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.
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.
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