Oncolytics Biotech Reports Submission Of A Type C Meeting Request To FDA
Oncolytics Biotech Reports Submission Of A Type C Meeting Request To FDA
This meeting aims to discuss the company's planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). "We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."
This meeting aims to discuss the company's planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). "We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."
這次會議旨在討論該公司計劃在HR+/HER2-轉移性乳腺癌（mBC）中進行pelareorep的註冊試驗。“我們希望在2024年第二季度與該機構會面，並期待進行富有成效的對話。憑藉 BRACELET-1 研究的預期總體存活率數據以及與美國食品藥品管理局的富有成效的討論，2024 年對於腫瘤學家和我們的利益相關者來說有望成爲變革性的一年。”
譯文內容由第三人軟體翻譯。
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