Flipper44,

I took a picture of the graph and counted the colored dark pixels. Maybe this is not the right way to do it, but I count 26 censor marks.(Start at the first vertical censor mark above the median (dashed line) and count all the way to the last two censor marks to the left of AVII's red line)

Flipper44,

I think this is NOTE (5) Beartrap 12 post 171261
Quote:
________________________________________
Me: PFS progression, did we find people who had not really progressed but because of pseudoprogression, were put down as having progressed?

Linda: I'm not sure where you're getting that from ...us going through this or that process.
We haven't said anything publicly about PFS or progression. We haven't talked about having gone through this process or that process. We haven't spoken about the subject yet. That's something will be... that lies ahead, that we will be speaking about in the future. But not that I'm aware of, we haven't spoken about it yet. So you have to stay tuned.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140499659

Flipper44,

You wrote:

“Remember, one of the reasons I don't think there is likely much crossover impact in the current phase III trial (barring midstream manufacturing modification) is that the vaccine for crossovers will be based on the original tumor, not the recurrent and/or progressing tumor.)” (post 173725)

and you wrote:

-“Yes, hence why I see less chance for big crossover impact in the phase III trial (unless there was midstream optimization)”

-“(If there was a more potent version of DCVax-L created midstream, the more potent version might be able to help original placebos more. les is saying, apparently, off the record there was no midstream optimization in manufacturing.)” (post 173776)

But at the ASM ( 27 April 2018) Les Goldman give us the impression that everybody who is getting the vaccine is living longer! (See Notes 6 Beartrap12)

Quote:

“Les: I think its important for everyone following us, to take a step back and look and say, it can't be a bad thing if everybody getting the vaccine is living longer. So it becomes a question that with all the new policy initiatives at the FDA and overseas, how do our facts fit into this and as Linda says, it's still a work in progress to find the exact right slots, but the bottom line is if we have something where everyone who's had the vaccine is living longer, that's a pretty good thing. We shouldn't lose sight of this in the context of all the rules that used to be, and might be and are gonna be. People on the otherside of this would like to use that to camoflauge the reality of what may be unfolding.
Linda interjects “it's a maybe and we don't actually know for sure.”
Les: We don't know for sure.”

Flipper44, can you explain your point?
Thanks.

Flipper44,

I don’t know how important tangential flow filtration is but i saw these recent job description-Process Engineer-Gaithersburg, MD

posted : May 14, 2018 (Lentigen Technology Inc., a Miltenyi Biotec company)

Note: the ClinMACS devices are developed by Miltenyi Biotec company.

Experience Preferred:

"-Experienced in one, or both, of the following areas: o Bioreactor based production of biologics incorporating batch, fed-batch, or perfusion modes o Purification methods that include harvest clarification, chromatography, tangential flow filtration (TFF, UF/DF)."
https://recruiting.ultipro.com/MIL1021/JobBoard/f16cc611-8d8b-48fb-b086-24d10e2b6d21/OpportunityDetail?opportunityId=45317f5c-3319-4c42-993b-d029cf29c8b9

Sentiment,

I can not prove it, but I strongly believe that the Germans used a closed system for the manufacture of DCvax-L.

I learned that years ago (2012-2013) researchers from the Ghent University Hospital developed a new generation of DC vaccines and they used a completely closed system.
The Ghent University Hospital is located 25 miles from Brussels, the capital of Belgium and of Europe.

Note: Belgium is a neighbor of Germany and Ghent is 130 miles from Cologne (Germany).

Note:The production of the vaccine looks very similar to the production of Dcvax-L.
Some quotes from the Ghent Clinical Immunology, therapeutic & diagnostic platform:

“2011 also saw the birth of Ghent Clinical Immunology: a multidisciplinary platform supported by Ghent University Hospital, integrating clinically-oriented research efforts in the field of cellular immunotherapy and advanced immunological diagnostics.”
http://clinicalimmunology.ugent.be/page2/index.html

“the immunogenic power of the DC can be tamed to produce a cellular vaccine.
This concept opens unique opportunities for the treatment of cancer. Laboratories around the world have come to the same conclusion: cancerous growth can indeed be restrained by properly activated immune cells. Countless experiments have even demonstrated complete and selective eradication of cancer cells by the immune system.
With this knowledge, the idea was born to generate large amounts of dendritic cells from the blood of cancer patients, to activate these cells in vitro and to load them with extracts (“antigens”) from the patients’ tumor. This DC vaccine is then injected back into the patient. The aim is to have the activated DCs teach sufficient amount of killer lymphocytes to go seek and destroy cancer cells.”
“Thanks to support from Ghent University Hospital's “spearhead research initiatives”, the Foundation against Cancer, the Flemish League against Cancer and the IWT (Flemish agency for Innovation by Science and Technology), we are now developing a new generation of DC vaccines”.
http://clinicalimmunology.ugent.be/page10/page5/index.html

Below the page you find pictures how DC cancer vaccine prototypes were produced at Ghent University Hospital.

“The cells are run through the CliniMACS device, which uses magnetic fields to extract the monocytes in a completely closed system. The result is a cell bag containing 99% highly viable monocytes.”

About Fraunhofer IZI, first this comment: the building projects of the Fraunhofer IZI are sponsored 60 percent by the European Union and 20 percent each by the Federal Ministry of Education and Research and the Free State of Saxony. In the same manner, the expenses of about 11 million Euros for construction and equipment of the extension building were covered.( Fraunhofer IZI Annual Report 2014 P.167 )https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2014.pdf

I think Fraunhofer is the most valued research center in Europe!

Look at the equipment GMP Cell and Gene Therapy-IZI Fraunhofer. They have a CliniMACS Prodigy® device! (remember at Ghent University Hospital the cells were run through the CliniMACS device in a completely closed system).
https://www.izi.fraunhofer.de/en/departments/leipzig-location/gmp-cell-and-gene-therapy.html#tabpanel-3

Of course, i can not prove the Germans used a CliniMACS device to produce Dcvax-L!

More about CliniMACS Prodigy®:

The CliniMACS Prodigy® is a closed and automated platform with the capability to manufacture various cell types on a single device and within a single process setup. It delivers consistent product quality in every batch enabling reproducible cell production.
The closed system eliminates open processing steps and unnecessary operator transfers between multiple devices. Thereby, the contamination risk and associated quality variation from human intervention is significantly reduced.
https://www.miltenyibiotec.com/BE-en/products/cell-manufacturing-platform/clinimacs-prodigy.html

For me it seems very unlikely that the Germans used an open system to make the vaccine.
And on the other hand you also have the Hospital Exemption and the strict Regulatory notes!
For those who are interested in HE, you can find a lot of information in this Master Thesis, Dr. Anna Schnitger: The Hospital Exemption, a regulatory option for unauthorised ATMP's.

