Anavex Life Sciences Corp (AVXL)

[Steady_T]

There are clearly defined meeting types for meeting with the FDA. Each meeting type has its own requirements in terms of time frame, required submissions, subject matter areas etc.

The meeting request, regardless of the method of submission, should include adequate information for the FDA to assess the potential utility of the meeting and to identify FDA staff necessary to discuss proposed agenda items. The meeting request should include the following information:
1. Product name.
2. Application number (if applicable).
3. Chemical name and structure.
4. Proposed indication(s) or context of product development.
5. Type of meeting being requested (i.e., Type A, Type B, or Type C). If a Type A meeting is requested, the rationale should be included.
6. A brief statement of the purpose and objectives of the meeting. This statement should include a brief background of the issues underlying the agenda. It also can include a brief summary of completed or planned studies and clinical trials or data that the sponsor or applicant intends to discuss at the meeting, the general nature of the critical questions to be asked, and where the meeting fits in overall development plans. Although the statement should not provide detailed documentation of trial designs or completed studies and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarizes major results.
7. A proposed agenda.
8. A list of proposed questions, grouped by discipline. For each question there should be a brief explanation of the context and purpose of the question.
9. A list of all individuals with their titles and affiliations who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants.
10. A list of FDA staff, if known, or disciplines asked to participate in the requested meeting.
11. Suggested dates and times (e.g., morning or afternoon) for the meeting that are within or beyond the appropriate time frame of the meeting type being requested.
12. The format of the meeting (i.e., face to face, teleconference, or videoconference).

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https://www.fda.gov/media/72253/download