Whalatane
6 minutes ago
OLC’s NDA, filed under the 505(b)(2) pathway, was accepted by the FDA in November 2024, with a PDUFA target action date of June 28, 2025. The 505(b)(2) route itself is a good sign—it’s a well-trodden path for drugs building on existing approvals (here, Fosrenol), and historically, it has a higher ap