Apr. 30 at 1:16 PM
$BHVN More on working with the FDA on Vyglixia. Can the Chief Counsel Overturn the Rejection?
Directly, no—the OCC provides legal advice, not scientific judgment. However, the meeting could find a "new path forward" in several ways: Enforcing "Regulatory Flexibility": CEO Vlad Coric has argued that the FDA's Office of Neuroscience ignored the 21st Century Cures Act, which mandates flexibility for rare diseases. If the OCC agrees that the review division ignored these legal standards, they can advise leadership to reconsider the application.
Procedural Missteps: Biohaven criticized the FDA for canceling an Advisory Committee meeting just weeks before it was scheduled, after the company had spent significant resources preparing. The OCC could recommend a new, formal hearing with outside experts.
APA Claims: If Biohaven can show that the FDA was "arbitrary and capricious"—for instance, by endorsing a study protocol 2024 and then rejecting data n 2025.—the OCC may step in.
