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Soligenix submits Type A Meeting Request to FDA for HyBryte
The Fly

Soligenix submits Type A Meeting Request to FDA for HyBryte

Soligenix announced that the company has submitted a Type A Meeting Request to the United States FDA to discuss the contents of a refusal to file letter previously issued by the FDA 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. The Type A Meeting is expected to occur approximately 30 days from the FDA’s receipt of the meeting request.

Published first on TheFly

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