Yep . It will take some serious lobbying / connections / public opinion , whatever to have FDA amenable to do things outside the box . Not sure what management is capable of in any of those regards . Or maybe application under international program after being approved elsewhere . But MHRA had no problem not covering Novacure after being approved and paid in US and EU (EMA).So it's uncharted territory in my opinion and not all rosy as some of these minions make it to be.
Meirluc - The leadership overhaul and subsequent initiatives made by the FDA, NIH, and HHS should see NWBO well positioned to flex it's vast data-rich dossier to a much more welcoming regulatory environment.
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