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    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://hotcopper.com.au/data/attachments/5381/5381751-5b13fa6ccb40f71a52cd78c720ece109.jpg
    https://www.ideagen.com/thought-leadership/blog/pre-ind-meeting-fda-your-need-to-knows


    https://hotcopper.com.au/data/attachments/5381/5381754-a5b876a7702a34514e2731206bea2553.jpg


 
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