It was 9-1 in the end as one of the committee members had supposedly accidentally voted no when she meant yes. I am a holder of MSB as well as PAR. I actually stayed up and listened to a good portion of the briefing and if PAR need to go through an ODAC as a pre-cursor to their FDA approval then there is much to learn from MSB's experience. Si and his team were unflappable and had the science so far in their pocket it was almost embarrassing at times as they virtually had to school the FDA and some of the doctors on the panel. As many of you will know, this was after the FDA produced briefing notes which almost looked like they were trying to trip MSB up and cast doubt on some aspects of their application (it may well have been the opposite and an opportunity for MSB to provide answers to some lingering questions). The science has to be solid and presentable and PAR should be able to provide this after 2 P3 trials but they do have to cross all their t's and dot all their i's and be ready for all manner of questions around the science. And PAR holders have to watch out for the kind of traps set that some MSB holders fell prey to. Rule number 1 is believe nothing that the AFR write! Rule number 2, don't 2nd guess your own research and that of trusted sources at the 11th hour. It's easy to feel comfortable with your decisions now however when it's 5 minutes to midnight and you're at the make or break juncture you will be surprised how your decision making faculties are tested!
Just some notes from the bunker. Bring on PAR's turn at the table!
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