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There will be swift approval everywhere once it's clear how well DCVax works.
If you worked with PEI then I worked with NASA lol
so you speak fluent German? I do
wie lange hast du da Gearbeited, was war die Nahme deiner Abetituilung, was war deine Aufgaben?
anyway, I called the EMA 1 year ago and 3 months ago about DCVAX L and its on their desk waiting for data input and the endpoints bought in, not with any local RA.
Also, my colleague supports drug business in getting approval with the EMA here in Amsterdam
Lol sure
Im not going to explain to you the principles of our European Union dude and how the working of drug approval in the EU.
But I will give you a few simple keywords so you have something for the weekend free movement of services and products + avoiding weak member states such as Malta + approval of expensive Cancer treatment in one state means approval in all states
now see Wiki
This is another reason why I believe that the FDA is the lead regulatory agency that is driving the DCVax-L regulatory approvals train by using Project Orbis to accelerate DCVax-L approvals in the US, UK, Canada, Germany and the rest of the EU, and also making DCVax-L a foundational part of the new standard of care (SOC) treatment for newly diagnosed and recurrent GBM patients worldwide.
thank you flipper I appreciate it
thank you for answering
I understand that is educational.
If the article would come anytime soon, then why is this article needed? Is Northwest still in the explanation phase of external control as we have seen for months with Dr Liau? If the FDA accepted, bought in the new endpoints then why is this article needed?
Answer positive
To not have to explain the need for external control in the DCVA article, this saves space in the DCVAX trial outcome article we will see soon.
To avoid attacks from shorters external-patients with DCVAX vs placebo-control
Answer negative
They still need to convince RA and scientists to accept external control vs trial.. and so it will take longer again
I hope its the first ofcourse
Our publication could be out on Nov 1. Sort of follow up to this article!
this publication in the Lancet today advocating for external controls in glioblastoma trials is wonderful news. Seems the work of advocating by Dr Liiau is being continued here. Question. Why?
If the scientific publication we are all waiting for is just a matter of a short time before it appears then why is it necessary to advocate for external controls in glioblastoma trials?
Why is it still necessary to advocate if the FDA has bought in and its game set match, done deal, in the pocket? That is a genuine question I have here.
thank you for answering
I think people have over active imaginations.
exactly
I truly hope LP will become a multi-billionaire I really do.
but we live in the here and now and I for one can only respond to what I see in front of me. But yes after TLD has met the endpoints no one including me will give a sheut and that is what she is counting on.
Like I said clever lady, she took a multi-ride on the good technology horse.
It was Advent that hired those 30 people the article speaks of, are you denying that?
Advent has from an ownership legal standpoint nothing todo with Northwest. Are you denying that?
If my family of 10 people would go to the barber, with government subsidy, every 2 weeks and that barber now has to hire extra help to service that extra business, did I or the barber hire that extra help?
Its completely irrelevant who got any subsidy, I was referring to the falsese notion that NWBO hired people, it was the Limited company Advent.
On this board left is right and up is down I suppose.
the Company is required to pay certain fees for dedicated production capacity reserved exclusively for DCVax production, and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. Either party may terminate the MSA on twelve months’ notice, to allow for transition arrangements by both parties.
it means a lot to me that you acknowledge my concern also raised by PM and jack. As you know I see you as the most important poster here.
I have the utmost respect for the science, Dr Liau and Dr Bosch, but I am struggling with this issue. I find it sincerely problematic that not all efforts and finances have been poured into developing the whole DCVAX platform.
Even though the PR makes it sound as though NWBO applied for the GMP certification, and yet Advent is supposedly the company that filed the application, accirding to MHRA correspondence.
I have a last question: Who will be the owner of the CERTIFICATE OF GMP COMPLIANCE of the manufacturing facility in Sawston?
Northwest Biotherapeutics, the owner of the facility in Sawston or Advent Bioservices, the CDMO who is also the operator of the facility?
"This initiative is expected to provide a significant boost to jobs in the region: 30 people have been hired for the initial production phase, with the potential for more than 300 employees when the site is operating at full capacity."
Anyway, the question on table is if NWBO is building out Advent. The answer is clear.
Anders might reply with Advent's balance sheet, but ignores the fact that LP can dividend cash out as she gets it it. So that means nothing.
Allegations of looting, and stealing, and conflicts of interest that violate fiduciary obligations,
Let me say it again: the relationship between NWBO and Advent is not in the best interest of NWBO shareholders, and it creates avenues for all sorts of potential shenanigans. It is wrong, and it should not be happening
give me a break, when any of us misses a single comma in our justified concern of Linda Powers the master in self-dealing you are all over screaming for evidence, which we then provide, but you can accuse a poster of in fact defamation and slander over a serious crime?
