Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Collegium had no problem with Xtampza...(an ER)..didn't seem to be a long and difficult path for them....it was the hair brained 2 bead tech that stopped Elite in its tracks

First of all, there is an obvious lack of understanding of how Xtampza got approved. It never should have been. It was still subject to patent infringement over the 12 hour oxy formula. One single judge bought Collegium's argument about the VENUE and dismissed the case. Before Purdue could re-file in the proper court, FDA took the opportunity to approve the drug. As far as I know, they've never done anything like that before or since. Why did they do it? Xtampza is just better in multiple ways, but it is much better to prevent chewing/oral dose dumping. They made a better product, and the FDA found a way. But legally it never should have been approved. Once it was approved, a judge refused to give an injunction to stop it, but it is possible that Collegium will still have to write a very large check to Purdue.


In other words, let's stop pretending that Xtampza's Stardust Approval was a typical event. By the normal rules, that drug would still be tied up in court.