Sep. 8 at 10:18 PM
$SANA I missed most of the call and just relied on the transcripts, but it was quite garbbled. The impression I had is everything is still on track for SC451 with dosing before the end of 2026. Two of three milestones are pretty much done and the third is the tech transfer to Fuji, which continues. On the FDA comments, didn't see anything that would cause concern there. In fact, my impression is if you don't get the package / application with all the data in correctly the first time, you only get one chance to make a go at the application. Subsequent amendments and updates, raise red flags and are slower in processing than had it been done all correctly the first time - with everything dotted and crossed. So yes, I'm impatient but understand it's better to get it all through compliance the first and only time before getting the green light on dosing. As Brian mentioned to me, what's waiting a few more weeks or months, in lieu if having T1D forever. On track from what I could read.
