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dont you ever sleep? its 5.19 when you wrote that?
but the GMP certification ultimately belongs to the facility
I was kinda being cynical because unlike you, as you know, I have been amazed by the botching ways management has fulfilled its duties. Of course, the certification of the Advent Sawston facility has something todo with Northwest, it will produce DCVAX L, but in the 2X PR's last spring NWBO made it sound, and I find that kinda misleading as if the Sawston certificate would fall into the hands and be in possession of Northwest which it does not. If that would have been the case then Northwest would have become the CDMO for L herself. But the certificate to run Sawston will be owned as an asset by Advent and not Northwest.
So NWBO PR's the achievement of another company which has as much todo with NWBO as any other supplier for a listed company TWICE but does NOT PR its own truly remarkable achievement which has everything todo with NWBO?. That gets me cynical.
Why does NWBO not PR the achievements of CRL in Europe? They are making great progress? An why not that of Nespresso their supplier of coffee? Ooh, wait the CEO of the listed company NWBO does not own Nespresso or CRL but does own Advent, silly me. So it was her (LP) and his (LG) own personal private celebration last spring via NWBO website that was celebrated with two PR's but Dr. Bosch's achievement, actually working for NWBO, has now been forgotten?
I now have a question for you. Why does NWBO not PR the achievements of CRL/Cognate (such as their expansion in Europe) on their website? They are able to produce L even in even larger quantities than Advent Sawston after certification can..
They are months away from having an operational CDMO.
And Cognate was supposedly worth nothing without NWBO. Yet the owners cashed out for $800M or whatever a year ago.
PPHM had a single drug. They failed the P3 trial with nothing in the pipeline to save them
Agreed. According to ex a failed trial bringing the SP to zero and bankrupting Northwest is not something the average investor apparently would like to know lol
I was not referring to NWBO specifically but mentioning this in general, which, by the way, does not exclude disclosed statements by the biotech company made prior to data lock.
if data is worse than what the company, even in save harbour and as a forward-looking statement, has investors previously let to believe then that for sure requires the company to disclose.
Lol more text book burning?
Disclosure, and the manner of disclosure (whether in a Form 8-K or quarterly filing, etc.), are 2 different things, as are best practices. I personally would file an 8-K immediately after a failed trial. Below is another post that I made that give more context on my point.
100% agree
That's what I have been saying here all along, but some want to believe CRL has 100's of staff on stand-by twiddling their thumbs waiting for NWBO to give marching orders. Its only so many time per day one can make fresh coffee lol
You can’t say a failed trial would not be material enough to be disclosed within 4 days, but a mfg contract wouid be. It fails the smell test.
I can't speak for Ex, but the concern that I have is that there's not currently an agreement in place with CRL because FDA approval is either uncertain or still very far away.
I don't mean to suggest that CRL would refuse the business, despite NWBO's past issues paying their bills.
very good point
Perhaps the potential buyer indicated to want to negotiate the production of L on a larger scale themselves with Advent/CRL and are subject and can only start after topline data + publication. One is in a much better position negotiating the production of L if for example its also known if rGBM is in the picture or not and how good the data is.
I have never understood ex's point. Even it was true that a larger contract for production is not in place at present then why would CRL/Advent not want to enter into such agreement after TLD when they can. Why would they want to refuse that business?
and I want world peace but sometimes you have to realize you don't have any influence on bigger things then yourself
What we are seeing is the official patent publication of the patent application that was allowed in May.
sure NWBO PR the request for certification of the Advent Sawston facility 2x last spring which has in fact very little to do with Northwest itself but do NOT PR the acceptance of this patent which marks an incredible achievement in the field of inducing dendritic cells to combat cancer.
What was it DI said something about not hyping NWBO with unnecessary PR's?
Well done!
marzan your never-ending optimism is great and the beauty with optimistic people such as yourself is that they will be right one day hopefully today
This patent alone is worth billions Kypee; flipper has been counting on the allowance of this patent by the USPTO for sometime.
what do you think Sojo will SPY gap down some more or fill the gap it left today first before heading down?
thanks
Don’t start Posting facts here now ex it does not fit the Disney fans propaganda lol
Advent Bioservices is currently in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site.
