Rusty let’s be honest “soon” is not correct. 15 months to enrol 5 patients. They don’t jump straight from one trial into another, lots of approvals needed, setup time.. then a much larger pivotal trial which will take 1-2 years (longer if they don’t improve the trial design), then accumulation of data and readout, then getting a package ready for regulatory submission and liaising with the FDA which is an absolutely painful back and forth. 5 years is being generous.
Ann: First-in-human Study Progress Update, page-103
-
- There are more pages in this discussion • 93 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
