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Step 4 Unless your device is in the lowest risk class, your Sponsor submits your Manufacturers Evidence for the TGAs review and acceptance

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Since the drug candidate has already been translated into the clinic for several decades, its established pharmacological properties and safety and side-effect profiles expedite preclinical and clinical assessment for the treatment of COVID-19

Safety Concerns & Considerations Hormonal Feedback Mechanisms : Testosterone and other hormone therapies can shut down the natural production of hormones, which is a critical concern when combining therapies