Dr. Margaret Hamburg FDA approved SequestOx Tmax with Pamphlet/Label instructions in 2014/2015 and then Dr. Robert Califf FDA stiffed $ELTP SequestOx in Jul 2016 for the benefit of Pfizer Troxyca approval a month later in Aug 2016
Thanks but the first indication I had that Elite was in trouble with the TMax issue was when Purdue's Avridi was denied via their AdCom.......and Elite had already filed their NDA and the FDA had signed Elite's phase 3 trial already telling Elite the TMax situation was a labeling situation.