FDA "Fast Track" for Soligenix' SGX942 for oral mucositis in patients with head and neck cancer

3 June 2013

US clinical-stage biopharma firm Soligenix (OTCQB: SNGX) says that its SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients has received "Fast Track" designation from the US Food and Drug Administration.

This means that, should events warrant, Soligenix will be eligible to submit a New Drug Application for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

Addresses unmet medical need

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