The Master Thesis is from 2014 but you will also find some information about Dcvax-L and HE.

http://dgra.de/media/pdf/studium/masterthesis/master_schnitger_a.pdf
Best Wishes!

Flipper44,

Perhaps you can find here one more indication of using a closed system in Germany: GMP Cell and Gene Therapy-IZI Fraunhofer- Eguipment- CliniMACS Prodigy®:

"The Department of GMP Cell and Gene Therapy operates Fraunhofer IZI's three modern GMP facilities consisting of ten separate clean room suites (altogether 21 clean room grade B manufacturing rooms) which have been specially optimized for manufacturing of cell and gene therapy products, so called Advanced Therapy Medicinal Products – ATMP. The particular specialty of the about 90 highly qualified staff members is the GMP-compliant manufacturing and quality control of investigational medicinal products. GMP-compliant process and quality control development as well as the creation of Standard Operating Procedures (SOPs) are intensively discussed with the project partner before being implemented. The leading staff in charge has many years of experience in designing GMP-processes in the cell therapy area."

https://www.izi.fraunhofer.de/en/departments/leipzig-location/gmp-cell-and-gene-therapy.html#tabpanel-1

Equipment:

Class A (100), B (100), C (10,000), and D (100,000) pharmaceutical clean rooms with a total area of about 1000 sqm, modular structure, divided into suites with separate air filtration. We offer altogether 21 class B manufacturing rooms within three separate clean room facilities for handling different kinds of manufacturing projects for cell and gene therapy products. If required the rooms can be operated according to gene technology safety level S2.
• Qualified equipment for the production of cell-based medicinal products, e.g. particle-monitored class II laminar flow workbenches, CO2-incubators (some with oxygen regulation), refrigerated centrifuges, inverse microscopes, controlled rate freezers for the cryopreservation of cells, storage tanks for storing cells in the vapor phase of liquid nitrogen, CliniMACS®-cell separation system, CliniMACS Prodigy®, LOVO-Cell Processing System, Sepax S-100-cell separation system, ELUTRA® cell separation system, gentleMACS™ Dissociator for tissue dissociation, TSCD II Sterile Tubing Welder, CR6 Tube sealers, etc.)
• Qualified equipment for the quality control of cell-based medicinal products (e.g. Cytomics™ FC500 MPL, FC500 Navios and MACSQuant® flow cytometer, LightCycler realtime-PCR-Cycler, Tecan Sunrise ELISA-Reader, Vi-CELL™ device for the automatic determination of cell count and viability, Sysmex XS-800i haematology system)
• Qualified equipment for sterility testing (BacT/Alert® 3 D Dual T-microbial detection system, Equinox-pump, overpressure isolator within clean room class C) and testing for bacterial endotoxins (Endosafe®-PTS™)
https://www.izi.fraunhofer.de/en/departments/leipzig-location/gmp-cell-and-gene-therapy.html#tabpanel-3

More about CliniMACS Prodigy®:

The CliniMACS Prodigy® is a closed and automated platform with the capability to manufacture various cell types on a single device and within a single process setup. It delivers consistent product quality in every batch enabling reproducible cell production.
The closed system eliminates open processing steps and unnecessary operator transfers between multiple devices. Thereby, the contamination risk and associated quality variation from human intervention is significantly reduced.
https://www.miltenyibiotec.com/BE-en/products/cell-manufacturing-platform/clinimacs-prodigy.html

Regulatory notes:

CliniMACS® Products
The CliniMACS System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans, the national legislation and regulations - e.g. for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.

https://www.miltenyibiotec.com/BE-en/regulatory-notes.html

TOUCAN chose Kirsten Heukelbach as QA Manager at Advent Bioservices.

Kirsten Heukelbach

QA Manager at Advent Bioservices
United Kingdom
•
Dates Employed Jan 2018 – Present
Employment Duration 5 mos

•
“”Highly organized and experienced Pharmacy Production Manager with an in-depth understanding of pharmaceutical quality challenges and Good Manufacturing Practice (GMP). Manages operations supplying industry-leading services to pharmaceutical companies for Phase I and Phase II clinical trials from trial design through to report. Highly experienced in preparation of a wide variety of dose forms, sterile and non-sterile products, radiopharmaceuticals, repack/randomise/label IMPs, QP releases, controlled drugs and products for parenteral administration. Strong organisational and business acumen gained in working closely with trial sponsors and stakeholders at executive level, and in a multidisciplinary team commanding respect of medical, nursing, technical and administrative staff.
A fluent speaker of English and German and Graduate Pharmacist registered with the Royal Pharmaceutical Society and General Pharmaceutical Council of the UK with Master in Radiopharmaceuticals and PET Radiochemistry near completion.”


Experience:

Head of Pharmacy Production
Company Name Hammersmith Medicines Research Ltd
Dates Employed Aug 2005 – Jan 2018
Employment Duration 12 yrs 6 mos
Location London, United Kingdom

Maintaining and developing pharmacy services to achieve and maintain MHRA-licensed status. Directing, training, supervising and appraising staff. Developing and maintaining immaculate systems for documenting pharmacy procedures, to ensure compliance with Good Manufacturing Practice, managing the maintenance and performance-checking of pharmacy equipment, and ensuring it is serviced and calibrated as required.
Preparing IMPs, including sterile dose forms and radiopharmaceuticals, repackaging and relabelling of clinical trial supplies. Advising company and study sponsors on pharmacy work, and participating in meetings with them as necessary. Advising on and overseeing the purchasing of pharmacy equipment and materials, auditing suppliers and other third parties, as required. Writing and updating pharmacy standard operating procedure.
Advising the Medical Directors on the handling and administration of medicines, to maximise the safety of study subjects and company staff, and to minimise the likelihood of mistakes.
Training nursing and technical staff in pharmaceutical procedures, production issues and GMP principles, as necessary and appropriate.
Advising the Health and Safety Committee, and ward teams, on safe handling of materials.
Assessing safety data and writing COSHH assessments when necessary.
Liaising with pharmaceutical companies, other research laboratories and hospital departments.

