Regulatory Open Forum

Our product has been granted BTD and this includes a meeting with FDA for an initial multidisciplinary discussion and feedback (Type B mtg).  The letter indicates that we need to submit a meeting request and briefing document outlining our integrated development and regulatory plan.  Is it expected to also ask concurrence on specific plans as we typically do for FDA meetings or is this expected to be more of a discussion?

Similar to a Type B meeting, present plans and ask for concurrence/advise!