Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"We are curious if the Term Sheet BP will be attending."

I wonder if such a thing fits the FDA's meeting rules.

The meeting request should include the following information:

1. The application number (if previously assigned).

2. The product name.

3. The chemical name, established name, and/or structure.

4. The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2)).

5. The proposed indication(s) or context of product development.

6. The meeting type being requested (i.e., Type A, Type B, Type B (EOP), or Type C).

7. Pediatric study plans, if applicable.

8. Human factors engineering plan, if applicable.

9. Combination product information (e.g., constituent parts, including details of the device
constituent part, intended packaging, planned human factors studies), if applicable.

10. Suggested dates and times (e.g., morning or afternoon) for the meeting that are consistent
with the appropriate scheduling time frame for the meeting type being requested (see
Table 2 in section VI.B., Meeting Granted). Dates and times when the requester is not
available should also be included.

11. A list of proposed questions, grouped by FDA discipline. For each question there should
be a brief explanation of the context and purpose of the question.


The meeting request must include the following information:
...
6. A list of planned attendees from the requester’s organization, including their names and titles. The list should also include the names, titles, and affiliations of consultants and interpreters, if applicable.



https://www.fda.gov/downloads/Drugs/.../Guidances/UCM590547.pdf