Languages:
• English
• German

https://www.linkedin.com/in/kirsten-heukelbach-a2180425/

About Hammersmith Medicines Research Ltd
Pharmaceuticals London:

Specialists in clinical pharmacology phase 1 and early phase 2 trials.
https://www.hmrlondon.com/

Flipper44,

You wrote:

“It just seems the new obligations for reserving rooms with Advent (hello that's Toucan) at the empty arms hotel is just a reason to transfer shares from those with less knowledge, to those with more knowledge”

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140916791

Maybe not so empty rooms!

Pilar Velasco Sevillano

GMP Production Scientist
Advent Bioservices
I.E.S. Benjamín Rua, Madrid
London, Greater London, Verenigd Koninkrijk
270 270 connecties

Hi!

I´ve participated in Spain in several clinical trials like a manager manufacturing to producing mesenchymal stem cells and mononuclear cells under GMP conditions, for implantation in hematology patients and like regenerative treatment in patients with acute myocardial infarction. I worked mainly with cell cultures at unit cell therapy, quality control, microbiological control and staining techniques.

Currently, I have started a fabulous project where I am going to be involved in performing dendritic cell culture as a treatment in oncology patients.


GMP production scientist
Advent Bioservices
sep. 2017 – may 2018: 9 months
London, Reino Unido

Performing dendritic cell culture as a treatment in oncology patients.

https://www.linkedin.com/in/pilar-velasco-sevillano-22026a55/

Best wishes!

Nice- Appraisal-DCVax-L for treating newly diagnosed glioblastoma [ID836]

New project lead: Kate Moore. (Before:Thomas Feist)

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.linkedin.com/in/kate-moore-03310213a/

Doc logic,

I wonder if you are talking here about a phenomenon, which alludes to the fact that immature dendritic cells (Dcvax-D) acquire immunogenic antigens from the tumor through the facilitation of tunneling nanotubes (TNTs) and thus supporting the concept of direct Ag transfer?

Sentiment,

Thank you for sharing that article. Fascinating learning material about Tunneling Nanotubes.

Quote:” The transfer of antigenic information from migratory DCs to lymph node-residing DCs through TNTs was recently shown to be critical for the induction of immune responses”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5474251/

More about tunneling nanotube networks in dendritic cells in the following article:

“CD40L induces functional tunneling nanotube networks exclusively in dendritic cells programmed by mediators of type-1 immunity.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4297732/

Flipper44,
Thanks for the article!

Quote:
“TNTs also play an important role in the immune system. Their function involves dendritic cells, which Robbie Mailliard, an immunologist at the University of Pittsburgh, calls the “quarterbacks of the immune system.” Dendritic cells connect with each other via TNTs in a process called reticulation.”
https://www.quantamagazine.org/cells-talk-and-help-one-another-via-tiny-tube-networks-20180423/

Same terminology used by doctor Charles Cobbs in his presentation.(14 march 2018 min.24)
Quote Charles Cobbs “ Dendritic cells are the quarterbacks”
https://www.facebook.com/SeattleScienceFoundation/videos/1613688522033378/

Thanks Survivor1x.

Article: Predicting analysis times in randomized clinical trials with cancer immunotherapy.

“A new class of immuno-oncology agents has recently been shown to induce long-term survival in a proportion of treated patients. This phenomenon poses unique challenges for the prediction of analysis time in event-driven studies. If the phenomenon of long-term survival is not accounted for properly, the accuracy of the prediction based on the existing methods may be substantially compromised.”


“Given that a subset of the patients is no longer at risk of the event of interest, such as disease recurrence or death, the study duration could be substantially longer than what is anticipated if this phenomenon is not accounted for or is misspecified at the study design stage.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736164/

Thank you IkeEsq! Wish you a nice weekend!

Thanks Beartrap12!

By the way the English version of the annual report 2017 Fraunhofer IZI is available:https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2017.pdf
Page 28.

Have a nice weekend!

Nice Appraisal. This is from 16 August 2017:

“you will be aware, the Department of Health has asked NICE to conduct an appraisal of DCVax-L for treating newly diagnosed glioblastoma Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during mid-June 2018 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-August 2018”

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

I think the appraisal started 10 April 2018-Nice Guidance:

DCVax-L for treating newly diagnosed glioblastoma [ID836]

Draft scope pre referral 10 April 2018
Draft matrix pre referral 10 April 2018

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143/documents

Flipper44,

While the trial was on partial clinical hold in regard to screening of new patients for enrollment Fraunhofer IZI wrote the following in their annual report 2015 for the next year 2016:

“Elaborate manufacturing processes in the clean rooms, quality control and the dispatch of DCVax®-L to be administered to patients will also form the focus of our work in the coming year. During the course of this, involved clinics will be closely supervised and additional clinics will soon be qualified in Germany and the UK.”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2015.pdf

hmm……additional clinics will soon be qualified in Germany an the UK!......in 2016....for a failed vaccine?

Flipper44,

Annual report 2017 Fraunhofer IZI.

N.I.C.E appraisal UK.

Maybe you can add this 2012 quote of Linda Powers to your list.

INTERVIEW WITH LINDA F POWERS (2012)

"JE: So that’s in the United States, an FDA approval process. The European, Germany and London regulators will have to approve by their respective regulators for use in those countries as well?

LP: That’s the objective. But how the system will work – and this is a really important part of our strategy is this; it’s the same trial. We are simply adding the European sites into the same trial that’s already underway in the US, rather than doing a separate parallel set of trials in Europe. That’s really important for several reasons. First of all, it saves us a lot of time on the front end; more than a year but that’s not the key. They key is that by being all the same trial, all the data is going to be pulled together. All the data is going to be presented, when the time comes, in an application for product approval in each location. In the US, we’re going to include both the US and European data, and in Europe we’re going to include both the US and European data, and it makes it a very strong package."

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=77003377

Flipper44,
Your post 167568
____________________________________________________________________
The Germans also manufactured for the Brits back then. See below. Recall there was even European licensing for transport of tissue between countries. I'm not certain the manufacturing for the UK's involvement in the trial was not handled by Germany. King's College may have handled the compassionate program -- or perhaps even part of the UK's involvement in the trial, however, it appears Germany played a significant role.
____________________________________________________________________

The first European patient in the Company's Phase III clinical trial of DCVax-is well known British Shakespearean actor Robert Demeger, who has appeared regularly on the stage and in the popular TV series Doctor Who. This patient was operated on in June, 2013, by Dr. Keyoumars Ashkan, a senior neurosurgeon at Kings College Hospital and the lead investigator for the trial in the U.K., to remove his brain tumor and enable him to enter the DCVax-L trial.
https://www.news-medical.net/news/20131231/BBC-TV-report-profiles-NW-Bios-DCVax-L-Phase-III-trial-for-GBM-brain-cancer.aspx

I suppose he got his first vaccination September 2013.

