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Re: Gus1212 post# 667421

Friday, 01/26/2024 2:00:35 PM

Friday, January 26, 2024 2:00:35 PM

Post# of 701421
Gus, NWBO would not be allowed to market off label.

Many do not understand what "market" means. NWBO would not be allowed to manufacturer -L based on non approved tumor cells and sell it commercially under the approved label.

There is some off label use that could and would happen. But they will be limited to the fringe cases. Non GBM brain tumors. Patients who have low WBCs. Patients who cannot get off steroids, patients with previous use of XYZ, patients with other health issues and similar stuff.

OTOH, If a doc sent in a a lung cancer sample to have -L produced commercially it would absolutely be illegal for NWBO to manufacture and sell it.

OK, this is US law. I am 99.999% certain UK law is the same though.
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