alt Hacker NewsBeyond 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. This was enabled by the FDA's CNPV Pilot Program [0]
Previous discussion following the data presentation at ASCO: https://news.ycombinator.com/item?id=48517199
[0] https://www.fda.gov/industry/commissioners-national-priority...
Seriously? So for example the covid vaccine should have been approved in 1 month based on the crisis response or because mRNA approach is transformative, or if it could be made in the US. I feel so much safer knowing a reckless FDA won't be a problem now.