Post by
rgonlyfactspls on Oct 14, 2015 9:57am
Givmeabrake...Thank you for sharing this info.
Appreciate you taking the time to find, summarize and share this insightful article ("The Impact of FDA Advisory Committee Votes" - link to article attached below) - Just wish more (beyond this board) could see the stats presented of FDA AdCom "yes" votes and FDA drug approvals (including subsets by designation and if oncology related). TST management has conveyed its strategy to working very closely with the FDA and being well prepared for MCNA's BLA submission (achieving "priority review" designation). And, I have to believe/ am confident this will continue to their "level of preparedness" for MCNA's upcoming AdCom meeting. GLTA. rg - https://lsconnect.thomsonreuters.com/fda-advisory-committee-votes/
Comment by
terr2 on Oct 14, 2015 10:50am
Review Type Committee Yes Votes FDA Approval Decisions (and predictive power %) Standard 45 (58.4%) 37 (82%) Priority 59 (76.6%) 53 (90%) Orphan 9 (60%) 9 (100%) Looks like we would be in pretty good shape following a AdCom positive decision. GLTAL