Sesen Bio Inc (SESN)

[Tex18]

Meeting today is to discuss the technology transfer with Fujifilm to ensure the commercial supply of Vici is of the same standard as used in the trials- that no quality is sacrificed on Fuji’s end which could materially affect the effectiveness of the drug.

The meeting June 6th is to discuss pre-BLA submission, to ensure all ducks are in a row for Sesen to submit the application shortly after the meeting (assuming all details are there and are sufficient).

Turnaround time from time of submission to FDA decision could be between 60-120 days? From what I’ve heard. Fast track plus BCG shortage could spur the FDA to approve sooner but I would expect a quarter between submission to approval decision.