Replies to post #580775 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Good stuff. Thanks for sharing ATL!

[marzan]

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

[flipper44]

Excellent. — Chatflip.

[Springbok80]

What the FFF does not comprehend, because he is so stupid, is that Chatgpt...Is actually saying I am not going to write anything like AF because he is spreading false narratives which have no basis in scientific fact...

[Doc logic]

ATLnsider,

Linda Powers has been lobbying for this classification for years and the regulators finally bought in. Now why do you suppose Linda has been saying that L and Direct are “the same”? If an autologous DC is equal to an autologous DC, or eventually to a matching donor DC, then the only difference is the stage of activation/maturation it is in at any given point in time, where the DCs are introduced to the antigen targets and how effective it is made to be (think of a potentially situationally adjusted hyperactive DC load) by that activation/maturation since the mechanism of action for Direct is “the same” in antigen uptake, presentation and immune response processes as L. Simple right? I like where Linda is going with all of this ; ). Best wishes.

[antihama]

A "Even Cowgirls Get the Blues" thumbs up! I would say a "big" thumbs up but that would be redundant.

[marzan]

ATL, wish you send this content you put together as a comment for the FDA-2022-D-0286 Tissue Agnostic guidance that FDA released in Oct 22 and mail it out to them ASAP. The Comment Period is still open. Thank you very much for all you do. We all owe you big time when the RAs approve DcVaxL as tissue Agnostic or MOA. Please do. You can.