Elite Pharmaceuticals Inc (ELTP)

[Couch]

Any Questions? Here's the Answer! $$$$$$$$$$$$

Congress Pressures FDA to Finalize Opioid Guidance

http://www.medpagetoday.com/Psychiatry/Addictions/50541

The FDA will publish its long-awaited guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner's office threatened by Congress.

Indeed, an FDA spokesperson told MedPage Today that the organization "is aware of the provision and we are working to finalize the guidance before the June 30, 2015 deadline."

~~~ So let's say the FDA's official Abuse Deterrent Guidelines comes out by June 30, 2015. Plenty of time for Elite to file its first ADT NDA by AND have Nasrat hit the Pharma circuit and beat the ELTP ADT drum and push to find a BP partnership.

The FDA will answer us in the middle of March. And that's when we will initiate the study. We have already lined up five sites nationally, recruited patients, written protocols and have all of that ready for the day we get the feedback from FDA that they agree with us or they want certain things modify that we will hit the ground running. This is why eight weeks from the middle of March we can have that
study completed. Afterword’s we need to make sure that the blood samples are analyzed, the report is written and our target date for filing is Q3 of 2015.

https://clinicaltrials.gov/ct2/show/NCT02401750?term=%22Elite+Laboratories%2C+Inc%22&rank=2

~~~And let's play devil's advocate and say the FDA is going to be aggressive in pushing pharmaceutical company's to have all their opioids contain ADT by the year 2018. What happens to those companies that don't have any abuse deterrent technology? Might make sense for Elite to license out some of their technology and certainly makes Elite a better buyout candidate.

The FDA told us in writing throughout our communication that we qualified for expedited review. So from the time we file, usually they take six months, I hear it's six to eight but they say six months. So if we file in Q3, by Q1 of 2016 we will be receiving approval on launching a product.