Definitely longer than I'd expect for "cleared" considering everybody involved should have to be licensed and pretty sure you pay a fee to the FDA so that should cover the cost of FDA hiring employees to just call each person involved to verify the submission is accurate.
Although IIUC, they were already allowed to do 50yr+ people and the recent clearance is just for 40yr+ so I'm not actually sure how uh impactful this is (a bit more confused why it takes 10 months to drop the age by 10 years).
Comments
October[1] to August[2] isn't even a single year.
Definitely longer than I'd expect for "cleared" considering everybody involved should have to be licensed and pretty sure you pay a fee to the FDA so that should cover the cost of FDA hiring employees to just call each person involved to verify the submission is accurate.
Although IIUC, they were already allowed to do 50yr+ people and the recent clearance is just for 40yr+ so I'm not actually sure how uh impactful this is (a bit more confused why it takes 10 months to drop the age by 10 years).
[1]: https://precivityad.com/news/c2n-submits-us-fda-regulatory-f...
[2]: https://c2n.com/news-releases/bg2ziqcz39o3wxf5uc04u279ziw0yv