
The main reason for the ASM meeting, that we know of, is to reaffirm the compensation of the Executives. Do you think that maybe there is an agreement between NWBO and a BP or large investor and the timing of the ASM is to get a positive vote, and then the Judge's dismissal of the lawsuit before said agreement of can be finalized? Maybe someone that wants to get involved with NWBO after approval but does not want the garbage of a pending lawsuit as part of the equation.
They sure did not do a trading halt on May 10, 2022.
This is very interesting video to listen to from a UCLA chief investigator of one of our trials:
https://virtualtrials.org/video2024.cfm?video=202404
Day after Presidential election.
Open the Link and go to Acknowledgements on the top bar. Northwest bio is there.
Seems a lot of NW Bio D vac articles are coming out recently I have not read.
Have you looked at the "Acknowledgements?"
https://www.med.upenn.edu/brain2024/
I love Math and I will take a stab at it.
A 2 step process.
You take the 1st day of spoofing and run a chart of the share price up to the time and trades in the day of spoofing is documented. At this point you freeze the share price till spoofing trades have ceased. (say from 9:30 AM til 11: 00) At 11:00 AM you resume your chart of the share price. this gives you an end of the day share price minus the spoofing affect price.
This would give you a new closing price for the next days share price. (May be .01 or .02 cents higher). You do this for the entire 5 years or all of the spoofing trades documented and you come up with a share price to date WITHOUT the effects of spoofing. Cumulatively $$$$$ higher.
The 2nd step would be calculating the difference of the price on the date of every dilution sell by NWBO to "kept the lights on."
Example 5,000,000 shares sold in May of 2019 at say $0.80 cent. If price at that time was calculated to have been $1.20/ share, the difference would be $0.40 cents X 5,000,000 shares.
This gives you 2 areas of monetary damages. 1. the difference in dilution prices and the difference in the share price that it should be today WITHOUT spoofing.
It is simple Math and numbers do not lie.
I am sure there are other areas of price damages that could be argued in court such as public opinion etc. but that would be argued with precedence of past court rulings on spoofing cases.
Hope everybody has a happy and healthy New Year
Vator
Years ago I do remember reading a post that the reimbursement to Advent was Cost + 15% for production of DCVac. Whether this was an opinion of a poster or an interpretation of an actual contract, I can not say. Sounds reasonable to me. Note also in the 2022 ASM there was mention of ongoing negotiations with CRL (Memphis) for manufacturing was we have not had any update on.
VLMG17 Is your news on TDA a year old? Mine is and have got no satisfaction from TDA via an E-mail. They blame it on a 3rd party.
I email TD Ameritrade because my new reverted to over 1 year old news. Their reply was a Glitch and was looking into it. Told them I was not happy.
All true on the ownership as stated but the question is who owns the MIA (NWBO or Advent) and is it transferable in a sell of the facilities? Building lease. equipment etc. are only depreciated values without license to manufacture and ship.
Your thoughts on the SOC in the future.
If the new SOC for GBM will be DCVax-L + poly-ICLC, does that not move the bar higher in current and future Clinical Trails? Are we not looking at an mOS that is much higher to achieve?
What will this do to the ongoing trials in process right now and future Trials?
What will happen to the enormous amount of ECA data with Chemo as the SOC to compare results of a trial to? Will it all be obsolete with the new SOC for GBM being DCVax-L + poly-ICLC?
This seems to have the potential to be very disruptive to the Bio industry's future.
Even today, pre-approval, we are comparing ongoing competing Clinical trials to DCVax-L TLD results. TIA
Poor Man. Sadly on this board you would be wrong. The Oblong & Oval Society would present statistics to prove you wrong.
Moral of the Story is "INTENT' of what is said. PR and ASM statements are meant to be interpenetrated as to Intent.
In reply to this: "something which NWBO said they would issue upon submission of the MAA."
I think that a poster on here relayed this from his remembrance of a conversation with Dave I.
