HekaBio 報告說，該試驗的初步結果非常令人鼓舞，它將繼續與其醫學專家合作對數據進行彙編和分析，以準備通過與日本當局協商通過 shonin 途徑尋求上市批准的提交. 在提交給日本當局之前，預計不會公佈臨床試驗的結果。
Alpha Tau 首席執行官 Uzi Sofer 表示：“這是 Alpha Tau 的一個重要里程碑，因為我們希望將我們獨特的 Alpha DaRT 療法帶給世界各地的患者。 在以色列獲得首個上市許可後，我們期待看到來自日本的關鍵試驗數據，並著眼於 2022 年在美國啟動關鍵試驗。日本是 Alpha Tau 的重要市場，我們感謝日本的不懈努力HekaBio 首席執行官 Rob Claar 和他的團隊，以及來自日本主要癌症中心的所有參與這項試驗的研究人員。”
從這篇文章可以得到什麼：
- Japan is an important market for Alpha Tau, and we appreciate the untiring efforts of HekaBio CEO Rob Claar and his team, as well as all of the investigators from leading cancer centers in Japan who have participated in this trial.
- HekaBio has reported that preliminary results of this trial are highly encouraging, and that it will continue compilation and analysis of the data in collaboration with its medical experts, in an effort to prepare a submission seeking marketing approval via the shonin pathway in consultation with Japanese authorities.
- Having secured our first marketing authorization in Israel, we look forward to seeing pivotal trial data from Japan, with an eye toward initiating a pivotal trial in the U.
