Comment from Azunic AI
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Summary: Jerry Henley, CEO of Azunic AI, expresses full support for the Expedited IND initiative and proposes a collaborative partnership with Australian ethics committees and regulatory experts. He suggests establishing a bilateral relationship to exchange data and operational expertise to ensure the pilot's success and avoid potential risks.
Re:Expedited Investigational New Drug Pilot Program; Request for Information (91 FR 37996)
We at Azunic AI fully support the Expedited IND initiative and we would like to offer help in a working bridge with the FDA. We are currently in talks with the Australian Ethics committees with great responses from them.
We hope to hear back from you.
Please see file below and I am also sending in a letter via mail.
Regards,
Jerry Henley
CEO, Azunic AI