Apr. 2 at 8:29 PM
$BHVN Sequence of Events:
Nov 5, 2025: Biohaven receives CRL.
Dec 3, 2025: Dr. Tracy Beth H becomes CDER Director.
Feb 13, 2026: Biohaven CEO Vlad C calls the FDA's decisions a "systemic problem" and "uncooperative".
Feb 23, 2026: FDA officially launches the Plausible
March 31, 2016: Tweet about BHVN recent meeting with FDA Chief Counsel (posted by a Jeff C referencing BioCentury article) Mechanism Framework to accelerate rare disease approvals.
Context: This framework was released after the CEO's public statements. It provides a specific "playbook" for the FDA to approve drugs based on disease biology and natural history data when traditional trials aren't feasible. SUMMARY: SOMETHING IS BREWING AND IF POSITIVE WE SHOULD KNOW SOON (potentially by earnings).