From the annual report 2015 Fraunhofer IZI : “Furthermore, applications to conduct respective clinical trials were submitted to the responsible authorities in the United Kingdom and Germany and initially authorized in the UK. Consequently, in June 2013, production commenced for the treatment of patients there. Authorization of the trial in Germany the following year then also gave the green light for the production of batches for German patients, which has been ongoing since August 2014.”

I think the production of batches for UK patients came from Germany.

I agree that King's College may have handled the compassionate program.
The following is from King’s College London news and event. Article: Brain Cancer vaccine trial. Posted on 14/05/2012

“Farzin Farzaneh, Professor of Molecular Medicine and head of cGMP cell product manufacturing at King’s College London, said: 'We are excited to be undertaking the manufacture of the vaccine here at King’s. Such immune therapies represent an exciting new class of products, and we are pleased to apply our expertise and facilities for cell therapy to help bring DCVax® immune therapies to the UK and to collaborating centres in Europe.'”
https://www.kcl.ac.uk/newsevents/news/newsrecords/2012/05May/Brain-Cancer-Vaccine.aspx

Note: British actor Robert Demeger passed away in London on 14 September 2014.

Flipper44,

From your post 167582:
_____________________________________________________________________
“Basically, what [Fraunhofer] appears to be saying is that 300 enrollment was statistically sufficient for the trial. Perhaps for everyone. Remember what a big deal NWBO made about 300?”…….” Why Fraunhofer did not discuss the apparent 31 still (at that time) to be enrolled somewhere else is a bit mystifying.”
_____________________________________________________________________

If I understand you correctly then it means that there were no more German patients enrolled in the trial after the beginning of August 2015.
If that is true,the last German patient had his surgery at the end of April or early May 2015. This means that from that moment no more German patients were recruited for the trial That looks like a self-imposed hold on screening. ( Hey,i read the same words in this K10 page 5 https://www.sec.gov/Archives/edgar/data/1072379/000114420417020754/v464066_10k.htm)
Note: when i read post 167616 LesslsMore it seems that most longs here (I still wonder who he means!) believe that the primary (PFS) endpoint failed. We know for sure there was no IA end April, beginning May 2015. ( see presentation Linda Powers May 2015)

Last note about Cognate Management Buyout.

From the PR.:” BALTIMORE, MD and MEMPHIS, TN – Cognate BioServices, a leading contract development and manufacturing organization (“CDMO”) in the global cellular therapies industry, announced today it has completed a management buyout (“MBO”) and raised capital from a group of global investment firms including Santa Monica, Calif.-based Tennenbaum Capital Partners, LLC (“TCP”), Medivate Partners and affiliates (“Medivate”) based in Seoul, South Korea and a sovereign wealth fund……….”“Our investment was driven by a combination of the tremendous opportunity in personalized cell therapy manufacturing and our confidence in the strong management team at Cognate,” said Medivate’s Managing Partner Roger Kang. “We are very excited to be a part of this syndicate and look forward to being part of their continued growth.” https://www.cognatebioservices.com/cognate-completes-management-buyout-raises-growth-capital-fund-commercial-cellular-therapy-manufacturing-expansion/

South-Korea???????

From the annual report 2013 Fraunhofer IZI
Interview with the director Prof. Frank Emmrich (P.8)

“What other achievements relevant to the institute would you like to highlight here? At the start of 2013, we were able to celebrate the opening of a joint laboratory (JLCI – Joint Laboratory of CNUHH in collaboration with Fraunhofer IZI) together with the Chonnam National University in Gwangju, South Korea, on the campus of Hwasun University Hospital near Gwangju. This strengthened our collaborative work and, above all, staff exchange between the two partners. Our next task is to acquire the South Korean pharma and biotech industry as a new customer.”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2013.pdf

South -Korea??????

Maybe COINCIDENTALY or maybe they heard about something “very interesting”?

Doc Logic,

Thank you! First of all, I apologize i forgot the link in my post: https://www.izi.fraunhofer.de/content/dam/izi/de/documents/Publikationen/Fraunhofer_IZI_Jahresbericht_2017.pdf

You say:” What should be noted here is that the number of patients statistically necessary to prove statistical significance drops in proportion to treatment effectiveness. So when saying "statistically necessary" they are talking about the number of patients needed to prove effect not necessarily the total number of patients originally planned for enrollment to prove what might have been a lesser planned for effect.”

100% agree,after i read the article again.(“ Die Rekrutierung der für die Studie statistisch notwendigen Patientenzahl wurde bereits im Jahr 2015 abgeschlossen und damit die Herstellungs- und Prüftätigkeiten an Fraunhofer IZI erfolgreich beendet”)

It’s also important to note that manufacturing and testing activities were successfully completed!

And at the end of the article they say this: “Dieser Prozess wird sich auch im Jahr 2018 bis zum Versand der letzten vorgesehenen Dosierung fortsetzen. Danach ist die Auswertung der klinischen Studie durch den Sponsor Northwest Biotherapeutics Inc. zu erwarten.” (Google translation:” This process will continue in 2018 until the last scheduled dosage is shipped. Thereafter, evaluation of the clinical trial by sponsor Northwest Biotherapeutics Inc. is expected.")

I think that means there was no data lock in 2017 but it can happen any time in 2018.(If i’m right about the protocol:no more Dcvax-L for the patiënt after data lock.)
Do logic in post 167444 you write: “The wild cards appear to October 2017 meeting in Canada……” https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140050303

I think you mean 16-17 October 2017 DCVAX-Monitor meeting!
https://neuromedia.mcgill.ca/mnibooking/report.php

Name: Lisa Nezvitsky
Department Head: Dr. Genge
Meeting Name: CRU Monitor

This one is a guess but i have good reason to believe there was a lot of activity end of Jan.2018 - beginning of Feb.2018 in Canada about the same data!( with Lisa Nezvitsky the person in charge of the DCVAX-L trial in Canada)

Have a nice weekend!

Dan88,

I think you have given an accurate translation of the German text.

I find this interesting:

"The recruitment of the number of patients statistically necessary for the study was completed in 2015, thus successfully completing the manufacturing and testing activities at Fraunhofer IZI."

I thought the number of patients for the German trial was 87 and according to the report, completed in 2015.

Also interesting:"the inspection control was successful".

