Monday, May 20, 2019 11:25:05 AM
"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)
Link to full article:
https://seekingalpha.com/article/4264984-sesen-bio-looks-better-ever-update
Looking very positive based on reward / risk of Vicinium.
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