RE:M80Hey Bio,
There is no truth in this (press release announcing an early approval of MCNA). Looks like a misinterpretation from the priority review TST got at the end of august. Meaning an FDA decision by the end of february instead of june 2016.
Maybe account15 is open to share what he knows on why TST should have an answer before the official PDUFA date, being february the 27th. From what I know, they rarely release their decision more than a few days before the PDUFA date. I don't expect this one to be any different, although I'd love to see a yes from the FDA by the end of january.
Hope you'll be able to read this in the next 30 min...before it gets buried : )
M80