Refusal to File Letter issued from U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma
“We are fully determined to work with the FDA staff as quickly as possible to better understand the open issues and clarify the potential path to successfully resubmitting our application,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We remain focused on advancing HyBryte™ as a potential new first-in-class treatment option for the CTCL community of patients, families and healthcare professionals.”
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