I asked Bing AI:
How long on average does it take the FDA to review an NDA (New Drug Application)?
" The FDA team has 60 days to review the New Drug Application (NDA) and determine if it will be filed for further review1. The Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90% of NDAs for standard drugs no later than 10 months after the applications are received1. The review goal is six months for priority drugs1. However, these timelines can vary based on several factors such as whether other similar drugs already exist or whether your drug treats an unmet medical need2.
The FDA reckon it will be 26th Spetember 2024 for final decision on KarXT (for those that don’t click!)
Yesssssssss. Looking forward to this drug a lot
I predict July 2024 approval.
I agree. What seems strange to me is that the FDA has not ruled KarXT a priority. With Ulotaront they did it. This speeds up the approval procedures.