IHL 0.00% 4.1¢ incannex healthcare limited

Ann: Incannex Development Update for IHL-42X, page-17

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  1. 7,265 Posts.
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    Hi @thevinnys can I confirm my understanding of the Ann today and the timelines for the OSA phase 2/3 trial and next steps?

    Q1 2023 file for USA IND with FDA

    Q2 to Q3 2023 if no objection from FDA activate trial sites and commence recruitment - 20 to 30 sites with a total of 116 patients involved

    Q3 2023 to Q3 2024 (12 months) conduct BA/ BE trials

    Q4 2024 to Q1 2025 apply for FDA drug commercial approval

    Btw, why is the trial mentioned to be conducted at CMAX while it is conducted across all the trial sites?

    Thanks in advance.


    (any errors or omissions are my own. No advice)
 
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