NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

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 There is extensive evidence that many pivotal trials supporting approvals are unpublished or only partially published, which underscores that FDA relies on the full regulatory dossier rather than the peer-review literature.

https://journals.plos.org/plosmedicine/article?id=10.1371%2Fjournal.pmed.0050191