Replies to post #583154 on NorthWest Biotherapeutics Inc (NWBO)

[Smokey21]

I believe whenI asked where those expenses would be, I was told they were under R&D expense. So, you can’t say definitively they are not in the P&L.

[hoffmann6383]

False. Compassionate use cases are real. Read the 10K.

Have a good one friend!

During 2021, initial licenses were obtained for operations in the Sawston facility, after technology transfer from the London facility, recruitment of technical personnel, development of some 1,000 regulatory documents, and buildout of Phase 1A of the facility. The initial licenses included a license from the Human Tissue Authority (HTA) for collection and processing of human cells and tissues, and licenses from the Medicines and Healthcare Products Regulatory Agency (MHRA) for manufacturing for clinical trials and compassionate use.

GMP production of DCVax-L products for compassionate use began in the Sawston facility in February 2022, after the licenses were obtained in Q4 2021, and continued throughout 2022. In parallel, extensive activities were conducted throughout 2022 to further develop the operations, personnel, regulatory documents and data necessary to apply for a commercial manufacturing license for the Sawston facility. The application package was submitted at the end of June, and reviewed by the regulatory authorities over the following months. An initial onsite inspection by regulatory authorities took place in October for the commercial license application, and also served as the annual review/renewal inspection for the prior licenses for compassionate use and clinical trial manufacturing. Further submissions and interactions with the regulator took place between October and February, and a follow-up inspection took place in early February 2023. The Company is now awaiting any further requirements or communications from regulators.

In parallel, production of DCVax-L products for compassionate use continued in the London facility. In the US, the Company entered into contract discussions for resumption of manufacturing capacity there.

We have worked with several such manufacturers, in several different locations, during various periods of our clinical trials and our compassionate treatment programs, including Advent BioServices, Cognate BioServices and the Fraunhofer Institute.

On November 8, 2019, the Company entered into an Ancillary Services Agreement with an initial eight-month term for the U.K. Facility Development Activities and Compassionate Use Program Activities, which is described in Note 10 of the financial statements included in the Company’s 2019 Annual Report.