Others have played the game of saying that despite the failure of the randomized trial the drug worked

Canaccord Genuity LLC (x2) @CG_Driven
Citadel Securities LLC @citsecurities
G1 Execution Services LLC
GTS Securities LLC (x2)
Instinet LLC (x2)
Lime Trading Corp. (x2) @LimeTrading_
Virtu Americas LLC @VirtuFinancial
BofA Securities, Inc. @BankofAmerica
CIBC World Markets, Inc. @cibc
Merrill Lynch Canada Inc. @MerrillLynch
SG Americas Securities, LLC
TD Securities, Inc. @TDAmeritrade
TD Securities (USA) LLC
Clear Street Markets LLC
IMC Financial Market
UBS Securities, LLC @UBS
Credit Suisse Securities (USA) LLC @CreditSuisse

When SoS articles start coming out, it means NWBO is gonna be quiet for a long time.

What the "experts" fail to mention is that court disagreed with the big ticket item of a permanent price impairment due to spoofing. Only the sales by NWBO based on prices closely tied to the alleged spoofs matter.

Here are 18 (see below) Hoffman, not one, and it just scratches the surface....

1. Immunic, Inc. Announces MHRA Validation of Marketing Authorization Application for Onvapt® (nafamostat mesilate) for the Treatment of Pancreatic Cancer (November 9, 2023)
False. This is no where to be found on their press release page: https://ir.imux.com/news-releases?l=50

2. Pharming Group N.V. Announces MHRA Validation of Marketing Authorization Application for Vimizim® (elosulfase alfa) for the Treatment of MPS VI (October 26, 2023)
False. This is no where to be found on their press release page: https://www.pharming.com/news

3.Horizon Therapeutics plc Announces MHRA Validation of Marketing Authorization Application for Krystexxa® (pegfilgrastim) for the Prevention of Febrile Neutropenia in Patients with Non-Small Cell Lung Cancer Receiving Chemotherapy (September 22, 2023)
This was recently bought out. I didn't look further to confirm/deny.

4.Aeglea Biotherapeutics Announces MHRA Validation of Marketing Authorization Application for Pegzilarginase for Arginase 1 Deficiency (August 15, 2023)
False. This is no where to be found on their press release page: https://ir.spyre.com/press-releases?l=25

5.Albireo Pharma Announces MHRA Validation of Marketing Authorization Application for Bylvay® for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) (July 7, 2023)
False. They were bought out March 2, 2023. They weren't even a company when the purported PR happened: https://www.ipsen.com/press-releases/ipsen-completes-acquisition-of-albireo-expanding-the-scope-of-its-rare-disease-portfolio/

6.BioMarin Pharmaceutical Announces MHRA Validation of Marketing Authorization Application for Palynziq® for the Treatment of Phenylketonuria (PKU) (June 15, 2023)
False. This is no where to be found on their press release page: https://investors.biomarin.com/press-releases?l=25

7.Ipsen Announces MHRA Validation of Marketing Authorization Application for Cabometyx® (cabozantinib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) (May 24, 2023)
False. This is no where to be found on their press release page: https://www.ipsen.com/press-release/

8.Jazz Pharmaceuticals Announces MHRA Validation of Marketing Authorization Application for Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for the Treatment of Idiopathic Hypersomnia (IH) (April 12, 2023)
False. This is no where to be found on their press release page: https://investor.jazzpharma.com/news/press-release-archive?page=2

9.UCB Announces MHRA Validation of Marketing Authorization Application for Bimzelx® (bimekizumab) for the Treatment of Moderate to Severe Plaque Psoriasis (March 8, 2023)
False. This is no where to be found on their press release page: https://www.ucb.com/stories-media/Press-Releases?title=&created=&created_1=&page=7

10.Vifor Pharma Announces MHRA Validation of Marketing Authorization Application for Veltassa® (patiromer) for the Treatment of Hyperkalemia (February 1, 2023)
False. This is no where to be found on their press release page: https://www.viforpharma.es/us/media/press-releases

11.PTC Therapeutics Announces MHRA Validation of Marketing Authorization Application for Upstaza® (eladocagene exuparvovec) for the Treatment of AADC Deficiency (January 4, 2023)
False. This is no where to be found on their press release page: https://ir.ptcbio.com/press-releases?page=4

12.Neurocrine Biosciences Announces MHRA Validation of Marketing Authorization Application for INGREZZA® (valbenazine) Capsules for the Treatment of Tardive Dyskinesia in Adult Patients (December 7, 2022)
False. This is no where to be found on their press release page: https://neurocrine.gcs-web.com/press-releases?bdc10a6d_year%5Bvalue%5D=2022&bdc10a6d_widget_id=bdc10a6d&form_build_id=form-YMJV9ghbIm0rBZagpLrciSSXSwkD2dg09I5WD9mgYR0&form_id=widget_form_base

13.Astellas Pharma Inc. Announces MHRA Validation of Marketing Authorization Application for Xospata® (gilteritinib) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation (November 10, 2022)
False. This is no where to be found on their press release page: https://www.astellas.com/en/news?tab=latest&page=21

14.AstraZeneca PLC Announces MHRA Validation of Marketing Authorization Application for Imfinzi® (durvalumab) for the Treatment of Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) after Concurrent Chemoradiation Therapy (October 17, 2022)
False. This is no where to be found on their press release page: https://www.astrazeneca.com/media-centre/press-releases.html

15.Bristol Myers Squibb Announces MHRA Validation of Marketing Authorization Application for Breyanzi® (lisocabtagene maraleucel) for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma (September 20, 2022)
False. This is no where to be found on their press release page: https://www.bms.com/media/press-releases.html

16.Gilead Sciences Announces MHRA Validation of Marketing Authorization Application for Trodelvy® (sacituzumab govitecan-hziy) for the Treatment of Metastatic Triple-Negative Breast Cancer (TNBC) (August 16, 2022)
False. This is no where to be found on their press release page: https://www.gilead.com/news-and-press/press-room/press-releases

17.Pfizer Inc. Announces MHRA Validation of Marketing Authorization Application for Lorbrena® (lorlatinib) f2022or the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (July 5, 2022)
False. This is no where to be found on their press release page: https://www.pfizer.com/newsroom/press-releases?viewsreference[data][argument]=22611&viewsreference[enabled_settings][pager]=pager&viewsreference[enabled_settings][argument]=argument&viewsreference[enabled_settings][limit]=limit&viewsreference[parent_entity_type]=block_content&viewsreference[parent_entity_id]=27021&viewsreference[parent_field_name]=field_view&items_per_page=24&page=5

18.Merck & Co., Inc. Announces MHRA Validation of Marketing Authorization Application for Keytruda® (pembrolizumab) for the Treatment of Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors (June 13, )
False. This is no where to be found on their press release page: https://www.merck.com/media/news/

does the MHRA allow companies to press release the validation of a marketing application of a new drug?

No, the Medicines and Healthcare products Regulatory Agency (MHRA) does not generally allow companies to press release the validation of a marketing application (MA) for a new drug.

Validation is a preliminary step in the MA process, where the MHRA confirms that the application is complete and ready for scientific assessment. It does not imply any opinion on the approvability of the drug.

The MHRA encourages companies to wait until the full assessment is complete and a Marketing Authorisation (MA) decision has been made before issuing any public statements about a new drug. This helps to ensure that accurate and complete information is available to the public and investors.

Here are some key points to remember:

Validation is not a guarantee of approval: Validating an MA simply means that it is formally accepted for assessment. The drug still needs to go through a rigorous scientific review before it can be approved for marketing.
Early press releases can be misleading: If a company releases a press release about the validation of an MA before the full assessment is complete, it could give the impression that the drug is closer to approval than it actually is. This could be misleading to the public and potentially harmful, as it could raise false hopes for patients.
MHRA has clear guidelines: The MHRA has clear guidelines on when and how companies can communicate about new drugs. Companies should always follow these guidelines to ensure that they are providing accurate and responsible information to the public.

Here are some resources that you may find helpful:

MHRA guidance on communicating about new drugs: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
MHRA press releases: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
I hope this information is helpful! Let me know if you have any other questions.

can you cite to the authority for the proposition that "No, the Medicines and Healthcare products Regulatory Agency (MHRA) does not generally allow companies to press release the validation of a marketing application (MA) for a new drug."

While there isn't a single, explicit regulatory directive that directly prohibits press releases about validation of a Marketing Application (MA) in the UK, the position I conveyed reflects a combination of:

1. MHRA Policy on Communication:

Guideline on communicating about new drugs: This document emphasizes responsible communication with patients and the public, stressing the importance of factual and balanced information. While not explicitly mentioning validation, it sets a general tone of caution concerning premature announcements that could misrepresent the development stage of a drug.
Press releases: MHRA press releases typically announce approved drugs or significant milestones like scientific advice received during development, indicating an emphasis on confirmed advancements rather than initial application stages.
2. Interpretation of Validation:

Validation vs. Assessment: MHRA clearly distinguishes between validation (confirming completeness) and assessment (evaluating scientific merit). Public announcements around validation could inadvertently misinterpret this preliminary step as a signal of imminent approval, potentially misleading stakeholders.
Focus on Public and Investor Protection: MHRA prioritizes safeguarding public trust and preventing potentially detrimental speculation. Early pronouncements about unassessed drugs could fuel unrealistic expectations and undermine the importance of a rigorous evaluation process.
3. Regulatory Precedent:

EU Marketing Authorisation Procedure: Though separate from the UK now, the previous centralized authorization process under the EU Medicines Agency (EMA) discouraged press releases on validation, encouraging communication only after positive scientific opinions were issued. This practice serves as a reference point for UK regulations.
4. Industry Best Practices:

PhRMA Code on Interactions with Healthcare Professionals: This ethical code, adopted by many pharmaceutical companies, discourages promotional activities until a marketing authorization is granted. While not directly addressing press releases, it underscores the industry's commitment to responsible communication based on established regulatory steps.
While not a single, definitive rule, the MHRA's overall approach to communication, coupled with regulatory interpretations and industry norms, discourages press releases about validation. Companies wishing to communicate about their drug development pipelines should consider MHRA's guidance and focus on factual updates aligned with established milestones in the regulatory process.

I hope this explanation provides a more nuanced understanding of the underlying factors behind the statement about MHRA and press releases for MA validation.

The problem is that DI has said they plan to announce submission and acceptance. If we get past next week with NO PR, the naysayers here will assume something is wrong. I think 30 days is reasonable to expect to hear of acceptance, especially with the Holidays happening post-submission. third or fourth week of January would make sense. Anything sooner would be a pleasant surprise.

You’ve been predicting acceptance in limited number of days, now you are running scared.

I have never said spoofing doesn’t exist.

You can’t because they don’t exist. Much like naked shorts and spoofing.

I’m just a realist.

In recent years, “spoofing” in the securities and commodities markets has been the subject of numerous federal criminal prosecutions and enforcement actions by the SEC and the Commodity Futures Trading Commission (“CTFC”). See, e.g., United States v. Pacilio, 85 F.4th 450 (7th Cir. 2023) (affirming fraud convictions for spoofing); Coscia, 866 F.3d at 803 (same); United States v. Trunz, No. 19 Cr. 375 (WFK), 2023 WL 4238517 (E.D.N.Y. June 28, 2023) (guilty plea to spoofing); UnitedStates v. Flotron, No. 3:17-cr-00220 (JAM), 2018 WL 1401986, (D. Conn. Mar. 20, 2018) (upholding spoofing indictment); SEC v. Lek Secs. Corp., 276 F. Supp. 3d 49, 60, 62 (S.D.N.Y. 2017) (upholding SEC complaint charging spoofing as violation of Sections 10(b) and 9(a)(2)); CFTC v. Oystacher, 203 F. Supp. 3d 934 (N.D. Ill. 2016) (upholding CFTC’s claim under anti-spoofing statute enacted in 2012).

Yup - best hope is for a quick settlement. I'll take $100-200M and call it a day. Hopefully stave off a considerable amount of dilution until revenue starts coming in. Have no desire to see this go through a trial.

He had that for a weeks...

I challenged a couple to a bet that if submission wasn’t complete by years end, they’d delete their account and if they did, I’d delete mine.

no submission in 2023. So, who wants to make a bet on those facts?

Admit you have both names from both accounts and I will quit posting immediately. No questions asked.

I challenged a couple to a bet that if submission wasn’t complete by years end, they’d delete their account and if they did, I’d delete mine.

no submission in 2023. So, who wants to make a bet on those facts?

That’s in stark contrast to NVCR management.

Note: November PR defines “several” weeks by October PR terms.

Although Hoffy predicted more than one submission in the summer!

Plans for 2023

Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year. The first milestone in the New Year is anticipated to be obtaining the commercial manufacturing license, which is one of the pre-requisites for submission of an application for product approval. In parallel, the top priority and intensive focus will be continued preparation of an application package for product approval, as well as the supporting documentation. The Company already made substantial progress on the application package during 2022, and the Company plans to submit an application as soon as possible after the pre-requisites and preparations are completed.

Grasping? I'm just talking about normal stuff that normal shareholders talk about like governance, options rewards, insider purchases and sales....You know the things that really matter. I don't know why you all always get so angry.

The bet (made in fall 2022) was on APPROVAL of an MAA in 2023. You know that, but upon realizing that had not chance in hell changed it to submission instead.

It does not mean any country must allow it to be imported and used.

How come you haven’t posted your stock purchases?

feel free to refute any of my statements...