Fully agree wel said
Ah now I understand the difference between Advent and Sawston
a lot of words to say that you dont know
Advent can have 59,999 facilities licensed it doesnt matter for facility nr 60,000 they need to request a new license with the MHRA
you have never answered a simple question and obvious why you never answered
who..... do you think...... requested/submited ..... the license .... to operate.... the Sawston facility..... to produce .......Good Manufacturing Practice (GMP) clinical grade medical products for patients?
A. Advent Bioservices
B. NWBO
Reply with a Simple A or B
None of this is brain surgery.
You keep on the same theme. But we hire Advent to get the site certified. Just as we hire independent testing labs, universities, consultants indirect and direct.
You are wise
I have said the last thing now about this subject as well :)
Auditing a building and assets without any employees is as rare as rocking horse poo….
but you are wrong if you think that the license is not tied to the facility and the process
That company/organization submitting the request for a license for Good Manufacturing Practice is either Northwest or Advent Bioservices for the Sawston facility.
I think NWBO shareholders deserve an explanation of how that benefits us
I certainly hope for the buyout option. Maybe the buyer requested a publication in a major journal to complete the transaction...
with the MHRA and any RA's only a business/organization represented by a person can submit a license or permit. The business needs to be registered with the chamber of commerce (companies house in the UK) and needs to be acknowledged by the tax authorities (has to be in possession of a TAX number). The MHRA needs to hold someone or a company liable or responsible if something would go wrong during the Good Manufacturing Practice and can't, and I can't even believe we are having this discussion here, hold a property responsible for Bad Manufacturing Practice.
Organisations that may have to comply with good manufacturing practice (GMP) and/or good distribution practice (GDP) include:
manufacturer licence holders
wholesale dealer licence holders
blood establishment authorisation holders
non-UK sites employed by UK MA holders
MHRA carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically based on risk assessments. Overseas manufacturing sites are also inspected.
If an organisation manufactures or distributes both human and veterinary medicines, MHRA may carry out an inspection of both areas on behalf of the Veterinary Medicines Directorate.
It is the SITE that gets certified.
I have said 12 times yesterday that they are building out the Sawston property even posted the link to the March 12 PR 2x yesterday quoting NWBO to you so you are fully informed.
There is no software really able to translate the nonsense that you believe in, into reality.
Since it is Advent that gets the MHRA certificate for the Sawston built out and like another poster said you cannot certify equipment and a building but you can certify qualified staff, its in fact Advent that gets built out. You do realize that Sawston doesn't mean anything right. You do realize that Sawston is just a business park, area in the UK?
Try using Google maps!
got it thanks, (was just a train thought on my part)
And the value is in that certificate.
200% agree
was it you or someone else that said that if a shareholder's interest is aligned with LP interest then you are fine. That posts should be stickied.
LP first and foremost interest is LP. Having said that I still believe she will be a billionaire and with that many shareholders will benefit and Im fine with that. But this is what do I call it this defending LP as if she had any interest in shareholders' value here, is absurd.
You have not called the MHRA have you? Your only act of bio investigation is this board isnt it biosectinvestor? Its people like myself and BSB and others that actually make enquires do investigation outside this board and call the EMA or MHRA, not you.
BSB CALLED the MHRA and he told me, ask him
The certification and all of the procedures as well as the facility, ALL belong to NWBO.
this is starting to get to a point where its propaganda pushing the big lie.
Advent is not certified
People love to tell funky stories.
hahahah the CEO of Advent is our smart ass Linda Powers so I would not be surprised that her name will not appear on the certificate but the COO.
What makes you think that is the case?
https://find-and-update.company-information.service.gov.uk/company/08717711/officers
1 officer / 0 resignations
POWERS, Linda Fairing
Correspondence address
7513 Connelley Drive, Suite 1, Hanover, Maryland, United States, 21076
Role ACTIVE
Director
Strange enough, Advent lists its COO but not CEO.
Advent if you have not figured it out yet, will be MHRA certified and receives the certificate for the Sawston build-out, not NWBO
And I know Sawston building does not belong to Advent it belongs to NWBO but do you know that?
Yes Im calling the built out of Sawston an Advent build-out since its Advent that receives the MHRA certificate which is the whole point
I know that dont be so serious. Of course its through business a lot of business that has been provided by the CEO of a listed company that privately owns a big chunk of a company she assigns manufacturing orders to from that listed company. I know that.
but we stil dont know how much Advent is paying NWBO for the facilities they provide now do we, so there is that unless yu dont call that financing
NWBO is not building out Advent
Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority (“MHRA”).