NorthWest Biotherapeutics Inc (NWBO)

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Was everyone surprised by the following unpublished paper? Why cannot the longs expect another surprise? At least it is amusing for the longs and makes the shorts shudder. BTW, has anyone pondered the possibility that the contract on RWE of rare cancers awarded to McKesson by FDA may have something to do with DCVax-L?

Glioblastoma Molecular Characteristics and Immune Microenvironment Associated with Survival Outcomes in Patients Treated with Dendritic Cell Vaccination
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2734629

Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration


FDA Selects Ontada to Investigate the Natural History of Rare Cancers Treated in the U.S. Community Oncology Setting

https://www.mckesson.com/About-McKesson/Newsroom/Press-Releases/2023/FDA-Selects-Ontada-Investigate-Natural-History-Rare-Cancers/
BOSTON, Oct. 11, 2023 — Ontada®, a McKesson business dedicated to leveraging oncology real-world data and evidence, clinical education, and provider technology, was awarded a competitive contract with the U.S. Food and Drug Administration (FDA) to advance the use of real-world data (RWD) in the U.S. community oncology setting. The research aims to strengthen the scientific understanding of the natural history of rare cancers by leveraging Ontada’s community oncology footprint, unique RWD, and experience in real-world research (RWR).

The goal of the study is to enhance understanding of how patients with rare cancers present and are treated in order to inform drug development for life sciences companies and the FDA. Study objectives include:

Identifying pivotal components of the community oncology patient’s journey impacting treatment decisions, patient outcomes, and the relationship of patient characteristics to the patient’s journey.

Describing the patient journey in the community cancer setting relative to national registries and other public data sources.

Identifying insights to inform care and clinical research.

Real-world data and clinical context are paramount to fuel future research in oncology. A deeper understanding of how rare cancers are treated in the community oncology setting requires a line of sight into what is happening in clinical practice. Ontada’s unique data footprint will allow the FDA to further its understanding of a patient population with rare cancers that historically has been underrepresented in studies.

Ontada is uniquely qualified to study the rare cancer journey because of its deep connection with the largest network of community oncology providers in the U.S. That connection allows Ontada to provide a robust view by leveraging approximately 2.4 million patient records from a diverse group of patients.

“We’re honored to have the opportunity to collaborate with the FDA to gain a deeper understanding into a space we are devoted to advancing and serving - community oncology,” said Christine Davis, president of Ontada. “It is exciting to see where this research will take us as it aligns with our mission of transforming the fight against cancer and improving patient lives.”