Clovis Oncology’s Rubraca® (rucaparib) Significantly Improves Progression-Free Survival versus Chemotherapy in Patients with Later-line Ovarian Cancer Associated with a BRCA Mutation
Data from the randomized, Phase 3 ARIEL4 study to be presented today at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer
The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in investigator-assessed progression-free survival (PFS) for Rubraca versus chemotherapy
The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU product labels
 

ok even with your take on it , there's a level of collective consciousness about the power of vaccine now that was unthinkable a year ago .

People are no longer dying once they`ve even had the first dose ..

So to me that box is ticked, so you think he`s waiting a bit longer just to squeeze some more consciousness ??

I personally know a 74 year old and a friggin 24 year old currently trying to get the vaccine, if youre right Les is not just a pathological liar he`s scum of the highest order.

So Flip, what would be the benefit of waiting for public consciousness , considering its at least 1000% beyond where it was this time last year ??

If the trial had failed and he was counting on some public rebellion demanding the drug ... maybe ... but it has not failed .

I think you credit Les who is a pathological liar with being some master strategist, he`s not he`s just an old man (hard working admittedly) who's lies and obfuscation will , luckily for him , be saved by the science ..


Its buy out I tells ya ...

Over half the adult population have been vaccinated in the UK, we are well past the inflection point , lock down was all about protecting the NHS , and now the high dependency bed count is dropping off a cliff with
daily deaths yesterday at 52 with a moving average of 79.

The data's been locked over 6 months whilst they probably had the complete picture 9 months ago in my opinion and these delays to TLD are all about commercial negotiations with an acquirer.

My point was UK and that still includes Sawston last time I drove past it, is not in the EU .

69
Average age of our Board : 69

We aint taking anything to market, every move is posturing for buyout .


1)Linda F Powers Chairman/Pres/CEO/Interim CF 65
2)Dr Marnix L Bosch PhD Chief Technology Officer 60
3)Dr Alton L Boynton D Chief Scientific Ofcr/Secretary 76
4)Leslie J Goldman Senior VP/General Counsel/IR 75

True but many many exemptions when it comes to going to work , even I have been in my office everyday since last June .

Flip , I`ve been saying for a while data lock was PR'd 5th October , but when we the data actually locked , well before I`d suggest.

Sawstone has been in its current operational state (fact btw) for nearly 2 months and yet we only got the PR this week ...

Linda / Advent do not own any building in the EU .

which building in the EU ???

I`m retiring back behind the
red dot, I cant listen to any more utter rubbish ... I knew I shouldn`t have risked it ... ah well ...

Where`s Mr Accumulator.... a close at 62 and we've broken again ...

and Im pretty sure youre wrong :

AS AT RIGHT NOW

Jack ,
We all know who you are , you should move on .... again ..

OTC QB Companies by Market Cap :

there are 400m ++ shares slopping around and always shares available to borrow , there are no ` illegal ` shorts in NWBO .

Shares available to borrow RIGHT NOW :


Recent Data
Fee Available Updated
12.6 % 3,400,000 2021-03-17 16:45:02
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14.2 % 1,500,000 2021-03-11 16:45:03
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14.2 % 1,500,000 2021-03-11 15:30:02
14.2 % 1,500,000 2021-03-11 15:15:06
14.2 % 1,500,000 2021-03-11 15:00:03
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14.2 % 1,500,000 2021-03-11 12:45:03

If you read Hypers ` Merck - Pandion `piece, its a great explanation of what posturing goes on.

For us CRL , Avent build out etc etc comes under the same title ` leverage on final offer buyout day `

I`ve long said a deal has already been done and I stand by that.

..theres never been a significant shortage of shares to borrow, right now as we speak there are 3m +

We`ve been diluted to high heaven and even with 400m shares held tightly there are still 400m + sloping around in the system and that`s what makes out corner of the OTCQB swap feel more like quick sand ...

...and this will finally put paid to every message board and tweet whose stocks have been sold blaming `illegal ` naked shorts...

And none more so than ours but with ours the seeds have been sown by
an officer of the company to anyone and everyone that'd listen to him ...

`hundreds of millions of illegal shorts` LG .

So if he's been telling you all the truth, where are we going to trade tomorrow when the gamma hits $5 , $10 ....$20 ...

IT WONT MAKE A SINGLE CENTS DIFFERNCE TO US BECAUSE HE`S FOS, ALWAYS HAS BEEN ALWAYS WILL BE, BUT LUCKILY FOR HIM , HIS LIES WILL BE SAVED BY THE SCIENCE

I look forward to those members of the board that have spouted endlessly about the illegal shorts replying to me ...

OTCQB List of companies by m/c :

...one buyer to spend $20m is all we need to fly through $2

Bright Boy I know two people currently trying to get the vaccine and believe me North Wests constant delaying of data is far from putting smiles on their faces .

it will be on TLD day

Jeez great find TC - honestly this kind of PR will get at least one big player to pull the trigger..

Flipper & Soj : GAPS

We WILL fill the $8.84 gap

...to me ` coming months ` is the only thing they could say and I give it as much relevance as if they had said the `coming days`

I use the private client side of my bank in the UK

why don`t you ask them

Thats due t their direct market access set up .

OTC def trades pre and post

You`re over thinking.

I think that also .

oh ha ha I guess I should know that ...

1.74 trading on the pre ..

ha ha odious response ...

Yep , we are done ...
...not a chance they`d release that without everything being in place.

These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval.

Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK FacilityApplication for MHRA Regulatory Certification of Facility In Preparation
PR Newswire
BETHESDA, Md., March 16, 2021
BETHESDA, Md., March 16, 2021 /PRNewswire/ -- 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"). 
To date, the Company's production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 - 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor.  These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval.
An intensive recruitment program has been underway for well over a year, and has successfully hired and trained the necessary 30 senior technical managers, scientists and staff technicians and operators for manufacturing, quality control and other operations of the first two production suites. The recruitment process for experienced personnel with these types of expertise is highly competitive because the cell therapy and immunotherapy fields are growing rapidly and the pool of experienced specialists is very limited.  With the initial team of 30 specialists on board and trained, the recruitment and training are now continuing to expand the team.  When the Sawston facility is fully built out and in full operation, it is estimated that it will employ in excess of 300 highly skilled personnel, including many who may be trained through apprenticeships in the Sawston facility.
Since the initial dendritic cell vaccine production capacity will occupy only a small fraction of the total space in the Sawston facility, it is anticipated that additional capacity for third party production of other cell therapy products may be developed in some of the other space.  GMP facilities are capital intensive both to develop and to operate.  Third party production of other products will help support the Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility.  The capacity for production of other products will also be an important resource for the region.
Development of the Sawston facility has been under way for more than two years, and has progressed on parallel tracks in multiple areas, including physical buildout of the first two production suites, equipment procurement and validation, specialized operating systems, drafting of regulatory documents, and recruitment and training of key scientific and technical personnel for the first two production suites. 
All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.
The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages.  Each of these stages has taken many months of work.  In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.).  Those data then form a major part of the application to MHRA for certification of the first phase of the facility.  The Company currently anticipates that the PQ stage will be completed and the certification application will be submitted to MHRA within approximately the next six to eight weeks.
The physical buildout of Phase 1a of the facility was carried out last year, and was completed ahead of schedule at the beginning of October despite COVID operating restrictions, by having the contractors work double shifts and other special measures.  Advent BioServices worked with R.G. Carter as the general contractor.
R.G. Carter and its team of sub-contractors did an exceptional job of overcoming the COVID related difficulties and achieving the early completion.  For example, they enabled and managed double shifts throughout the project, worked out special operating arrangements to enable construction to proceed in a socially distanced manner, found alternate sources for specialized materials when the original suppliers were unable to deliver, and made special travel arrangements to bring European equipment vendors' installation engineers to Sawston.  The Company is grateful to R.G. Carter and its sub-contractors for these special arrangements and solutions, and is looking forward to working with this team on subsequent phases of the Sawston facility.
Phase 1a cost approximately £3.5 million ($4.6 million), including the double shift costs, and covered the support facilities for the first two manufacturing suites, which had already been built. Approximately £1.35 million ($1.77 million) of the Phase 1a cost was funded through a competitive loan from the Cambridgeshire and Peterborough Development Authority.  This funding was instrumental in enabling the Sawston facility to reach initial manufacturing readiness.  The Company is very grateful to the Development Authority for this funding, and is looking forward to continuing to work with the Authority.  
Following the physical buildout, the extensive and specialized equipment was sourced, installed, tested and validated.  The COVID circumstances posed a number of difficulties.  For example, there were supply chain and delivery difficulties to obtain the equipment.  In addition, foreign vendors were unable to travel to the UK to conduct the installation, testing and validation as would usually occur.  UK personnel had to go through training to conduct these activities instead of the vendor.  The data from the testing and validation of each individual piece of equipment is required for the application package for certification of the facility.  This work is now in the process of being completed.
Certain specialized operating systems (environmental management systems, quality management systems, lab information management systems and others) are required to measure, tightly control and collect data on air flow sterility and turnover, particle counts, and other conditions, as well as lab operations.  The sourcing, installation, testing and validation of these specialized systems also encountered difficulties due to COVID, but are now nearing completion. 
In parallel with the physical buildout, the equipment and the specialized operating systems, an intensive program has been under way to draft the necessary SOPs (standard operating procedures) and other regulatory documents.  SOPs are tailored to a specific facility and cannot be procured ready-made.  Detailed SOPs must cover every aspect of the facility's operations, from the time supplies arrive at the loading dock and are placed in quarantined storage all the way through to the release of finished doses of the dendritic cell vaccines to the physician and patient.  Over 500 SOPs and other regulatory documents have been drafted and tested over the last year-plus period, involving many, many thousands of man hours.  This set of regulatory documents is now essentially complete for the initial launch of product manufacturing in the Sawston facility.
As previously reported, the Company has also been moving forward on optimization of the Flaskworks system for manufacturing of dendritic cell vaccines.  The buildout of the Sawston facility is purposefully being done in phases, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage.  It is anticipated that implementation of the Flaskworks system will enable the buildout of some or all of the rest of the 88,345 square foot facility, beyond the initial manufacturing suites, to be simplified and streamlined at reduced cost.

Northwest Biotherapeutics Announces Development Completed for In
Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of
Sawston, UK Facility Application for MHRA Regulatory Certification of Facility In Preparation PR
Newswire BETHESDA, Md., March 16, 2021 BETHESDA, Md., March 16, 2021 /PRNewswire/ -
- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing

pick your level and stick to it and de risk what ever % of your holdings suits you but at least 33% and don`t worry about where it `might` go.

Greed made the fish oil AMRN brigade hold whilst it collapsed ...

def , and make sure you say ` good till cancelled `