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FINWIRES

オンコリティクス・バイオテック社、肛門がん治療薬ペラレオリップの臨床試験デザインについてFDAと合意

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-- オンコリティクス・バイオテック(ONCY)は月曜日、米国食品医薬品局(FDA)との会合で、切除不能な転移性肛門管扁平上皮癌患者に対するペラレオリップの承認を裏付けるための臨床試験の設計方法について合意に達したと発表した。 同社は、規制当局からのフィードバックを基に試験計画を最終決定すると付け加えた。この試験は単一の無作為化比較試験となる見込みで、迅速承認と段階的な正式承認の両方を裏付ける可能性があると同社は述べている。

Price: $1.07, Change: $+0.04, Percent Change: +3.88%

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