Type A Meeting Request submitted to FDA to Review Proposed Study Design for a Second Ph 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma
“During the Type A meeting in April, FDA expressed its understanding of the need for additional therapies in CTCL and its willingness to work with Soligenix. FDA provided significant insights into its thoughts on a clinical study design allowing our team to prepare a comprehensive proposal expeditiously,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We certainly appreciate the FDA’s responsiveness and continued collaboration demonstrated by categorizing this meeting as a Type A meeting. The proposed protocol for the confirmatory study retains the key design aspects from the FLASH study while addressing as much of the FDA’s initial feedback as feasible. We look forward to having a productive meeting with the FDA and obtaining agreement on a pivotal study design that is highly executable as quickly as possible.”
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