RE:RE:RE:RE:Advisory Committee Outcomes
Winx:
An estimated guess as it's halfway through our 6 month period.
The FDA website has the Oncologic Advisory Committee meeting Nov 19-20. I think they meet 3-4 times a year ish , so the next meeting would be about late Jan - Feb '16 , cutting it close for Feb 27.
The FDA usually follows it's recommendation , however , it is NOT binding. So don't anyone get their panties in a knot if they recommend a no go. FDA can still say yes.
All briefing material to be made public two days before actual meeting on website.
Not sure about the 55 business day thing. Does it start when they are notified on Aug 28? Or if they have an issue with something? See link and scroll to Appendices page 17-20 https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf. Telesta to submit everything 22 days before meeting.
This is just my take , could be wrong.
Cheers
GLTA Longs
13PD