NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

2014 Ovarian STUDY:

https://www.prnewswire.com/news-releases/nw-bio-making-a-joint-poster-presentation-on-its-dcvax-direct-trial-at-the-29th-annual-sitc-meeting-281912681.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3583933/?report=reader


MISCELLANEOUS:SkyLimit2022

Re: HyGro post# 518269

Sunday, October 02, 2022 3:42:57 PM

Post#
518504
of 518553

HyGro, I wonder why you don’t go over to the NVCR message board and post cherry-picked SEC disclosures from their February 24th 2022 SEC filing. Their risk disclosures start on page 26 of the NovoCure filing posted below. You stated that SEC filings are submitted under penalty of perjury and should be considered by investors. I tend to believe that the documents as a whole are important, but we could follow your lead and pluck out some interesting risk statements to publish in isolation. What do you think?

https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25

The Danish Dude

Re: None

Sunday, October 02, 2022 5:53:24 AM

Post#
518358
of 518553

I have compiled a "what has happened in 2022" guide or in other terms "Let's pump it" for those who haven't heard of the phenomenons of reason, rationality, logic, that makes it possible to put forth information and thesis that are qualified with regards to being either uncompromising facts, or very probable.

Let's take a stroll down the 2022 memory lane and sum up, why the NWBO stock currently is the best stock investment since Gamestop around new years eve 2020, at this ridicolous price level.

Facts

January 9th.

The use of the external control arms trial design gets thumbs up by FDA, as the article "External Control Arms in Oncology: Current Use and Future Directions", gets printed in Annals of Oncology. 12 co-authors, among these dr. Richard Pazdur, ALL affiliated with U.S. Food and Drug Administration, also known as FDA.

January 11th.
AdventBio announces their new Cryostore and Freezer facility at Sawston.

January 23rd.

It is found out, that dr. Roger Stupp, the man behind The Stupp protocol, which became standard of care for the treatment of glioblastoma (GBM) since its publication in 2005, became an advisor to NWBO BEFORE September 26th. 2020.

January 27th, February 17 and 26th.
3 articles in british newspapers specifying the NWBO and AdventBio connection, with the later dedicated to do NWBO's bidding as a CDMO in terms of manufactoring and production.

When reading, one is not in doubt of the "mother-child" setup and what is AdventBio's main purpose.

"Northwest Biotherapeutics has secured MHRA certification for its cancer vaccine trials in the Sawston Business Park, sparking delight for site developer Advent BioServices. Advent, which is based on the Park, has completed the laboratory facilities to UK regulatory standards on behalf of Northwest Biotherapeutics, which is headquartered in Bethesda, Maryland. NW Bio’s Sawston R&D team is working on a cancer vaccine for glioblastoma multiforme, the most aggressive type of brain cancer."



Article reveals that AdventBio are now 40 employees. Most hired within a year.

February 6th.

A Global Glioblastoma Multiforme Drug Forecast and Market Analysis expect DCvax-L to be one of three pipeline agents to have highest sales in the GBM market till 2030.

February 17th.
Advent Bioservices – NW Bio’s contract manufacturer in the UK – has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use.

The first vaccine production for compassionate use treatment is for a glioblastoma patient.

March 2nd.
Dr. Marnix Bosch speaks at the Brain Tumour North West Retreat, a yearly cancer symposium, which is attended by british gbm clinicians. It seems he gets registered late for a 2 hours session, where he is to speak of “Dendritic Vaccine”.

The news is not in any way published. A participant tries to delete his tweet revealing this and blocking anyone writing about it. In vain.

March 31st. 2022
Linda Liau speaks about “Therapy induced resistance in glioblastoma” at University of Miami. She talks about the UCLA Spore 1 project, which directly mentions the use of DCVax-L in conjunction with PD-1 inhibitors.

She also talks about the combo trial that started in 2010, that has run for 12 years, combo'ed with Resquimod and nt least Poly-ICLC:

"That’s actually another project, we’re working on getting collaboration with Mark Gilbert and NCI. We’re actually trying to collect all these people, because even in our immunotherapy trials, I think we have about 50 of them now, that are over 5 years going on 10 years"

“The group that got dendritic cell vaccination plus poly-ICLC had a 50% survival rate and now the majority of these patients are reaching 100 months and with not only survival but really no tumor recurrence.”



May.
Dr. Linda Liau is in the UK.

May 10th.
Results of the P3 DCvax-L trial is presented at NYAS. All endpoints met, statistic significance. Landmark results, the best seen in 3 decades.

June 5th.
Northwest Biotherapeutics Announces Presentations On DCVax®-L Personalized Vaccines, Manufacturing and Scale-Up, and DCVax®-L Clinical Program. They are now able to scale to 1.000 patients pr. month. 12.000 pr. year.

June 6th.
Professor Keyoumars Ashkan from Kings Hospital in London presents P3 DCvax-L results in a video.

June 8th.
Hugh Adams, Head of Stakeholders Releations from the british Brain Tumour Research organisation writes the following in an email:

"Thank you for your email, your information and your advice. We communicate directly with Linda Powers at NWBio and most recently facilitated her contributing to a meeting with UK politicians as part of an inquiry into the pathway to a cure for brain tumour patients."



May 16th.
NWBO submits annual OTCQB certification Michael Fox (new) and Sarah MacLeod (known) have been added as IR/PR service providers.

About Michael Fox:

With more than 25 years of experience in strategic communications at global PR agencies and in politics, Michael has advised leading global companies, promising start-ups, respected organizations and political candidates across the full range of communications, media and reputation management activities. He leads the Corporate Communications Group at ICR and specializes in corporate positioning, executive coaching, crisis, transactions and special situations.

Michael has provided communications counsel on more than 100 IPOs, scores of M&A transactions.



June 23rd.
Professor Keyoumars Ashkan yet again presents the P3 DCVax-L trial results at BNOS in Liverpool in England. At the presentation is Linda Powers CEO of NWBO. Mike Scott CEO of Advent Bioservices. Dr. Roger Stupp creator of the chemotherapy Standard-of-Care and now advisor to NWBO and Hugh Adams, the Head of Stakehold relations at british Brain Tumour Research organisation

July 1st.
Dr. Linda Liau presented the DCVax-L Phase III trial results in Prague, at The Society of University Neurosurgeons 2022 Annual Meeting.

July 6th.
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility

August 17th.
Northwest Biotherapeutics receives final Approval of Pediatric Investigation Plan (PIP) by MHRA, green lighting the use of OS endpoint and external control arm trial design in the P3 Adult trial.

September 30th.
Advent Bioservices continues to hire and have now more than 60 employees. Their latest job roles includes a GMP Production Scientist in London, with the following job description (excerpt).

"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). The post holder will work closely with GMP Production Scientists, Quality Assurance Scientists and facilitate the efficient delivery of cellular therapy products for clinical use."



Correlate that with NWBO press-release from 21st. December 2021, when they announced MHRA Approval Of License for GMP Manufacturing At Sawston, UK Facility and you can not miss how AdventBio are continually hiring people that fullfill NWBO's future plans.

"The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme."



It's only to congratulate those diamond hands, that wonders what the talk about the management not doing their shareholders bidding is all about, who are patiently awaiting the inevitable and who use the extra time to continue to load up.