IHL 0.00% 4.1¢ incannex healthcare limited

Ann: IHL-675A Pre-IND meeting with FDA update, page-22

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  1. 7,189 Posts.
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    Here is a question to those knowledgeable on the FDA’s Pre-IND process:

    The FDA process guidance states that it agrees to a pre-IND meeting based on certain conditions and if grated the meeting requestor should provide meeting materials for the meeting per this guidance:
    https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-and-industry-assistance-frequently-asked-questions-pre-investigational-new-drug-ind

    Per today’s Ann, FDA aims to respond to IHL by 21st of April.

    https://hotcopper.com.au/data/attachments/3034/3034005-6aa7aa9ffc92a206ad4a6516ff538d44.jpg

    Is a meeting recalling happening or will FDA will review the information package and provide IHL a response by 21st of April? Or will a face-to-face (or video) meeting take place on or before 21st? I am unclear on that part. Appreciate some clarification.

 
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