IHL 0.00% 4.1¢ incannex healthcare limited

General discussion, page-10835

  1. 4,243 Posts.
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    @MickeyMantle536
    agree and same page, IHL are not blinkered or under any illusions of the down scheduling process of psilocybin or the potential to 'trigger' that process with the FDA

    as per pg 2 of IHLs listing prospectus summary as submitted to the nasdaq....

    'Psilocybin is a schedule I substance but there is substantial peer reviewed literature to support that there is a low chance for abuse. It is expected that once the FDA approves a psilocybin drug product, such as our drug candidate targeting GAD, this will trigger a rescheduling.'

    clearly on the companies radar moving forward on the back of those clinical outcomes - so potentially once the FDA are 'triggered' into the rescheduling ( either by IHLs' drug candidate or another submitted candidate from another pharma co.) it will provide impetus for the TGA to revisit the process, as this would directly their grounds for objection.

    they go on....
    Our current cash position is sufficient to complete the studies that have already commenced as well as the pivotal Phase 2 clinical trial for OSA. Future capital raises, including this offer of ADSs will be required to fund additional Phase 1, 2 and 3 studies as well as other development activities required by regulatory bodies, such as the FDA.

    Seems the company is intent to build a compelling case re potential to reschedule psilocybin, albeit in the early stages - think the US market will find this pretty compelling stuff

 
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