PS FOTO cleanroom class A

Annual report 2017 from Fraunhofer Institute for Cell Therapy and Immunology IZI (P.28)
Sorry found no English version.

PROJEKTBEISPIELE
Herstellung des Immuntherapeutikums DCVax®-L für Gehirntumorpatienten
Das Fraunhofer IZI war in den vergangenen Jahren der Hersteller eines klinischen Prüfpräparates für Prüfzentren in Deutschland und Großbritannien, dessen Wirksamkeit im Rahmen einer klinischen Studie der Phase III nach wie vor überprüft wird.
Das Immuntherapeutikum DCVax®-L wurde zuvor vom amerikanischen Biotechnologieunternehmen Northwest Biotherapeutics Inc. in den USA bereits erfolgreich in kleineren klinischen Studien eingesetzt. Dieses Arzneimittel für neuartige Therapien (ATMP) basiert auf autologen dendritischen Zellen zur Behandlung von Glioblastomen, einer besonders aggressiven Form von Hirntumoren.

Um DCVax®-L für jeden Patienten individuell herzustellen, wurde den Patienten sowohl Tumorgewebe als auch ein Blutprodukt entnommen und daraus anschließend in einem aufwendigen mehrstufigen Herstellungsprozess das zellbasierte Therapeutikum hergestellt. Die Rekrutierung der für die Studie statistisch notwendigen Patientenzahl wurde bereits im Jahr 2015 abgeschlossen und damit die Herstellungs- und Prüftätigkeiten an Fraunhofer IZI erfolgreich beendet.

Da das Therapeutikum jedoch über einer Zeitraum von 3 Jahren in mehreren Dosen bei den an der Studie teilnehmenden Patienten appliziert wird, wurden im Jahr 2017 noch kryokonservierte klinische Prüfmuster an die teilnehmenden klinischen Prüfzentren zur Applikation am Patienten verschickt.
Dieser Prozess wird sich auch im Jahr 2018 bis zum Versand der letzten vorgesehenen Dosierung fortsetzen. Danach ist die Auswertung der klinischen Studie durch den Sponsor Northwest Biotherapeutics Inc. zu erwarten.

Flipper44,

I think i found more evidence of the use of an optimized DCVAX-L in Germany in the annual reports from Fraunhofer Institute for Cell Therapy and Immunology IZI 2013 and 2015. I also think the HE in Germany requires a more stringent process.

From the annual report 2013.
Interview with the director Prof. Frank Emmrich (P.8)

“As early as spring 2013, we were able to lay the foundation stone for the next structure, the second extension building. Once again, through the fantastic support provided by the
City of Leipzig, the Fraunhofer IZI received a leasehold for a plot of land which has allowed us to build an additional laboratory on Perlickstraße between the main building and the BioCube. This will be almost the same size as the main building and will also be connected to the main building through a number of passages. Besides modern laboratories for GLP and GMP work and a special S3 laboratory for vaccine development, this building is especially distinguished by its ”marriage stations” for joining biomedicine with biotechnology.

Here, the focus will predominantly be on developing automated cell technology devices, which will support the development of new diagnostic and therapeutic procedures. Both the first and ground floors will feature glass showrooms where respective development processes and the application of cell technical device combinations can be observed. This will make the institute more transparent and attractive for visitors, international partners, customers and also advanced training events”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2013.pdf

In conversation with Dr. Gerno Schmiedeknecht (P.22)

“What particular challenges did the 2013 reporting year have in store for the department of Cell Engineering and what is the outlook for 2014? The greatest challenge of 2013 came with the commissioning and GMP-compliant qualification of the new clean room facility in the Fraunhofer IZI’s first extension building. Carrying out this work required numerous external service providers to be coordinated, a range of risk analyses to be drafted and checked, validation plans and reports to be written, and the existing quality assurance system to be expanded to include the newly added rooms, equipment and procedures. All of this had to take place during business hours, which meant at the same time as production and quality controls for active clinical trials, which were being conducted on behalf of our customers. As we were unable to bring in additional members of staff for this work, my colleagues found themselves facing an enormous workload. I would like to take this opportunity to thank them once again for all their efforts. Besides this, following complex preparatory work and authorization procedures, a real highlight of 2013 was when we started to manufacture and conduct quality controls for investigational medicinal products with regard to two of our key projects: CVac™ on behalf of Prima BioMed Ltd. and DCVax®-L for Northwest Biotherapeutics Inc. / Cognate BioServices Inc. The next challenge is already in sight for 2014 in the construction and qualification of an additional celltherapy clean room facility in the Fraunhofer IZI’s second extension building”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2013.pdf

From annual report 2015:
T. (P.27)
…….” With the second extension building, the department now has access to several special laboratories and devices. For example, a safety level 3 laboratory for experiments involving infectious materials, a core facility for implementing the latest nano-biotechnology methods and a facility for the GMPcompliant production of antibodies were completed and prepared for operation. These expanded instrument-based and lab technology facilities have already provided the basis for several newly acquired projects in the department.”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2015.pdf

DR. GERNO SCHMIEDEKNECHT (P.31)

“Highlights and challenges in the 2015 reporting year Thanks to a newly established major project carried out together with an international pharmaceuticals company, the Cell Engineering / GMP Unit increased its capacities to 90 members of staff over a short space of time and significantly rearranged its structure. Quickly integrating so many new members of staff in the existing team and providing them with effective training on the regulations governing our complex quality assurance system and the complicated manufacturing and quality control procedures by far posed the greatest challenge of last year.”
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2015.pdf

And the following is from the same annual report 2015 and posted by Flipper44 a few days ago(P.35)

