Soligenix has submitted a Type A Meeting Request to the FDA to initiate formal discussions regarding the design of a second, Phase 3 pivotal study evaluating HyBryte in the treatment of early stage cutaneous T-cell lymphoma, a rare cancer, where it has successfully demonstrated statistically significant results in the first Phase 3 clinical trial. The Type A Meeting is the highest priority classification of meeting the FDA grants and is expected to occur approximately 30 days from the FDA’s receipt of the meeting request.
Published first on TheFly
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