SAN DIEGO, Feb. 20, 2018 (GLOBE NEWSWIRE) -- Vical Incorporated (VICL) announced today the initiation of a Phase 2 trial of the Company’s VL-2397 novel antifungal compound.
The U.S. Food and Drug Administration (FDA) has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency's advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. The LUI is a provision of the Limited Population Pathway established under the 21st Century Cures Act of 2016.
バイカルもしぶとくVＬー2397のフェーズ2を開始するようです。FDAのLUIの対象になるので、フェーズ2の結果がよければ限定的な商業化が認められる様子。アンジェスのためにも頑張って欲しいものです。
SAN DIEGO, Feb. 20, 2018 (GLOBE NEWSWIRE) -- Vical Incorporated (VICL) announced today the initiation of a Phase 2 trial of the Company’s VL-2397 novel antifungal compound.
The U.S. Food and Drug Administration (FDA) has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol and statistical analysis plan consistent with the Agency's advice. The final determination whether the drug is approvable will be made by FDA after review of all relevant data. The LUI is a provision of the Limited Population Pathway established under the 21st Century Cures Act of 2016.