NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Peer-reviewers were not provided the complete information about the deficiencies in the trial. FDA partial hold on the trial, preventing further recruiting is a clear identification of a deficiency in the trial -- it was NOT reported to the peer-reviewers in the SAP material that was used as the basis of the manuscript. NWBO refused to publicly identify the cause of the FDA partial hold and ended the trial prematurely ration that deal with the FDA on the issue. FDA clearly knows the issue and found it egregious enough that they intervened.

NWBO repeatedly reported the confounding of the naïve OS endpoint in their SEC 10K annual report filing. NWBO indicated that issue in the SAP provided to the reviewers but did not address it other than report their intent to analyze the issue in the future. It is a substantial issue that should have been addressed in the manuscript but was not. Double dosing ~90% of the patients when the external comparators would not have done so, biases the analysis.

The post hoc, data dredged recurrent OS endpoint was not identified as such in the SAP or in the manuscript. This is a significant issue that should have been reported and included in the publication.

All of the issues will be known by regulators, particularly FDA and will not be dependent on NWBO providing all the data.