From what I recall Steven stating, we will be seeking FDA approval which the TGA here recognise (but still requires a signature by the TGA to run trials here or export drugs to the US for trials there from what i have read).
Whilst OmniCAR requires IND (Investigational New Drug) approval, we only require one... regardless of the number of antigens being targeted.
https://www.ideagen.com/thought-leadership/blog/pre-ind-meeting-fda-your-need-to-knows
From what I recall Steven stating, we will be seeking FDA...
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