There has not been a PR on this subject from NWBO. Mater of fact the language from LP at the Dec 2022 ASM can be interpreted to contradict this.
EX
I was not aware of a SOC for rGMB that was the PH3 placebo arm which crossed over to DCVax treatment as required by the FDA. What is unethical is to just let them die to produce numbers on non-survival in a trial when we have a tremendous amount of historical data.
Was going to post yesterday on the same dates from my sources, but did not want 1/2 the board agreeing and 1/2 not. LOL
AE
Is the reason for the delay in the MIA because the application for MAA has not been submitted per LP's on words on the ASM Dec 30, 2022?
The way I read some of these post is MIA will not be approved until application is submitted. I am very confused now on the time frames of approval.
"The manufacturer license will be granted first providing the product is in the process of being approved."
Vator
I know you are long and have a problem with the way management runs this Company. Please explain to a lay man what could have been done to prevent May 10th or maintained the $2.00+/- share price.
PS I was a share holder and saw a 600K drop in value that day. TIA
Skidahoe. Most of the "projected" deadline have been imposed by this message board. Show me 1 definitive deadline date in a PR from the Company. We are at the mercy of and on the schedule of the regulations right now.
Bio
Thank you for the reply and I agree with what you have stated as fact. You are right, I am speculating. I do believe that Flashworks is a critical part of the future of NWBO. I will go back and listen to the ASM 2022 as to Linda Powers comments to refinement of Flashworks in Sawston & Boston.
As Linda said, if you want something to happen today, you need to have started working on it 2 years ago.
When ever DC Vac is approved by the RA's (1 or all), the demand for it will be tremendous. Thus the ongoing MIA in the UK and the negotiations with CRL in Memphis.
Thank Again
skitahoe
Your post got me to thinking that the perceived delay in MIA approval is not for the manual process of production of DC Vax. This process has been refined, studied and used for years at multiple sites for the trials and compassionate use. There is something "new" to the production process. The delay is the incorporation of Flashworks into the manufacturing to meet future demand. Reference Linda Powers comments in ASM 2022 on December 31, of different flow rates etc. to produce the same results as manual production in a Flashworks unit.
Remember "Laser Focused"
After the ASM, I am pleased that everything with NWBO is moving forward, but I was left with 1 sad thought in my mind.
I know the RA's are there for the protection of the public. But I was struck with all the enormous amount of paper work, inspections etc., and TIME it takes to approve a new drug or vaccine. If 10 people had died and 100 had survived because of a clinical trial they would have been shut down immediately.
Let's take the UK only and GMB only. 12,000 GMB cases per year. A conservative 20% survival rate with DC Vac, That is 2400 patients that would be alive in 2 years of the approval process!! How did we get to this point? Remember scientist and doctors with PHD's have got this vaccine to the point of consideration by the RA's not snake oil sales men. Seems as if these all powerful, self-important agencies have gotten out of hand and are a determent to the advancement of medicine. Please do not crunch the numbers with all solid tumor cancers in 2 years all around the world.
Somebody restore my faith in the system for the new year.
Cherry
But in a buy out to 1 BP, DC Vax is limited by that BP to use with only limited combinations and possibly not the best for a particular cancer.
DC Vax being use in combination with multiple inhibitors by multiple BP's is many times the revenue and benefit to the patients. And in the future, part of the treatment of other cancers besides GMB with direct.
Would somebody on this board tell me why a BP would buy NWBO when the Doctors can prescribe or set a regiment of Ketruda (approved by FDA) and DC Vax (when approved) as treatment like writing 2 prescriptions for the flu.
These vaccines are not combined into 1 vaccine. Matter of fact given separate by approx. 2 weeks is proving to be most effective in DR L's studies.
Clinical trials with other BP's in combinations for best results, YES.
DC Vax will be only a part of the new Standard of Care in combination with existing drugs or new inhibitors to be studied in trials.
I am Long from 2015 and will stay that way till bankruptcy or RA approval by the FDA (after UK approval).