Measuring with two standards doesn't cut it more like not measuring at al..
You are being sarcastic and mocking the attempts of a concerned shareholder bravo, good for you well done.
From a legal perspective suing without the attempt of amicable settlements would be a very bad strategy and not well received in court. Of course, Jack has already said to have no interest in any lawsuits.
So now you’re claiming that CRL was robbed. 30 million paid to Advent, then it was just given to Toucan
Over the last 5 years, NWBO has paid Advent about $30M (not counting the spend for Sawston)
thank you jack for your contributions here on this board
I expect an ear-deafening silent or complete meaningless answer back, but who knows
This is actually even more complicated from a business perspective in terms of the long term disposition of those assets in the event that NWBO is sold. But different discussion.
I am not the one
do not wish to engage in a debate about this but if you look at the MHRA website insert-text-here
it clearly states that:
"To make, assemble or import human medicines, you need a manufacturer licence, issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).
To qualify for a manufacturer licence you need to show MHRA that you comply with EU good manufacturing practice (GMP) and pass regular GMP inspections of your site."
thanks sojo
well unfortunately the uptrend has broken?
You are twisting my words I do not appreciate that
Anyone saying that on Oct 6 Northwest has its first day of being too late to file trial results is wrong.
Standard submission deadline. In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.
The primary completion date on the DCVAX trial has come to past mid-august 2021 since it was mid-august 2020 and most probably weeks before that NWBO examined the last patient for the purposes of final collection of data for the primary outcome. In other words, Northwest is already legally late submitting trial results for weeks now.
Oct 5 has no legal meaning just a symbolic one
The video is wrong on several other points as well.
sosjo I agree with you on that. You are 100% right.
I will shut up about it but can't help myself if I see any more facts being turned and twisted on Advent
this is the first post ever you and I 100% agree on, its a small miracle :)
Advent doesn’t get a “license”, as has been explained numerous times,
I have a last question: Who will be the owner of the CERTIFICATE OF GMP COMPLIANCE of the manufacturing facility in Sawston?
Northwest Biotherapeutics, the owner of the facility in Sawston or Advent Bioservices, the CDMO who is also the operator of the facility?
Dear XXXXXX,
Thanks for the enquiry below.
The name of the company provided to us was ADVENT BIOSERVICES LTD which will be named on the GMP certificate once approved.
Kind Regards
Inspectorate & Process licensing (OA)
Inspection, Enforcement & Standards Division
Medicines and Healthcare Products Regulatory Agency
10th Floor, 10 South Colonnade, Canary Wharf, London, E14 4PU.
Telephone: 020 3080 6844
gov.uk/mhra
Making Advent a subsidiary only changes the ownership, it does not change anything about the company. If you sell me your car, it’s the same car with a new owner. And in the case of Advent, I wouldn’t even have to change the tags.
the email story is really touching. I will counter your story.. Les Goldman is the biggest BSer you will ever come across. He will tell you any nonsense you want to hear and you will walk out of the room or hang up the phone feeling good about your investment. He is really good at that. And that is not just me saying that but several large investors as well. But you are entitled to have loving feelings for Les.
I'm quite sure that LG and likely LP are really maxed out
I cannot see his posts but my experience of some on ihub is that are not prepared to read what’s in front of them and reach a conclusion before they have had enough time to even looks at any evidence….so basically it’s an emotional response and of no value….they didn’t believe the certificate was in Advents name, they don’t believe balance sheet accounts that show revenue streams from trade debt without any license other than to make DCVax-L on a small scale in a hospital room plus any fees to project manage the ramp up and they don’t believe the massive upside potential of Advent…..and then they question the motives of anyone who flags this up and don’t even see the value of Mgt actually confirming one way or the other how exactly NWBO investors benefit from Linda owning the very company with a license to make the vaccine…..”water off a toucans back”
The advent financial statements have been posted here more than once in the past
https://www.dropbox.com/s/ylmqkcku2jyjj7m/advent%202019.pdf?dl=0
This initiative is expected to provide a significant boost to jobs in the region: 30 people have been hired for the initial production phase, with the potential for more than 300 employees when the site is operating at full capacity.
Are you saying that you are *shocked* that NWBO claims credit for the staff who are actually working for Advent under contract with NWBO only employing them indirectly?
Northwest Biotherapeutics creating 300 Cambridge UK jobs
You guys have been wrong about the few facts we do have except for Advent being the name on the pending certificate and long on innuendo-type guesses
Are you saying that you are *shocked* that NWBO claims credit for the staff who are actually working for Advent under contract with NWBO only employing them indirectly? Would they be there without NWBO?
What ?? ...if I thought that I would have said it .
thanks, BSB very interesting