"FDA Late-Cycle Meeting"
I just googled "FDA Late Cycle Meeting Drug Approval".... If you look into the Google News (2015-2013) you can see that this late cycle Meeting with other drug companies was held before they had their AdComs for their drugs. So why in the world TST had this Meeting AFTER their Adcom? Did someone notice this??? Who can explain? https://ecghealthcare.com/whitepaper/white-paper.html https://www.raps.org/Regulatory-Focus/News/2015/10/07/23340/Regulatory-Recon-Califf-Removes-Name-From-Papers-Following-Nomination-7-October-2015/ Want to hear a secret? The Late-Cycle Review meeting is a critical opportunity to positively position your company, clarify important concerns, and prepare for your upcoming Advisory Committee meeting. By streamlining product communication with the FDA, successful drug developers are cutting approval times and improving AdComm meetings. ECG has written a comprehensive white paper with the key principles & practices that should be part of any Late-Cycle Review meeting preparation. Download the free white paper.