Jan. 27 at 6:24 PM
$ARVN Forget the daily noise. In Biotech, only one thing matters: The FDA Stamp.
We are marching towards the potential approval of Vepdegestrant.
Why is this PDUFA different?
1. The Unmet Need: This isn't just "another drug." It's an oral PROTAC replacing painful injections (Fulvestrant). Patients want this. Doctors want this.
2. The Partner: Do you think Pfizer put
$1B down without doing their due diligence on the regulatory path? They are experts at navigating the FDA.
3. The Commercial Machine: Once that PDUFA hits, Pfizer's sales team takes over. That is a multi-billion dollar machine ready to launch on Day 1.
The market is sleeping on the transition from "Clinical Stage" to "Commercial Stage."
Approvals re-rate stocks.
I am positioning before the date is set in stone.
$ARVN is a powder keg waiting for the FDA match.