In reading multiple boards, including this one, I’m seeing posts about BTD of LL as if it’s an approval.

It’s not.

It’s exactly what the name suggests, a designation. With the “approval” of that designation we would see many benefits. Helpful things such as more investor eyes on our baby, big pharma suitors, and an expedited path toward approval among others.

But ultimately we still will need to run as many trials as necessary and jump through an annoying large amount of hoops to ultimately appease the almighty FDA overlords and gain acrual approval.