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.
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...