“Manufacture of the immunotherapeutic product DCVax®-L for brain tumor patients
Fraunhofer IZI is producing and optimizing an investigational medicinal product in Europe, the efficacy of which is currently being investigated as part of a phase III clinical trial. American biotechnology company Northwest Biotherapeutics Inc. has already successfully used the immunotherapeutic product DCVax®-L in clinical trials in the US. This advanced therapy medicinal product (ATMP) is based on autologous dendritic cells for the treatment of glioblastomas, a particularly aggressive type of brain tumor.
To be able to manufacture DCVax®-L for each individual patient, tumor tissue and a blood product have to be taken from the respective patient. Numerous clinics taking part in the study have undergone an elaborate qualification and auditing process in order to obtain the required authorization for the procurement of tissues in accordance with Section 20b (2) of the German Drug Act (AMG).
Besides monitoring quality standards at the clinics, manufacturing company Cognate BioServices Inc. also established the manufacturing process and related analytic methods in 2011/2012 at Fraunhofer IZI. Following successful validation, manufacturing authorization was granted specifically for DCVax®-L by the Landesdirektion Sachsen (Saxony Land authorities) and the Paul-Ehrlich-Institut (responsible federal pharmaceutical supervisory authority) in accordance with Section 13 AMG.
Furthermore, applications to conduct respective clinical trials were submitted to the responsible authorities in the United Kingdom and Germany and initially authorized in the UK. Consequently, in June 2013, production commenced for the treatment of patients there. Authorization of the trial in
Germany the following year then also gave the green light for the production of batches for German patients, which has been ongoing since August 2014.
Alongside the clinical trial, a special provision pursuant to Section 4b AMG was also granted by the Paul-Ehrlich-Institut (manufacture since October 2014). Treatment pursuant to Section 4b AMG is permitted using advanced therapy medicinal products provided such products are individually prepared for patients who are unable to be enrolled in clinical trials due to strict exclusion criteria.
The capacity increases surrounding the new clean rooms and staff, which have been ongoing since 2013, and the regular updates to the submission documents continued to pose a major challenge to the entire group.
Elaborate manufacturing processes in the clean rooms, quality control and the dispatch of DCVax®-L to be administered to patients will also form the focus of our work in the coming year. During the course of this, involved clinics will be closely supervised and additional clinics will soon be qualified in Germany and the UK.”

Best Wishes.

Flipper,

From: The expanding role of the clinical haematologist in the new world of advanced therapy medicinal products
Mark W. Lowdell
Amy Thomas

“Taking the UK as an example, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency with the statutory right to determine whether the product is an ATMP or a cell therapy, which would then be regulated under the EU Tissues and Cells Directives (EUTCDs). This is not a trivial decision, as even minimally manipulated therapies might be classified as an ATMP if the cells will be used ‘non-homologously’, i.e. not intended to be used for the same essential function(s) in the recipient and the donor – even when the cells are used autologously.”……..

“The EUTCD is the legislation with which all HSCT haematologists are familiar as it is the basis of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). Under these Regulations, the Human Tissue Authority (HTA) licenses and inspects establishments that undertake the procurement, testing, processing, storage and distribution of human cells and tissue for therapeutic use and this authority extends to licensing procurement of human cells and tissue for manufacture of an ATMP. This piece of legislation, requiring licensing of procurement of human cells and tissues, is unique to the EU. The US Federal Drug Administration regulates the manufacture and supply of cell-based medicines and the Australian Therapeutic Goods Administration regulates ATMP equivalents as ‘biological medicines’ but neither yet requires licensing of the clinical site where the patient or donor cells/tissues are procured.”
https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.14384

Neuro-Oncology, Volume 18, Issue suppl_6, 1 November 2016, Pages vi19

ATIM-09. SUCCESSFUL EXPERIENCE WITH CLINICAL TRIALS FOR HIGH GRADE GLIOMA IN A COMMUNITY SETTING.
Lars Anker Lavinia Dobrea Joy Nakhla Viorela Pop Lawrence Wagman

"Nationally, 20% of adults with cancer qualify for a clinical trial, yet only 3–5% consent. Over the last 4 years, we evaluated 58 patients for 8 different high grade glioma treatment trials, with 50% consenting (29/58). Of 19 patients who received at least one dose of study agent, 79% (15/19) completed treatment. Nationally, 30% of patients drop out of a clinical trial, whereas our voluntary withdrawal rate was only 3%. We had a 100% success rate in harvesting specimens for an autologous vaccine trial (DCVax®-L)."
https://academic.oup.com/neuro-oncology/article/18/suppl_6/vi19/2541936

From Dr.Cobbs presentation (Individualized Treatments for Glioblastoma)
on March 14, 2018. (Cranial Conference)
https://www.facebook.com/SeattleScienceFoundation

Dr.Cobbs report on a patient (still alive after 15 years) with glioblastoma who developed an extremely robust human cytomegalovirus (HCMV)-specific CD8+ T-cell response to the pp65 CMV immunodominant epitope that began immediately after one injection of autologous tumor lysate-pulsed DC.(DCVAX-L min. 25)

I think he is talking about this case study:
“Induction of Cytomegalovirus-specific Anti-tumor Immunity after Autologous Tumor Lysate-pulsed Dendritic Cell Vaccination in a Patient with Glioblastoma”
Robert M. Prins, Ph.D., Timothy F. Cloughesy, M.D., and Linda M. Liau, M.D., Ph.D.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2775501/

Flipper,

Dr.Cobbs presentation (Individualized Treatments for Glioblastoma) was
on March 14, 2018. (Cranial Conference)
https://www.facebook.com/SeattleScienceFoundation

Video published on March 29.

quote:

"Bizarre. The article makes no mention of DCVax-L, which appears to be the reason she is tumor-free now."

Maybe because one of 8 world leading "Trustedoctors" for brain tumour is neurooncologist Roger Stupp?

https://trustedoctor.com/search/doctors?disease=0&treatment=1&area=Worldwide

“The women who defied the odds to overcome a brain tumour”

October 17, 2017 By: Trustedoctor

"Kathleen Charles was diagnosed with a brain tumour at 29, today she is a living example of the impressive power of the human spirit."

https://blog.trustedoctor.com/2017/10/17/the-woman-who-defied-the-odds-to-overcome-a-brain-tumour/

Kathleen Charles from KatsCure!

https://www.facebook.com/katscure/

Doc logic,

Thank you!
Indeed,the microhole chip offers a high potential for the micromanipulation and sorting of cells.( 100% sensitivity, 100% specificity?)
You can read more about the science in this paper “Raman-Spectroscopy Based Cell Identification on a Microhole Array Chip”.
http://www.mdpi.com/2072-666X/5/2/204/htm

One of the authors is Dr. Thomas Velten, whose team at the Fraunhofer Institute for Biomedical Engineering IBMT developed the new microhole chip.