When NWBO bought out Flashworks, was the unit not al
ready approved in the US? Did we just buy a Patent on a concept. Could somebody please expound on this
I was listening to the video live. 1 of the 600. questions were submitted and then asked by Al M. to DR L directly. No other names or persons were given. Al M. did not get to all the questions in the time frame as it was.
The JA review was only a "trial run" of the RA review.
Same data to be reviewed.
Same medical professionals on both review boards, so odds of approval just went up.
Do not over think this, Keep it simple,
Skit
I could not agree with you more.
Embargo = Doctors, clinical trail scientist and authors not commenting before JA is published.
Quite Time = Self imposed PR freeze by NWBO in regards to the Regulatory Authority approval so as not to jeopardize the process.
Keep it simple. I hold until there is RA approval by all 4 agency. Till then, ups and downs in SP will continue.
Sawston will service the EU and someone like CRL in Memphis will produce by contract for the US & Canada.
LP will NOT sell out at this point if ever.
Sorry, but the people (Longs) on her sound like that TV commercial.
"It's my money and I want it Now!!!!!"
Grip
We are not talking about a diet drug for weight loss here. We are talking about Insurance Companies denying Chemo & Radiation (present SOC) for a cancer patient. How many times is that happening now?
BIO
Of course there will be a resection of the tumor to create the DC Vax, but is that going to be followed up with radiation & chemotherapy?
I totally agree with you. They have released info, just not anything to do with the DCVax data submissions to the regulating authorities. UK in particular. The info we are getting PIP and manufacturing build out requirements are from other regulation authorities.
UK approval very soon
Germany shortly there after
US and Canada after
After UK approval you will see a SP jump that most people on here will sell at and big money will start buying. JMHO
To All:
Their seems to be some confusion on this board as to:
Embargo - Imposed for the JA by SOC
Quite period - Self imposed by NWBO with regards to the RA submissions.
PROVE ME WRONG or EDUCATE ME
Poor Man. I have consulted my CPA and she advises that you maintain ownership/possession of your park bench until after next week because you are going to need all the tax deductions and depreciation you can get!!!
Thank You Crash. That is exactly how I see it.
I am confused. Is the self-imposed quite period in reference to the JA or because of the submission of data for review to the 4 regulators. NWBO has only 1 author/employee (Bosch) on the authors list. Other than that, the Doctors are sharing "New" trial results with the medical community.
The top Brass at NWBO have decided at the end of the PH3 to remain quite till approval and that time line is well beyond their control as we have experienced. The only communication is what the Regulatory Authority in the UK has told them to accomplish. Being able to provide the product (DCvax) to the medical community of the UK and PIP trial.
To me, dilution is keeping on the lights, required expansion, and new required study trials (PIP).
I really do not see how anyone can not think this product will not get approval this week or this coming year, it will happen, but it is in the hands or others at this point.
I am not her for the short term. I will be here till I lose it all or it will be a life changing event for my children and grand kids. If I lose it all, it will not change the rest of my life as I am a simple man.
I believe there is now a limited number for submission. From a past post.
Just a thought, Could the 50 authors be some of the doctors in the PHIII at the 84 clinical sites around the world?
"my reading between the lines is: the application for approval was submitted months ago."
I agree with you on the submitting months ago.
In the UK, would you build a factory to produce a product before you had some sort of commitment of RA approval?
What would NWBio do with Sawston if the MHRA was not going to approve DCVAX for commercial production?
MHRA requires the ability to produce a product for the future demand either by NWBio or a subcontractor.
Everybody is looking at the individual tree instead of the forest.
Hope I can add another 200k and sit back an wait till UK, Germany, Canada & US approve DCVAX.
Mean while if this thing goes bust, the grand kids are going to have to work for a living and I have my bench reserved next to Poor Man or the grand kids will still will have to work for a living but not as hard as I did.
Bear & BIo
I believe I read somewhere that the lysate from the original tumor could be used for reoccurrence tumors. Frozen storage of the orignal tumor would be for the life of the patient.