Sorry, peer-reviewers know the information that the authors provide. Protocol, SAP, reported data. Nowhere did NWBO or the authors include the information of the FDA partial hold, the reason for it in their manuscript. It is an error of omission.
Peer-reviewers have very limited time for reviewing manuscripts. It is a part-time job that depends on authors being honest and providing all the evidence. NWBO's manuscript depended on Dr. Bosch and his company controlled statistical vendor for much of the findings.
But their are clear issues. NWBO screening
"Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded. These primary treatments must be completed at least two weeks prior to first immunization." These are the patients that will have the best possible prospect of survival. but this is NOT a requirement for any of the external comparator trials who had patients with lower prospects of survival because of less complete resection.
Look at the other trial resection requirements -- they are much lower prospect of survival to begin with: "Must be undergoing surgery that is clinically indicated, and eligible for resection with the expectation that the surgeon is able to resect at least 2 gram of tumor for lysate and research with low risk of inducing neurological injury." - no requirement for gross or near total resection.
This one of the primary bias between the NWBO trial and the external comparators that did not require complete or near complete resection. This has been verified by researchers who have criticized the NWBO trial for considerable bias that raises serious questions of the trials validity.
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