Elite Pharmaceuticals Inc (ELTP)

[Couch]

For those wanting to actually discuss matters pertaining to the company:

If you've followed the recent FDA decisions regarding abuse deterrent/resistant products it certainly might leave one to question just how serious the agency is about promoting these type of opioids. On the one hand....Zohyrdo was approved by the fDA and the hydrocodone product has no abuse deterrent features whatsoever.
http://www.medicaldaily.com/fda-approves-hydrocodone-painkiller-zohydro-er-against-advisory-panel-recommendation-261092
.....and the FDA has not publicly stated that if an abuse deterrent hydrocodone product becomes available it would remove all non deterrerent versions. And yet Zogenix has stated that it is working on an abuse deterrent version of Zohydro....hopefully, deciding this after discussions with the FDA.....

....and further the FDA blocked a petition by Endo protecting non abuse deterrent generics of Opana ER from being allowed to be formulated....
http://www.fiercepharma.com/story/fda-nixes-endo-petition-protect-opana-er-generics/2013-05-13

And yet on the other hand the FDA
........on April 16, 2013, the FDA specifically stated that abuse of opioids remains a major public healthcare concern.
http://blogs.fda.gov/fdavoice/index.php/2013/04/the-science-of-abuse-deterrence-progress-toward-creating-safer-opioids/

..the FDA followed this up by putting out their abuse deterrent guidelines for Pharma companies....
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm334785.htm

Thereafter, they made a decision to pull the original Oxycontin NDA from the market for safety reasons, and further disallowing generic copies of Oxycontin.
http://www.cnn.com/2013/04/17/health/fda-oxycontin/

...then the FDA put out safety and labelling changes and post market study requirements for extended-release opioids.
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM368098.pdf

...and if this wasn't proof enough that the FDA is serious about helping pharma companies designing newer abuse proof opioids in October of this year they publicly communicated that the abuse of opioids continues to remain a major public healthcare concern and they proposed the rescheduling of hydrocodone combination products to be more restrictive from Schedule III to Schedule II.
http://www.fda.gov/Drugs/DrugSafety/ucm372089.htm

My point here is that the abuse of opioids remains on the FDA priority list to combat and is a highly visible topic. Should Elite's upcoming trial get fast tracked this should give Elite some further additional visibility it could definitely use at this point. A partner would help this visibility even further but it looks like Elite may go this upcoming trial alone. IMO I hope Elite does just this. If Elite has the goods as it says it does.....go it alone for as long as you can. The pay off will be worth it!