Peer-Reviewers were fed what NWBO wanted them to see, not the failed primary endpoint, or the protocol changes, or the change in comparator. Peer-reviewers are not FDA reviewers who have a dozen years of knowledge, while Peer-reviewers get a week or so of spoon fed information. Who different process, with only the FDA's counting. And FDA wasn't buying it.
FDA does their own reviews of the data. Publication in peer-reviewed journals is neither required nor sufficient for approval; FDA approvals rest on sponsor-submitted data, not on journal articles. There is extensive evidence that many pivotal trials supporting approvals are unpublished or only partially published, which underscores that FDA relies on the full regulatory dossier rather than the peer-review literature.
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