Soligenix announces Type A meeting with FDA for HyBryte NDA

Soligenix announced that the U.S. FDA has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s new drug application for HyBryte in the treatment of early stage cutaneous T-cell lymphoma, a rare cancer, where it has successfully demonstrated statistically significant results in a Phase 3 clinical trial. "We look forward to the Type A meeting which will provide an opportunity to discuss the issues raised in the RTF letter with respect to the NDA for HyBryte in CTCL," stated Christopher Schaber, PhD, President and CEO of Soligenix. "We remain determined to work with the FDA staff as quickly as possible to better understand the open issues and clarify the potential path forward. We intend to provide a further update once we have received the minutes from the meeting or when we have more clarity on next steps, which we anticipate having by or before the end of April."