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股价在FDA A类会议上上涨，讨论Vicineum回复信中的问题
- 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已经批准SESEN Bio Inc.‘s(纳斯达克股票代码：SESN)要求召开一次A型会议，讨论Vicineum对卡介苗反应不敏感的非肌肉浸润性膀胱癌的完整回复信中提出的化学、制造和控制(CMC)问题。
- 相关： SESEN生物股票暴跌，FDA猛烈抨击膀胱癌.
- CMC A类会议已定于10月29日召开。
- 该公司还准备召开一次单独的A类会议，讨论针对CRL中提出的额外数据和分析提出的具体建议。
- 该公司预计A类临床会议将于2021年第四季度晚些时候举行。
- 另请阅读： SESEN BIO的膀胱癌试验被不当行为破坏：统计新闻。
- 相关内容：本辛加已经满了FDA日历.
- 价格行动：在周三最后一次检查的盘前交易中，SESN股价上涨11.9%，至1.13美元。