Was not the case i the external comparator trials. Critics of the trial documented the external comparator trial profiles in their peer-reviewed article in The Neuro-Oncology Journa. Read the publication, it outlines the comparator trials did not get the benefit of the healthiest GBM patient sample that the NWBO screener created.
"Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination (DCVax-L) in glioblastoma: breakthrough or fata morgana?" Authors: Matthias Preusser, Martin J van den Bent
The FDA partial hold took two years and then NWBO agreed to end the trial prematurely. FDA holds are due to safety. NWBO never published ANY explanation as to why, but they certainly knew. Safety issues should always be included in a trial publication manuscript, but Dr. Bosch chose NOT to include it. But the FDA knows and it will be relevant for the application review.
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