From WIPO:
DE102011117228 Mikroskopiesystem zur Zustandsbestimmung von Zellen

https://patentscope.wipo.int/search/en/detail.jsf?docId=DE105031874&recNum=2&maxRec=9&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=FP%3A%28Dr.+Thomas+Velten%29&tab=NationalBiblio

From Google Patents:
“Miniaturised microscopy system for determining the state of cells “
Inventor :Thomas Velten

WO2013060478A1
https://patents.google.com/patent/WO2013060478A1/en

About Fraunhofer and Microelectronics:
"We offer:
-material diagnostics of components, assemblies and materials of electronics, microsystems engineering and nanotechnology
-complex physical failure analysis, numerical simulation and life prediction
-development of diagnostics, test, and modelling methods and the corresponding tools"
https://www.imws.fraunhofer.de/en/kompetenzfelder/mikroelektronik.html

Flipper,

Thank you to draw attention to the patent. It was very helpful!
Best wishes!

https://patentscope.wipo.int/search/docservicepdf_pct/id00000036225689/PAMPH/WO2017004230.pdf?psAuth=N_8EowYrLmaGoVWELZLcQHSimoPgDx5-GTgoBgLi18w

Doc,

Thanks for pointing that out! I think the microhole chip is a very powerful device for cell isolation handling and cell analysis.

Doc, do you have you any evidence (scientific paper, patent, something else?) that the Fraunhofer Institute for Biomedical Engineering IBMT integrated the microhole chip into the TFF (tangetial flow filtration) system?
Best wishes!

Doc,

Is the new cell selection chip technologie (Fraunhofer) developed for this?:

“The specific genetic reprogramming DC undergo upon activation can be easily investigated by using microarrays to perform global gene expression analysis in different conditions.”

Gene Expression Profiling of Dendritic Cells by Microarray https://link.springer.com/protocol/10.1007/978-1-59745-395-0_13

Flipper,

Quote:
“Remember Dr. Bosch saying (for Direct that is) Method A was only partially potent whereas method B was more potent? I think you might hear the same exact comment from NWBO/UCLA with regard to before Germany, and after Germany. The publication likely to be critical, and now it dawns on me, because I only vaguely understand patent approvals, that Doc may be right there might have been more optimization than just TFF. Doc thinks it has something to do with cell selection chip technology developed by Fraunhofer. Anyway, if this whole hypothesis is correct, the publication would, imho, be very important for the patent office. JMHO. – flip”

Are you talking about the new microhole chip, developed by the Fraunhofer researchers (Fraunhofer Institute for Biomedical Engineering IBMT)?
And if so, do you have any idea how this new cell selection chip technology can be applied in the development of a more potent dcvax?

More about the new microhole chip: https://www.fraunhofer.de/en/press/research-news/2017/june/single-cells-lined-up-like-ducks-in-a-row.html

Don’t worry about "Meifud" and its figures. He's not as good at mathematics.This is what he wrote 6 days ago on Yahoo message:

Quote Meifud:
Meifud 6 days ago

“after full enrollment in 2015, even Linda Liau was described as having these concerns with the phase III...
-- "She sounded a cautionary note that the proscribed endpoints for the trial which are median progression free survival or mPFS (primary endpoint) and median overall survival or mOS (secondary endpoint) may not be the right endpoints for the trial...She worries that this could be an issue for the trial."
-- "She also notes that patients who were started on placebo and whose disease progressed were allowed to switch to DCVax-L. This confounds the overall survival analysis as 67% of patients initially received DCVax-L; 19% of control patients received DCVax-L at a later time after their disease progressed; and 14% did not receive DCVax-L. This could confound the analysis of overall survival."


“19% of control patients received DCVax-L at a later time after their disease progressed”???

WE ALL KNOW BETTER!

I think i’m wrong about the planning. At this moment you see “March 2018” in the announcement. Most likely if you visit the website next month it changes to April 2018 and so on….Sorry for that but the Pub Date was 8 months ago.
http://uk-jobs.pro/offers/2946d256fccfcebc/quality-assurance-manager-jobs-advent-bioservices-sawston-august-2017

Flipper,
Thanks to answer my question! It was very helpful and helped me to better understand the current situation.

I want to add two small things:
First about Mr. Woodford and the Phase V Report.

I learned from the Employment Appeal Tribunal paper that a text was sent by Mr. Woodford to Mr. Malik on 29 October 2015 and it shows that Mr. Woodford did not think much of the Phase V.
https://www.employmentcasesupdate.co.uk/site.aspx?i=ed36861
(on the bottom of the paper)

So, it’s my opinion that on 29 October 2015 the Phase V Report was, for Mr.Woodford, nothing to worry about.

Secondly, about Advent Bioservices and new job(s).

The Company is searching at this moment for a GMP Production Scientist. https://www.indeed.co.uk/jobs?q=ADVENT%20BIOSERVICES&l&vjk=cc093a397983ab93

But 8 months ago, August 2017, Advent Bioservices was looking for a Quality Assurance Manager Job Openings by Advent Bioservices in March 2018.
http://uk-jobs.pro/offers/2946d256fccfcebc/quality-assurance-manager-jobs-advent-bioservices-sawston-august-2017

“To help make this business eye-sight and mission happens accurate; Advent Bioservices is usually open pertaining to fresh placement as begin from March 2018. Everybody who is enthusiastic about filling up this specific vacant, please participate in this Quality Assurance Manager Jobs recruitment inside . It is suggested for many contributors to arrange just about all essential demands due to this job recruitment treatment, for the reason that method need you to definitely allow acceptable spec that this business desires because of this place. If you are that you will be one that can certainly fill up the actual specs, you can try to see more information about Quality Assurance Manager Jobs below.
Advent Bioservices Job Opportunities 2018
Quality Assurance Manager Jobs – UK

An exciting opportunity has arisen to join an emerging contract bioservices organization providing GMP manufacturing services and process development for novel cell and gene therapy products. This is an exciting role for a high caliber QA Manager with a strong background in GMP manufacturing of medicinal products. The QA Manager will report to the Director of Quality. This role will provide appropriate quality operational management and will have input in the development, operation and maintenance of quality systems.
Job Description
The QA Manager will take responsibility for validation, operation and management of the Quality Management System (QMS). They will have a pivotal role in the successful application and inspection process for a Manufacturing Authorisation and a Specials Manufacturing Authorisation from the MHRA at a newly built facility. The QA Manager will be integral in developing and embedding a culture of quality in the Advent Bioservices’ growing business. They will support compliance with principles and guidelines of GMP for the production of Advanced Therapy Medicinal Products (ATMPs).
Responsibilities
• Management of the controlled document system including standard operating procedures, batch manufacturing records, labelling, executing validation plans, change control, non-conformance and issuing and reviewing CAPAs
• Responsible for GMP procedures and systems and ensuring compliance
• Responsible for planning, implementation and control of the QMS, the validation master plan and for coordinating and delivering training to ensure compliance
• Responsible for the quality aspect of technology transfer projects with regards to validation and change control documentation
• Participate in the inspection process by the MHRA and HTA for manufacturing and storage licensing
• Implement and maintain a compliance auditing programme to fulfill
• Support the continuing development of GMP operations to ensure the facility is kept current with respect to changing regulatory and industry expectations
Essential or Desirable Qualifications and Experience
• BSc or MSc in a life sciences subject, or comparable experience (essential)
• A minimum of 2 years’ experience in a QA management position (essential)
• Experience within a GMP Quality Department and experience working in a sterile manufacturing facility (essential)
• Experience in implementation and operation of an electronic QMS (essential)
• Experience of validation of equipment and facility
• Strong management, organizational and training skills
• A sound scientific understanding of cell and gene therapies and tissue engineered products (highly desirable)
Job Type: Permanent
Salary: £45,000.00 to £55,000.00 /year
Required education:
• Bachelor's
Required experience:
• Quality Assurance management: 2 years
As one of the leading company in UK, Advent Bioservices offers variety of opportunities for employees to grow and make them as future leaders of the professional and disciplined. Advent Bioservices also offers a dynamic work environment in order to encourage employees to contribute optimally, and at the same time is able to escalate new skills and erudition through the company programs.
If Ms interested to registrate Quality Assurance Manager Jobs UK March 2018 Advent Bioservices Advent Bioservices, immediately prepare requirements / files and documents needed for submit Quality Assurance Manager Jobs UK March 2018 Advent Bioservices above. To apply by online, please click the "Apply" button below. If you still do not satisfy with our job recruitment information above, you can try to read other job recruitment information that we provide in our website which still located in UK region from any other company. “

So, maybe to expect more jobs and more than eight months ago planned

Flipper,
You say:
______________________________________________________________________________
Quote:
"Four important things happened over the last couple weeks.

1. Cognate management completed buyout of its own company from Toucan. An international "syndicate" helped resource Cognate buyout from Toucan. It was a friendly buyout that was reportedly years in the making.

2. Astra Zeneca received approval for checkpoint inhibitor "Imfinzi" in stage III unresectable lung cancer that does not (and/or no longer) responds to chemotherapy. No foreseeable competition for that indication in the near future. (I'd call that a foot in the door.)

3. NWBO Board member Navid Malik (Neil Woodford friend) was allocated 9,065,000 of options from NWBO Directors. (Woodford fund's largest investment is Astra Zeneca)

4. Advent is transferring (aka: "migrating") its facilities from NW London to Sawston over the next 18 months.

(Note: UK's NICE has not changed it's plan to start DCVax-L appraisal this coming summer ("Begins" Mid June, 2018. NICE UK has announced/designated June 2018 since last August 2017)"
______________________________________________________________________________

I don’t understand point 3 about Mr.Navid Malik. (https://www.nwbio.com/northwest-bio-welcomes-new-additions-to-the-board-of-directors/).

Can you explain why it’s so important for you dat NWBO Board member Navid Malik was allocated 9,065,000 of options from NWBO Directors!( http://ih.advfn.com/p.php?pid=nmona&article=76855792)

We know that Mr. Navid Malik introduced Mr Woodford to Northwest Biotherapeutics.

Source :” Mr Cooper was concerned not only by the Claimant's undisclosed shareholding but also about the possibility that the Claimant had been more involved in the day-to-day dealings of NWB than he had led the Respondent to believe and that the Claimant may have introduced Mr Woodford of WIM to NWB. That could give rise to a conflict of interest.
(e) Mr Phillips interviewed the Claimant on 7 and 21 October 2015 about his involvement with NWB. During the course of those meetings, the Claimant accepted that he was a shareholder of NWB and that he had introduced WIM to NWB. Notwithstanding this, the Claimant was not suspended at that time."

https://www.employmentcasesupdate.co.uk/site.aspx?i=ed36861

On the other hand we know that Cenkos have a strong relationship with Neil Woodford, which has generated a lot of business for them.

From the same source:” Mr Hodges was influenced by the Claimant's relationship with an institutional investor with whom the Respondent worked regularly, Mr Woodford of Woodford Investment Management(WIM)".

https://www.employmentcasesupdate.co.uk/site.aspx?i=ed36861

On October 2015 the Phase V report came to our attention.
On November 4, 2015 Mr.Malik, head of life sciences research at Cenkos Securities, has been suspended with pay while the stock broker investigates the allegation.

Mr. Malik lost his employment case as plaintiff against Cenkos.

https://www.gov.uk/employment-appeal-tribunal-decisions/dr-n-malik-v-cenkos-securities-plc-ukeat-0100-17-rn
https://www.warnergoodman.co.uk/news/employment-law-case-update-malik-v-cenkos-securities-plc

Strange story. On the one hand you have the good relationship between Mr Malik and N. Woodford, and on the other hand, you have the business relation between N.Woodford and Cenkos. Looks like a conflict of interest. Any Thoughts???

Evaluate,

Thank you for the Job posting:

“The GMP Production Scientist will be responsible for performing batch manufacturing of the company’s contract manufacturing products to support the delivery, in the first instance, of Advanced Therapeutic Medicinal Products (ATMPs) as both ”Specials” and as Investigational Medicinal Products (IMPs)"

https://www.indeed.co.uk/viewjob?jk=cc093a397983ab93&tk=1c7o2r9b7386s93t&from=companyalert&alid=59e10165e4b072486e9ee674&utm_source=jobseeker_emails&utm_medium=email&utm_campaign=job_alerts&rgtk=1c7o2r9b7386s93t

An advanced therapy medicinal product (ATMP) is a medicinal product which is either:
• a gene therapy medicinal product
• a somatic cell therapy medicinal product
• a tissue engineered product

see: Guidance Advanced therapy medicinal products: regulation and licensing

https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing

This is from www.clinicaltrialsregister.eu:
DCVAX-L:
D.3.11.3.1 Somatic cell therapy medicinal product Yes

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB

I think maybe this is the scientific
recommendation:http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/08/WC500147207.pdf

Flipper,

From https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

DCVax-L for treating newly diagnosed glioblastoma [ID836]
In development [GID-TA10143] Expected publication date: 24 April 2019

So ,new job is from 6 days ago= end Febr.2018 til end April 2019 = 14 months + 90 days for approval = 17 months!

"Full migration to Sawston from London = 18 months." (Post Flipper)

https://www.indeed.co.uk/viewjob?jk=cc093a397983ab93&tk=1c7o2r9b7386s93t&from=companyalert&alid=59e10165e4b072486e9ee674&utm_source=jobseeker_emails&utm_medium=email&utm_campaign=job_alerts&rgtk=1c7o2r9b7386s93t