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Thursday, 06/11/2015 8:13:37 PM

Thursday, June 11, 2015 8:13:37 PM

Post# of 399705
A few more additional FACTS about the Actavis/Epic/Elite connections that Nasrat is the key to AND additional REASONS I would not want to bet against Nasrat.

1) Notice the highlighted RED portion below. Nasrat has had EXTENSIVE dealings with the FDA while at Actavis. It's why he knows how to deal with the FDA professionally.

Actavis was/is one of the handful of companies that distributed generic oxycodone and a limited supply of Purdue's ADT OxyContin.

http://www.law360.com/articles/436327/purdue-actavis-settle-oxycontin-patent-battle

When Actavis reopened their Little Falls NJ plant in 2009 after closing it down.....notice it called on Nasrat to get it back in tip top shape and re-launch generic Oxycodone.

“Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging – and we re-qualified and revalidated all methods used to release products from our Totowa facilities,” said Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis Inc. “This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the Consent Decree.

The FDA completed its inspection and approved the release of the first two products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets. Subsequent inspections, also as outlined in the Decree, will follow.



2) Notice in 2009 who Actavis hired as their Managing Director of the New Jersey Solid Oral Dose Operations. Yep, Elite's VP of Operations ~ Doug Plassche.

From 2009 to 2013, Mr. Plassche was employed by Actavis as Managing Director of the New Jersey Solid Oral Dose Operations, overseeing 450 employees and the production of more than 100 products.



3) Now at some point Actavis needed additional help manufacturing its generic oxycodone. Who did it pick you might wonder. YEP: EPIC .....take a look.

http://dailymed.nlm.nih.gov/dailymed/image.cfm?type=img&name=c088a64a-figure-04.jpg&setid=df9313c5-e454-4829-bbb7-2f26d9f85e1e

4) Now recall Epic had a lawsuit with Purdue pending in which Epic was not able to get their own Oxycodone ANDA approved. Notice that Actavis at the time was involved with Purdue legally as well.

http://www.law360.com/articles/411658/purdue-hits-2-generics-makers-with-oxycontin-patent-suits

5) So anybody want to tell me that EPIC isn't a solid player when Actavis comes to them for manufacturing help regarding Oxycodone.

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77479&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

6) Now, notice in Elite's PR that Epic has an ADT ER Oxycodone product.

"Epic is pleased to have an opportunity to market this important new product and to add to our current pipeline of opioid products that includes a pending application for an abuse-deterrent oxycodone HCl extended release product," said Dr. Ashok Nigalaye, Chief Executive Officer of Epic. "ELI-200 will allow Epic to extend its reach in the anti-abuse pain space, and to position both companies for long-term growth."



7) So now you will have EPIC going to marketing its own ER ADT OXY and Elite's IR ADT OXY at the same time!!! THAT IS HUGE.

8) What I'm curious to know more about and think it would be a solid question to ASK during the CC ~~~ That Epic ADT it will be using.....will that be a hard turtle shell version like Purdue/Actavis has agreed upon.......OR is EPIC going to using a version of Elite's ADT??? AND if so, can you say LICENSING AGREEMENT.



Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.

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