IHL 0.00% 4.1¢ incannex healthcare limited

Ann: IHL-675A Pre-IND meeting with FDA update, page-29

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  1. 1,235 Posts.
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    April 21st is the date by which the FDA should have replied back with their feedback.

    In my understanding:

    - A positive outcome would either validate the plans Incannex has outlined, or even provide improvements that shorten the timeline and lessen expense. If we're really lucky, it is my understanding that we could receive early indication of intent for this drug candidate to head towards emergency use.

    - A "negative" outcome, if one can even really call it that, would be for the FDA commentary to present the need for Incannex to deviate significantly from its current proposal. But it wouldn't really be negative: the important thing is that Incannex receives the proper guidance, so they know exactly which hoops to jump through to satisfy the FDA. The only true negative outcome would have been if the FDA had refused to enter into this conversation. They've entered into it, which means they see the potential.
 
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