FACT: ALL IR opioids have THE SAME T-Max “issue”—i.e. fatty meal slows down absorption. So the same safety labeling used by other FDA approved opioids (including Opana IR Oxymorphone) should similarly be sufficient for SequestOx! NAMELY “TAKE ONE HOUR BEFORE A MEAL OR TWO HOURS AFTER A MEAL. TAKE NO MORE THAN 2 PILLS EVERY FOUR HOURS”.
THERE IS NO MEDICAL REASON to make the rules for dealing with the SequestOx T-max situation any different than for any other IR Opioid pain med!!! There is no more chance of over-dose on SequestOx than for any other IR Opioid pain med!! FDA KNOWS THIS! THAT IS WHY FDA IN 2014 TOLD NASRAT THAT LABELING INSTRUCTIONS WERE ALL THAT WAS NEEDED TO DEAL WITH THIS T-MAX ISSUE!
The FDA did a switcheroo at the last minute (after having granted ELTP a $2.5 million fee waiver and after having granted ELTP priority review). THERE WAS NO MEDICAL REASON for this switcheroo! THERE IS NO MEDICAL REASON why full approval was not granted on July 14th!!! It was obviously a politically (and/or financially) motivated decision in order to stall the entrance of SequestOx into the marketplace (or for some other politically motivated reason. FDA director Robert Califf was well known to Congress as a BP lobbyist before his appointment so it seems likely that conflict of interest was involved But additional political reasons also possible).(See No2Kool-Aids posts on this).
However, other political pressures exist to strongly motivate Califf to approve SequestOx because Congress wants ADF opioids to be available to replace non-ADF opioids that are causing so much abuse, death and enormous cost to the American people. Therefore, it is in Califf’s best interests to soon grant approval for SequestOx, which he will do. Our guy Eugene will get this problem resolved just like he’s previously gotten many other difficult problems resolved.
