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manibiotech

12/28/25 5:09 PM

#804875 RE: Roman516 #804874

"as it appears that the FDA path would have coats NWBO $$$ to file "
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brazen22

12/29/25 8:59 AM

#804953 RE: Roman516 #804874

Could you explain your research method—empirical/quantitative, or case-study/investigative? Because based on your posts, it looks like the hand-waving method dressed up as research. Claiming FDA approvals can have serious consequences is like saying ‘if I invest everything I have in NWBO, I could very likely lose everything’—true, but not an argument. Yes, medicine carries risk, and safety issues are exactly why the FDA has defined submission standards, review trails, and written actions. Every therapy is a benefit–risk tradeoff—particularly in oncology—so ‘people can die’ is not evidence of corruption, incompetence, or negligence; it’s why regulators demand data, impose labeling/REMS when needed, and monitor post-approval safety.

The ‘FDA would cost $$$’ excuse is a red herring. MHRA costs money too, and the filing fee isn’t the gating item—the dossier/CMC work is. NWBO’s own 10-K shows they’ve already spent roughly $18M on consultants/legal/document preparation and ‘multi-millions’ on facilities. So stop pretending fees explain anything. The non-speculative facts are simple: either there’s an FDA submission and written agency actions to cite, or there isn’t. That’s not ‘IMPO’