Replies to post #322649 on Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

Meeting/briefing packages:

https://www.accessdata.fda.gov/cder/sb-navigate/topic3/topic3/da_01_03_0400.htm

Type A: Submit meeting package along with meeting request
Type B and C: Submit meeting package at least 1 month before formal meeting
Meeting packages should include the following:

Product name and application number (if applicable)
Chemical name and structure
Proposed indication
Dosage form, route of administration, and dosing regimen (frequency and duration)
An updated list of sponsor or applicant attendees, affiliations, and titles
A background section that includes:
A brief history of the development program
The events leading up to the meeting
The status of product development
A brief statement summarizing the purpose of the meeting.
A proposed agenda.
A list of the final questions for discussion grouped by discipline and with a brief summary for each question to explain the need or context for the question.
Data to support discussion organized by discipline and question.