AQUA AND LASERS--There is no problem or error whatsoever with SequestOx! The only problem is $$$$$$$ BP/FDA collusion to stall entry of SequestOx into the marketplace! SequestOx would (and ultimately will) contribute significantly to solving the huge problem of opioid addiction in new users (i.e. non-addicted ones) of pain meds who need them for pain reduction (not for getting high).
The same label that is used on all other IR opioid meds ("Take one hour before a meal or two hours after a meal") should be entirely sufficient for SequestOx. There is no logical reason to require anything more. Abuse deterrent SequestOx takes care of pain in exactly the same way as the other opioid meds. The only difference is that you can’t get high from crushing, snorting or injecting it. Therefore, there's far less chance of over-dosing!
As to the notion that the CRL was due to a big change in the climate of the FDA since 2014, the 2.5 million fee waiver for Elite’s application and the priority review were both granted just a few months ago, quite a long time after 2014. Fact is, the rug was pulled out under ELTP at the eleventh hour.
The “big change” in FDA is in the person of director Robert Califf, whose potential appointment was a matter of serious concern to many in Congress specifically because he was known to be a lobbyist for BP. Now we see that this concern was well justified since, as head of the FDA, his first priority appears to be doing what is best for BP instead of what is best for the health of the American people.
