NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Wrong Hopeforthefuture3‼️ The FDA only use to require patient-level data when the external control arm (ECA) was comprised of real world data (RWD) or real world evidence (RWE):



https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug

This is an often repeated FUDster lie that is intended to deceive and mislead NWBO investors, and to help support the untruth that the FDA will not accept the DCVax-L phase 3 trial data and results.

As we all know, the DCVax-L phase 3 trial data results were analyzed and peer-reviewed by using an ECA, but the ECA did not contain any RWD or RWE.

NWBio did not use any RWD or RWE, instead they used the control group data from 7 external pooled contemporaneous randomized controlled trials (RCTs), not RWD or RWD.

Here is how RWD is defined by the FDA, and some examples of RWD:

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

Examples of RWD include data derived from electronic health records (EHRS); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. RWD sources (e.g., registries, collections of EHRs, administrative and medical claims databases) can be used for data collection and, in certain cases, to develop analysis infrastructure to support many types of study designs to develop RWE, including, but not limited to, randomized trials (e.g., large simple trials, pragmatic clinical trials) and observational studies (prospective or retrospective).6