This newest PR, if it is to be believed, says that NNVC didn't submit a pre-IND meeting request on March 26 as announced in their PR, and hasn't yet submitted any request. They are only just preparing the documents now to eventually submit a request.
"The Company also reports that it is preparing the pre-IND Meeting Submission Documents as required by the US FDA."
The past two PRs about pre-IND meetings contradict each other. The FDA provides detailed instructions for everything that is required to submit a meeting request. Either NNVC followed the instructions and actually submitted a meeting request when the said they did in their March 26 news release, or they didn't.
It's not a two-step process where one first requests to file a request, and then second submits the actual meeting request. That is, NNVC was lying in their first PR.
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:
1. The proposed meeting format (i.e., face to face, teleconference/videoconference, or WRO).
2. The date the meeting background package will be sent by the requester (see section VII. A., Timing of Meeting Package Submission). Note that meeting packages should be included with the meeting request for all Type A meetings and those Type C meetings where the objective is to facilitate early consultation on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use.
3. A brief statement of the purpose 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 requester 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 the details 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.
4. A list of the specific objectives or outcomes the requester expects from the meeting.
5. A proposed agenda, including estimated times needed for discussion of each agenda item.
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.
7. A list of requested FDA attendees and/or discipline representative(s). Note that requests for attendance by FDA staff who are not otherwise essential to the application’s review may affect the ability to hold the meeting within the specified time frame of the meeting type being requested. Therefore, when attendance by nonessential FDA staff is requested, the meeting request should provide a justification for such attendees and state whether or not a later meeting date is acceptable to the requester to accommodate the nonessential FDA attendees.
When submitting a meeting request, the requester should define the specific areas of input needed from the FDA. A well-written meeting request that includes the above components can help the FDA understand and assess the utility and timing of the meeting related to product development or review.
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