[scld]

The US meeting date is based on an arbitrary scheduling rule saying meetings like this must take place 15 days after request, or something to that effect.

The FDA itself closely inspects data throughout the phase 3 trials so this review should just consist of looking at the details to see if something was missed, (ideally) not some brand new information come to light.

[marricks]

Wow, thanks for the info. I didn't know it was arbitrary scheduling. Seems like given the circumstances you'd hope they would just setup a meeting tomorrow.