Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Camargo is exactly who I blame.

All of this... and please Mr Wee Zhul do not blame Camargo... this is on the FDA.

Well, buck stops with Nasrat, but Camargo served him very poorly. Who advised him not to conduct pilot studies for 200? Camargo? This issue could have been identified and rectified much sooner before expensive pivotal study. Who advised him to continue with non-bioequivalent molecule? Camargo? Who conducted the Phase 3 trials that caused FDA to reject? Camargo? Who was supposed to be running this show? It says on all the PR's:

The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.

Again, anyone who believes Nasrat was blindsided by this needs to open their eyes. The SequestOx AdCom took place in September 2015. It was for Avridi, an IR oxy with sequestered naltrexone and delayed Tmax under fed conditions. Sound familiar? AdCom voted overwhelmingly against, and that was 3 months before SequestOx was filed. The FDA was on record on this exact issue before SequestOx was filed, so blaming FDA is without any basis in reality.

09.11.2015
FDA Panels Nix Avridi Reformulation
Panelists say safety concerns outweigh benefits of abuse-deterrent, immediate-release oxycodone

WASHINGTON -- In a joint meeting of two FDA advisory committees, panelists voted 23 to 1 against approval of Purdue Pharma's immediate-release oxycodone (Avridi).

Panelists' main concern was that the drug's requirement to be taken on an empty stomach would be too complicated for patients to manage -- and if it wasn't followed precisely, it could lead to an increased risk of adverse effects, including overdose.

"The problem here is that they have developed something with a beneficial abuse-deterrence property, but the product is inferior to the one on the market from the standpoint of how it will work in the most common patient population that needs it," said panelist Sharon Walsh, PhD, of the University of Kentucky.

"It might give providers a false sense of safety because it has a label of abuse-deterrence, but in reality it adds a safety concern," said advisory committee chairperson Almut Winterstein, RPh, PhD, of the University of Florida.