NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

DavidW2, Despite the October 1, 2021 Lancet Oncology article entitled "Leveraging external data in the design and analysis of clinical trials in neuro-oncology" that appears to justify the utilization of our new phase 3 trial endpoints, I do believe that inclusion of the new endpoints in clinicaltrials.gov should still be postponed. I believe the company has been right in doing so.

At this time, despite the Lancet Oncology article, the inclusion of the new endpoints could be challenged by the wolf packs that have always been eager to attack NWBO, its trials and the SP.

I believe that the update and revisions in clinicaltrials.gov should take place right before the TLD and the publication which together will amply legitimize the comparison of data obtained from the new endpoints to data obtained from contemporaneous externally controlled data. A stellar TLD and article will then neutralize any attacks that may be launched against the trial and NWBO.

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00488-5/fulltext