NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Flipper, thank you for providing the purported list of MAA validation PRs. I stand by my earlier comments found here. There are examples of MAA validation PRs (none of which are found below), but they pale in comparison to the numbers of companies that choose not to PR validation.

My comments to your list of purported MAA validation PRs is found below in red.

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/

Next, we saw the promotion of this false information, with one poster actually checking the data before chiming in:



Anyways, I hope this helps clear up any misinformation as to the unlikely MAA validation PR.

Have a good new years Mr. flipper.