We still don't really know why the study was bungled,
We were told exactly what happened and what needed to be done. Some of the 21 samples from the second cohort need to be replaced because the cancer from those samples started in other parts of the body and spread to the lungs. Here was a portion of the PR that clearly explained this.
We thought we had secured sufficient samples, but further investigation showed that some of these lung cancer patients do not fit the FDA-approved criteria for inclusion in the positive control group. Some of the patients’ cancer is located outside the lung cavity. Under the protocol submitted to the FDA, these patients must be excluded from the study,” Cousins said
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