2013~~The Perfect Storm Is Nearer Than Any Of Us

2013~~The Perfect Storm Is Nearer Than Any Of Us Know:

1) FDA’s draft guidance, Abuse-Deterrent Opioids—Evaluation and Labeling, hopes to speed the development of abuse-deterrent opioids.

http://www.fda.gov/NewsEvents/Newsroom/PressA...334785.htm

~~Note: The FDA is going to allow Labels on products that provide data that supports abuse deterrent properties. Which means that Elite will be one of the few companies that will have the ability to market their opioids using claims that it is more abuse-deterrent. Then you add in the that Insurance companies will move toward prescribing abuse deterrent opioids over non abuse deterrent opioids and Elite's Abuse Resistant Technology is indeed a Game Changer.

~~Note: The next phase of FDA debates/decrees will be around Abuse Resistant Generic Opioids and we know Elite has this ability as well. In essence, if newer Branded Opioids with Abuse Deterrent properties such as Eli 216 has shown the real likelihood of having....The FDA will have the legal authority to require generic versions to carry abuse deterrent equivalent properties as well. And we all know Insurance companies are going to continue to push for paying for less expensive generic drugs.....abuse deterrent or not!

http://energycommerce.house.gov/sites/republi...sponse.pdf

~~Note: The FDA is also providing incentives in the form of fast tracing those abuse deterrent products for priority review. What this means is that review decisions can come as quickly as six months. Thus, halving the amount of time the FDA usually takes to review a product.

2) ELITE PHARMACEUTICALS ANNOUNCES ISSUANCE OF U.S. PATENT FOR ABUSE RESISTANT ORAL DOSAGE FORMULATION.

http://www.elitepharma.com/investor_relations.asp?goto=344

The issuance of this patent will further protect Elite’s proprietary formulation for abuse resistant products utilizing the pharmacological approach. The Company has additional patents pending for its technology.

Note:This next Eli 216 Patent for formulation looks to be allowed by the USPTO shortly and thus, in timely accord with what the FDA is pushing for in Point #1. And thus, other pharma companies, particularly Big Pharma companies that do not have their own Abuse Deterrent Technology and opioids will want to look towards companies like Elite to access that kind of technology.

Note: Here is the upcoming Patent under review: Some Believe Allowed w/in even a few weeks.

Patent Pending Approval - 12/640,344 – Abuse resistance

http://www.google.com/patents/US20100098771?d...CDYQ6AEwAA

An opioid-antagonist oral dosage form which does not release a therapeutically effective amount of the opioid antagonist when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the therapeutically effective amount of the opioid antagonist. An embodiment of the oral dosage form includes an opioid-antagonist layer coated onto a biologically inert pellet, and a non-releasing membrane coated onto the opioid-antagonist layer. Optionally, the oral dosage form can also include an opioid agonist, such that a method of preventing the abuse of an oral dosage form of an opioid agonist is provided by forming the oral dosage form including an opioid agonist and an opioid antagonist.

~~REMARKS: Claims 1-8 are pending and no claim amendment have been made. The only rejection of these claims is the one for obviousness-type doubling patenting rejection over the claims of U.S. 8,182,836. With not conceding to the propriety of the rejection, Applicants file a terminal disclaimer herewith to obviate the rejection. Claims 1-8 are now in condition for allowance. Date: January 11, 2013: Stephanie Barbosa

3) The company has publicly stated it is looking to create a large patent estate around their Abuse Resistant Technology both in the US and Internationally and additionally looking to undertake Bioequivalency studies within this fiscal year. From #2 we can see the company is on its way to doing just this. What this means however is that the company will need a cash inflow to help them with the costs of bringing these abuse resistant opioids to market based on their patented technology. Here are a few ideas the company is already looking into.

a) Get an Anda to market with their Abuse Resistant Technology to show Big Pharma the Technology is sustainable and then partner with say an Actavis for Phase III trials of Eli 216.

b) Monetize their 10% of Novel Pharma and depending on the amount wipe out their bond debt issue, buy another Anda or two and if they have enough money left over fund half or all of the Phase III themselves. It should be noted that Elite, if possible, would likely rather partner with Big Pharma for nothing else than distribution help within the US and internationally.....as Elite's patent estate will be international as well.

c) After Novel's stake has been monetized Elite may indeed still want to take a portion of the Socius $5 million Dollar financing deal. I personally hope they don't have to but the company needs cash one way or another.

4) Cash Flow Positive. As numbers 1-3 are happening simultaneously the company is becoming rather close to hitting the $4 million dollar mark it needs to become profitable. Once this happens it should wipe out some of the previous difficulties with the PPS being held down. As our CEO has stated:

Quote:

Just like previously, that requires us to get to an annual run rate of a little over $4 million, and Carter can correct me if I'm wrong about that, but I think that's correct. We are getting there; we're definitely getting there. With a little help from the FDA, we will get there in fiscal 2013

~~Note: Here are a few things that will help the company with hitting that $4 million dollar mark.

a) NJEDA tax gredit 920k JAN

b) The continued sales of Elite's existing pipeline on the market as they are all in their infancy. All less than 24 months old!

c) Phentermine 15 and 30 mgs tablets...milestone payments from Tagi which should put Elite over the 1 million dollar mark for operations revenue.

d) Elite has several other products in its pipeline waiting for launch as well that will bring in added revenue when that happens: Naltrexone, Mik001 NDA, Undisclosed Opioid Anda, Epic drug 1 of 8, HK NDA, Hi Tech intermediate

SIDE NOTE: And least we forget the almost forgotten possibility that Elite gets bought out or merges with a Big Pharma company such as Actavis. This is a possibility down the road particularly as Elite wipes out its debt, moves towards profitability and able to show the market it is able to monetize on those aforementioned Abuse Resistant Technology (ART), products and patents.

~~Merger and Acquisition Activity Expected to Rise in 2013 as Big Pharma Companies Flush With Cash

http://www.marketwire.com/press-release/merge...744766.htm

NEW YORK, NY--(Marketwire - Jan 11, 2013) - Lost revenues from expiring patents has played a major part in the Biotech Industry's success in recent years. A total of 676 takeovers of biotechnology and pharmaceutical companies have occurred in the past three years, with an average premium of 38 percent, according to data collected by Bloomberg.