NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Thanks Nick119.

I e-mailed the FDA on Dec.10, 2021.
See email attached from FDA replying to my inquiry:
Dec.10,

Dear XXXXX:

Thank you for your recent inquiry to the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER). CBER is one of seven centers within FDA responsible for the regulation of many biologically-derived products including blood intended for transfusion, blood components and derivatives, vaccines, allergenic products, tissue, and cell and gene therapy products.

Unfortunately, we cannot provide you with a timeline for the release of the final guidance.

If you would like to comment on FDA’s December 2019 “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry,” you can access the document on the regulations.gov website. To submit your comment, click on the “Comment Now” box on the top of the page. The direct link to the Docket Folder Summary page can be found here.

If you would like to receive updates regarding product approvals or any other CBER-related news, you may subscribe to our mailing list on our website at: https://www.fda.gov/vaccines-blood-biologics/resources-you-biologics#subscribe.

We hope this information is useful. If you need further assistance, you may contact our office at [e-mail] or 1-800-835-4709.

Sincerely,

Amy Temple
Health Communications Specialist
Center for Biologics Evaluation and Research
Office of Communications, Outreach and Development
U.S. Food and Drug Administration
Tel: [phone]
[e-mail]