Sesen Bio Shares Gain On FDA Type A Meeting On Issues From Vicineum Response Letter
Sesen Bio Shares Gain On FDA Type A Meeting On Issues From Vicineum Response Letter
SESEN Bio股價在FDA A類會議上上漲，討論Vicineum回覆信中的問題
- The FDA has granted Sesen Bio Inc's (NASDAQ:SESN) request for a Type A meeting to discuss the Chemistry, Manufacturing, and Controls (CMC) issues raised in the Complete Response Letter for Vicineum for BCG-unresponsive non-muscle invasive bladder cancer.
- Related: Sesen Bio Stock Crashes As FDA Shoots Down Its Bladder Cancer Pitch.
- The CMC Type A Meeting has been scheduled for October 29.
- The Company is also preparing for a separate Type A meeting to discuss the recommendations specific to additional data and analyses raised in the CRL.
- The Company expects the Clinical Type A Meeting to happen later in Q4 of 2021.
- Also Read: Sesen Bio's Bladder Cancer Trial Wrecked By Misconduct: Stat News.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: SESN shares are up 11.9% at $1.13 during the premarket session on the last check Wednesday.
- FDA已經批准SESEN Bio Inc.‘s(納斯達克股票代碼：SESN)要求召開一次A型會議，討論Vicineum對卡介苗反應不敏感的非肌肉浸潤性膀胱癌的完整回覆信中提出的化學、製造和控制(CMC)問題。
- 相關： SESEN生物股票暴跌，FDA猛烈抨擊膀胱癌.
- CMC A類會議已定於10月29日召開。
- 該公司還準備召開一次單獨的A類會議，討論針對CRL中提出的額外數據和分析提出的具體建議。
- 該公司預計A類臨牀會議將於2021年第四季度晚些時候舉行。
- 另請閲讀： SESEN BIO的膀胱癌試驗被不當行為破壞：統計新聞。
- 相關內容：本辛加已經滿了FDA日曆.
- 價格行動：在週三最後一次檢查的盤前交易中，SESN股價上漲11.9%，至1.13美元。