The key takeaway that I have is that the FDA believes that T-Enox is completely Approvable at this point.
If the FDA thought that T-Enox was NOT approvable they would have issued a major deiciency letter and let Teva answer whatever objections prior to denial.
Teva still has to answer whatever concerns that the FDA has before the drug is approved.
I don't really have a better insight as Teva didn't give the list of questions. My hunch is that Peter, Roy, and Jim will have dinner in a fancy restaurant sooner than I though.