NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

marzan
ATL/flipper/doclogic/TDD/senti/iwasadier/ILT/Horseb4ct/all longs, please login to the FDA guidance document Tumor agnostic one D-0286 and please write to FDA as many comments as possible on the need for Tumor Agnostic approval or Mechanism Of Action approval to DcVaxL. See the 10 comments posted there from PFE, MRK, GSK, Novartis and others that the BPs are asking Tumor Agnostic label to their CI therapies like Keytruda. We should do the same for DcVaxL which is far better than the CIs. NWBO LP or LL may not want to post their comment there to avoid the notion of Front Running or so as the Company is in the process of seeking regulatory approval for GBM. There are two methods of posting our comments as that from the investors or public: 1) online and 2) if online posting doesn't work, it says mail it to FDA at the address given like Dr. Beckman did with a Return Receipt.

Let us all flood the site posting our comments with DcVaxL as Tumor Agnostic please. Thanks in advance.
marzan

Re: ATLnsider post# 580775

Monday, March 27, 2023 12:46:47 PM

Post#
580792
of 580971
ATL, is this the right FDA guidance on tissue agnostic? The comment Period is still open. We should all comment citing DcVaxL and MOA. Let us do it. TIA.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tissue-agnostic-drug-development-oncology

https://www.regulations.gov/docket/FDA-2022-D-0286/comments
Bullish
BULLISH