Let me preface this by saying that I am enjoying these well-thought out, educated posts.
... but.
I have more questions.
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Melbourne, Australia, 5 July 2024 – InhaleRx Ltd (ASX: IRX), (‘IRX ‘or ‘the Company’an Australian healthcare company developing unique inhaled drug-device products to address unmet medical needs in the pain management and mental health sectors today announced that the U.S. Food and Drug Administration (‘FDA’
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I understand the FDA concerns were related to safety and the presentation/assessment of non-clinical data. How is the company mitigating this risk... doesn't "non-clinical" mean tested against animals (non-human testing)?
Is the company relying heavily on the Australian trial results to remove the temporary FDA suspension?
IRX 616a World 1st Fast Acting Non Addictive Anxiety Solution, page-6
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