Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Nice summary of the future wins set for Elite and its shareholders...

OBTW: Following the Adcom vote, the FDA made it official today...

The FDA’s reluctance with prescription painkillers at a time the United States is swept by a tsunami of opioid abuse, overdose and addiction was on full display on Wednesday, when the regulator rejected Mallinckrodt’s $MNK abuse-deterrent opioid painkiller, soliciting more data from the UK drugmaker.

The drug under scrutiny was a tweaked version of Roxicodone, an immediate-release formulation of the commonly abused opioid oxycodone that was approved by the FDA in 2000. This reformulation was designed to deter abuse via snorting or injecting. In its CRL, the agency “provided guidance regarding areas of further evaluation necessary to resubmit the NDA for further review,” Mallinckrodt said.