Elite Pharmaceuticals Inc (ELTP)

[Couch]

This is why Nasrat can so easily say Nobody Will Stop Us - not even the FDA.

1) Elite already knew back in 2005 that Eli 216 (Oxycodone and Naltrexone) when administered as intended did not release any naltrexone and thus none was absorbed. Here's the important piece for Eli 200 Phase 3 Efficacy Study. Eli 216 in this study -- the oxycodone showed a typical release profile for a 12-hour product, thus provides the desired effect of pain relief.

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74997&GoTopage=7&Category=2163&BzID=2258&t=1960&G=939

In essence, Elite already has data that shows Elite's ADT when taken as intended releases a typical amount of oxycodone. As long as Eli 200 matches Eli 216's release profile then Eli 200 Phase 3 trial should be a slam dunk. Notice that Naltrexone AND Oxycodone levels were measured in the subjects' blood.

2) Eli 216 already was proven to show positive HAL testing back in 2007. In essence, Eli 200 HAL studies merely backs up the results shown in Eli 216.

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74976&GoTopage=5&Category=2163&BzID=2258&t=1960&G=939

So Elite has already shown that its ADT properties are reproducible!!

Then you have 2 different studies Eli 201 and Eli 200 that showed these two products were bioequivalent to comparator drugs.

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74671&GoTopage=2&Category=2163&BzID=2258&t=1948&G=939

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74683&GoTopage=3&Category=2163&BzID=2258&t=1948&G=939