Thought on UNCY Timing
The original tableter subcontractor of Shilpa was assigned inspection 14 weeks or so ago. It had a successful inspection by EU regulators since the first CRL. It also has present US commercial supply.
Given the aforementioned points, the probability of a successful inspection this month is reasonable. If this happens, there's a potential timing benefit as Unicycive will seek FDA alignment on a shorter approval timeline for the resubmission. In my view they would likely only say this if they were referring to proceeding without review of the additional vendor, so that the six month route would not be necessary. The alternative route is the two month Class 1. They're not explicit about this but it appears to me to be implied.
My speculation is that this resubmission is a legitimate acceleration of the timeline by getting the NDA in and the clock started without waiting for the inspection. I believe the probability of a 2026 approval is reasonable.
Not financial advice - please don't make investment decisions based on my view without doing your own research.