NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

See attached link. It is not clear to me that the EMA equivalent is deemed acceptable and regardless the discrepancy between the two registries was problematic. DI does not always speak with full knowledge based on reporting I have read here. My phone interaction with him led me to deem speaking with him useless not because of him personally but because he plays his role well.

https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

1. Registration

The ICMJE’s clinical trial registration policy is detailed in a series of editorials (see News and Editorials and FAQs).

Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s trial registration policy.

ICMJE uses the date trial registration materials were first submitted to a registry as the date of registration. When there is a substantial delay between the submission of registration materials and their posting at the trial registry, editors may inquire about the circumstances that led to the delay.

The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. The ICMJE does not define the timing of first participant enrollment, but best practice dictates registration by the time of first participant consent.

The ICMJE accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) that includes the minimum acceptable 24-item trial registration data set or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP.