I condensed my earlier post into one clear example (but there’s a million published examples)…
Regulatory agencies such as FDA & MHRA can & do consider independently peer-reviewed medical literature as part of their own analysis & review process.
One 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.
I’m glad you raised this again, because it’s easy to overlook 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 publications in JAMA Oncology, Nature Comms, & JNS, 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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