Elite Pharmaceuticals Inc (ELTP)

[Dante Fantasia]

Actually, luvwetscent, what I meant more specifically was the opioid beads. The naltrexone were engineered not to break open *like in stomach acid etc.) unless crushed for chewing, snorting, shooting. They seemed to work. That is where one would expect a mistake if any...but that was not the issue.

The T-max issue comes from the opioid beads not opening quick enough to have come close to the normal T-max criteria. They were almost double in the submission. Thing is--if one makes generics, then the opioid bead should work exactly the same as all opioid beads (thus a generic) and the T-max also the same. The screw-up of such a delayed T-max points to an issue of the regular generic encapsulation not working as it should, as a "generic," and thus indicative of a complete blunder on something claimed to be a core competence of the company" Producing a generic. If it were the naltrexone, then I would say it was a more complex scientific issue that the company got wrong as opposed to gross incompetence.

Makes me wonder, how many of their actual generics have such a T-max issue, and if not, why the issue only with SOx? Unless the T-max was only of several problems, and the one used to "disclose" the CRL rationale to investors? This never made any sense.