Sesen Bio Shares Gain On FDA Type A Meeting On Issues From Vicineum Response Letter
- 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.
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