OTP Pre-BLA Meetings

Prior to the Sponsor Meeting

• OTP will send the preliminary response according to the timeline indicated above in Table 5.
• The sponsor is expected to respond to OTP’s preliminary responses according to the timeline indicated above in Table 5. 
• The sponsor should identify which of the original questions in the briefing package they wish to discuss and list the questions in the proposed order of discussion. As a general rule, the order of discussion is usually the order of importance to the sponsor.  When referencing questions, the sponsor should use OTP’s preliminary responses document numbering format.
• After receiving OTP’s preliminary response, the sponsor should not submit new questions and new information (e.g., alternative approaches or new proposals to address OTP comments) that were not previously submitted in the original briefing package. OTP preliminary responses are prepared after deliberative review, and usually include cross discipline internal discussion, of the original meeting package and questions.  OTP will not have adequate time to review new material and have sufficient inter-discipline internal discussion necessary to prepare answers to new questions.  Therefore, sponsors should thoughtfully prepare their meeting package and questions. 
  • In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTP’s preliminary responses or discussion at the meeting.  Such new questions/alternative approaches should be submitted as an amendment to the sponsor’s existing IND.

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During the Meeting

The meeting is the sponsor’s opportunity to obtain clarifications on OTP preliminary responses. As stated above, during the meeting the OTP team will not be able to provide feedback on new information (e.g., new question, alternative approaches or new proposals to address OTP comments) that was not previously submitted in the original briefing package.

Sponsors may choose to make a presentation at the beginning of the meeting. However, because OTP staff will be familiar with the meeting package content and questions, OTP recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTP’s preliminary responses to the sponsor’s questions. 

OTP recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items.

Meeting Summary

OTP will issue meeting summary within 30 calendar days after the meeting.  OTP’s version of the meeting summary is official and the final record of the meeting.  The OTP meeting summary is not a meeting transcript, but focuses on any clarifications (e.g., of unclear preliminary responses), agreements and disagreements, and action items as discussed during the meeting. 

The sponsor may submit their version of the meeting summary to the file to summarize their understanding of issues discussed at the meeting. However, OTP may not review such submissions; therefore, the absence of an OTP response to such submissions does not imply OTP concurrence with the sponsor’s version of the meeting summary.

If sponsors disagree with the content of OTP’s meeting summary, OTP’s meeting summary will not be altered except to correct a substantive mistake for the record (on extremely rare occasions).

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Requests for Clarification

A Request for Clarification may be sought after a Type B Pre-BLA meeting, to ensure the requestor’s understanding of OTP's feedback provided in a preliminary response (if the formal meeting was canceled), meeting summary or written response issued by OTP.

Find out more about Requests for Clarification