NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Gro,

“They only see what NWBO feeds them”

So HyGro & I get to see more than the RAs do? How could anyone stop any RA from reading JAMA? 😶

Fact ✅️: Of course independent peer review counts, especially if something was published about safety—how could something like that be ignored in a comprehensive regulatory review?

In fact, FDA cites JAMA in their review analysis reports. Obviously, peer-reviewed medical literature is never the sole basis for approval, but the FDA & other RAs cite journals such as JAMA all the time in their review documents.

Examples:

For Lorcaserin (weight loss drug), the NDA review references a JAMA meta-analysis, & the FDA included a reference to JAMA’s published analysis:
“A meta-analysis recently published in JAMA (Khera et al, 2016) …”
FDA Source Link

For Donanemab (Alzheimer’s drug), the FDA clinical review lists JAMA Neurology articles as references & in the BLA review for donanemab (BLA 761248), the FDA listed references that included JAMA Neurology articles:
“References … JAMA Neurol., 78(4):445-453.”
FDA Source Link

There are countless specific examples of FDA drug review documents where they explicitly cite a JAMA or JAMA Network publication in the regulatory review package. It’s a verifiable fact that regulators can & do consider peer-reviewed literature (including JAMA journals) as part of the totality of evidence they look at & consider:

“JAMA Oncol. 2021 Dec 1;7(12):1824-1832. doi:10.1001/jamaoncol.2021.4932 …”
FDA Source Link

“JAMA Netw Open. 2019;2(8):e198890. Monk BJ, Grisham RN, Banerjee S …”
FDA Source Link

FDA’s NDA content regulation says an NDA must contain reports of the applicant’s investigations and “all other information about the drug pertinent to an evaluation of the NDA… obtained by the applicant from any source.”

All clinical trials are relevant too, including small or ongoing investigations. Again, how could an applicant exclude safety data that was collected from a small peripheral trial because it’s not data they want the regulators to see? Of course they couldn’t exclude it & exclusion would not be possible to achieve even if a company tried to exclude a trial or any published analysis.