Again, A CRL is not a rejection and we will see whether this comes down to a "safety issue" when all is said and done particularly when ZERO adverse effects can be found in the literature from taking too many pills after a heavy meal or any adverse effects in relation to Elite's Phase 3 efficacy trial.
So in the real world application SequestOx relieved pain as it should plus it is able to detour abuse via crushing, snorting or shooting the drug.
So again in the real world the BENEFITS of SequestOx greatly outweigh and theoretical risks from taking too many pills after a fatty meal. Got it.
This clearly should come down to a labeling issue as the FDA stated previously.
So my bet a short BE trial with a heavy meal and then a label is slapped on SequestOx. Eugene was hired for a reason and he is a legal expert.
More like what other IR Oxy drugs on the market have better ADT than SequestOx.