Yes, I do know that FDA’s own database is full of references to peer-reviewed medical literature…
Regulatory agencies such as FDA & MHRA can & do consider independently peer-reviewed medical literature as part of their own analysis & review process.
For example, in their BLA Review Package for the approval of the Alzheimer’s drug Donanedab, the FDA cites two JAMA peer-reviewed publications as part of their analysis of the drug’s safety & efficacy:
The FDA’s public database that houses review packages (including FDA’s scientific & regulatory analysis of BLAs) is published on FDA’s website. Use the search bar to search by drug name or BLA number…
You can search & find as many examples as you want of FDA’s citations of independently peer-reviewed analyses published in JAMA, JAMA Network, NEJM, Lancet, etc., etc.
It’s easy to forget the immense importance of independent peer review. It plays a critical role worldwide in regulatory review & clinical practice, & the status/validation it brings is invaluable for a biotech company.
In addition to independently peer-reviewed papers in JNS, Nature Comms, & JAMA Oncology, NWBO’s pipeline also has the validation of rigorously peer-reviewed grants awarded by the 🇺🇸U.S. NIH-NCI & the 🇺🇸U.S. DoD. Those government agencies have supported & are currently supporting the clinical development of DCVax®-L & Roswell’s aDC1 platform.
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