NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Gro,

Thanks for asking 😶

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.