MSB Trading - Aug 2020 on, page-1369

Don't try to read anything into it - it is just the way it is done, and for good reason.

MSB is well aware of the potential issues from their ongoing discussions with the agency, so no question of going in blind. Their submission specifically seeks to address those issues.

Don't forget, the panel is not the FDA - they will not be aware of all the discussions between the sponsor and the agency - they need to be brought up to speed, and in particular on what points the FDA wants their expert opinion.

It is not a question of giving the sponsor additional time - because if these issues are determined to be substantive, it will take a long time for the sponsor to rectify them (eg additional trial - don't forget the FDA normally requires two Phase 3 studies - we are hoping the EAP will be accepted as one of those studies, but there is no guarantee of that).