Beyond the data, this approval is notable for the speed from FDA acceptance of their new drug application (NDA) to FDA approval - just over a month. Compare this to the typical 8-12 month timelines we've historically seen for priority and standard reviews, respectively.

Previous discussion: https://news.ycombinator.com/item?id=48517199

FDA press release here: https://www.fda.gov/news-events/press-announcements/fda-appr...