Today's meeting is about manufacturing, the June 6 meeting is about the BLA submission. From a Friday afternoon SA article:
"A Type C CMC meeting is scheduled for May 20 to discuss the best path for the transfer of technology to Fujifilm to ensure that product quality and integrity are maintained. Per the press release, the recently completed full-scale GMP manufacturing run at Fujifilm’s facility yielded “encouraging preliminary results”. The June 6 pre-BLA meeting’s primary objective is to obtain feedback from the agency as to whether the efficacy and safety data, benefit-risk profile and overall information that has been compiled is adequate for BLA submission. Among oncology products reviewed by the FDA between 2006 and 2015, the approval rate for those that get through BLA filing is 82%, significantly higher than the 33% that get through Phase 3. (bold highlight is mine)
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.
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