Here are 18 (see below) Hoffman, not one, and it just scratches the surface.
(Also Bard came to the opposite conclusion when I asked it, you are confusing premature announcements with concurrent validation announcements.)
(Also, you recently stated you’d be “pleasantly surprised” if they announced validation.🤔)
If we followed your advice to not announce validation (which is against NWBO’s position), the first thing KG would say is, look, those guys wouldn’t even save their own skins by announcing acceptance/validation by a regulator.
Second, here is a sampling I created, with AI help, of drug and biologic companies announcing MHRA validation. It barely 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)
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)
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)
4.
Aeglea Biotherapeutics Announces MHRA Validation of Marketing Authorization Application for Pegzilarginase for Arginase 1 Deficiency (August 15, 2023)
5.
Albireo Pharma Announces MHRA Validation of Marketing Authorization Application for Bylvay® for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) (July 7, 2023)
6.
BioMarin Pharmaceutical Announces MHRA Validation of Marketing Authorization Application for Palynziq® for the Treatment of Phenylketonuria (PKU) (June 15, 2023)
7.
Ipsen Announces MHRA Validation of Marketing Authorization Application for Cabometyx® (cabozantinib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) (May 24, 2023)
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)
9.
UCB Announces MHRA Validation of Marketing Authorization Application for Bimzelx® (bimekizumab) for the Treatment of Moderate to Severe Plaque Psoriasis (March 8, 2023)
10.
Vifor Pharma Announces MHRA Validation of Marketing Authorization Application for Veltassa® (patiromer) for the Treatment of Hyperkalemia (February 1, 2023)
11.
PTC Therapeutics Announces MHRA Validation of Marketing Authorization Application for Upstaza® (eladocagene exuparvovec) for the Treatment of AADC Deficiency (January 4, 2023)
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)
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)
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)
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)
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)
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)
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, )
