PENNYBUSTER'S PENNY BUSTIN PLAYS!!

[Pennybuster]

$ELTP An Exciting Perspective.








10 REASONS ELTP IS IN THE MIDST OF A PERFECT STORM AND A GREAT BUY NOW $$$$$$

1) ELITE is about to put out the BIGGEST PR in the company's history in JANUARY or sooner.

Quote:As of today our focus remains on ELI-200, on filing it by the end of this year and when I say this year I mean our calendar year meaning December of 2015, by the end of December 2015. We will make an announcement once we receive acceptance of the filing by FDA which most likely will be the first or second week of January unless FDA act faster. So we will file once we receive an acceptance from FDA, we will either issue a press release so have conference call, most likely we'll issue a press release.



2) ELITE is scaling up a SECOND manufacturing line and installed a VAULT to store ELI 200.

This means Elite is capable of launching ELI 200 with its current equipment PLUS a few additional ADT products! PLUS Nasrat plans to file 2 additional NDAs in 2016.

Quote:We are a DEA control facility we have two vaults presently one for the R&D and one for commercial and we have just finished installing a very large vault in anticipation of the launch for ELI-200.



We have installed a second packaging line and we are very close to finishing the construction so we can start the validation and scale up activity. A small note on that. [color=red]The current equipment we have our [GLAS60] would be capable of launching initially ELI-200. Once we activate the new facility then we will have the capability to launch multiple products.[/color]

3) ELITE plans on expanding and beefing up its GENERIC pipeline!!

Elite is currently Cash Flow Positive (CFP) on its operations minus R&D costs and cutting into those R&D costs slowly and surely quarter by quarter! Nasrat stated previously he would go out and buy additional ANDAs worth way more than the existing generic products.

Quote:So what that means is our generic operations are cash positive and as you know that is another key element of our long-term strategy.


Quote:So we’re achieving the growth and the profitability required from generics, at the same time, we also developing [align] of our abuse-deterrent opioid, those are two major plans of our strategy and we’re hitting on both of them or we can check both of those off so far.


Quote:Third the generic product launch, we've launched Phendimetrazine, Isradipine, Hydroxyzine and currently Epic is working on filing Loxapine and Dantrolene by the end of Q1 of 2016. We are working on beefing up our generic pipeline and you will see that happening more in 2016 and hear more about it in 2016.



4) 5 states already passed laws to REQUIRE insurance companies to pay for Abuse Deterrent Opioids. Florida and Ohio could be next as the powers that be are pushing to pass ADT laws in most states.

1) Colorado
2) Utah
3) Maine
4) Maryland
5) Massachusetts

http://abusedeterrent.org/news/Portman-Calls-on-Administration-to-Halt-Harmful-Opioid-Rule.aspx#.VlGpAng3-FI

5) Even with existing pressure on lawmakers to pass abuse deterrent opioid laws, Medicare is showing that it still prefers to pay for cheaper generic non ADT opioids and will do so until forced otherwise.

http://khn.org/news/medicare-drug-plans-favor-generic-opioids-over-those-designed-to-avoid-abuse-study-finds/?utm_campaign=KHN%3A+First+Edition&utm_source=hs_email&utm_medium=email&utm_content=18294693&_hsenc=p2ANqtz-83L8HtGq_OQ-mrezx46wvS6SkU0JKQgFVptr05XwnylCv5_y4RfdVdC-bAopFmm0hNVw9GZKlpHKxTfEeWHpXIv3mbAQ&_hsmi=18294693

Quote:The coverage decisions “suggest that the Part D plans are not considering abuse deterrents as any meaningful part of the coverage decision,” says Caroline Pearson, a senior vice president at Avalere and co-author of the study.

OxyContin is significantly more expensive than generic hydrocodone. A 120-day supply of generic hydrocodone might cost $28, according to Healthcare bluebook, which estimates prices based on a nationwide database of payment data. [A similar prescription of OxyContin, on the other hand, might cost $632, more than 20 times the generic price.


Elite has an answer for this problem as well! It's called ELI 300 and ELI 301. Elite's 2 generic ADT opioids.

http://www.elitepharma.com/pipeline-generics/

6) Once the various states insurance covers abuse deterrent opioids and ELI 200 gets approved, here is EXACTLY why Elite will steal HUGE revenues from the competition. Physicians like Elite's ADT best.

Quote:Physicians call for novel abuse-deterrent opioid agonist/antagonist formulations in survey



http://www.fiercedrugdelivery.com/story/physicians-call-novel-abuse-deterrent-opioid-agonistantagonist-formulations/2015-11-09

A survey of more than 200 physicians found that 31% think opioid antagonists is the abuse-deterrent formulation that is most needed to combat the opioid abuse epidemic--an issue that's been implicated in the startling rise of the death rate of middle-aged white Americans without a college degree.

What type of abuse- deterrent formulation is most needed?

Number (out of 214 respondents)

Opioid antagonist/agonist combination 66 (31%)
Physical or chemical barrier 48 (22%)
Novel delivery system 34 (16%)
Aversion 33 (15%)
Prodrug 14 (7%)
Other or combination of above 19 (9%)
FierceDrugDelivery supplied the question to Quantia MD, the provider of a physician engagement platform that counts one-third of U.S. doctors as its members.

Out of 214 physicians, 66 said opioid antagonists/agonists are the most needed formulation. Opioid antagonists are substances that interfere with the euphoria associated with drug abuse. The deterrents would generally be released and activated only if the product is manipulated, such as during crushing or snorting.

7) Should Elite's ADT prove to be highly effective there is a chance that the FDA would pull all other non ADT opioids off the market in that particular opioid class. Notice from the article link provided below there is considerable pressure being placed on the FDA to follow through on this very possibility.

Quote:"Under its existing regulatory authority, FDA has the ability to remove generic formulations that lack abuse deterrent characteristics from the market, when the additional relative safety of a new formulation of a medication with abuse deterrent properties is available," PhRMA and BIO continued. "We encourage FDA to exercise its authority to continue to protect the public health. FDA should incentivize the development of abuse deterrent formulations, which is in the best interest of patients."



http://raps.org/Regulatory-Focus/News/2015/01/20/21120/Should-FDA-Pull-Non-Abuse-Deterrent-Generic-Opioids-off-the-Market-PhRMA-Bio-Say-Yes/

8) The global market for pain management is growing exponentially and currently sits around $60 billion. Further, the largest segment of this financially is the pharmaceutical industry. Given the aging of our population this number will only continue to grow year after year.

http://www.prweb.com/releases/2011/1/prweb8052240.htm

9) Elite has very similar abuse deterrent technology (ADT) to Pfizer who is the Market Leader in Global Pain Treatment. As Nasrat has said let Pfizer educate the doctors, insurance companies and the public at large about their ADT opioids and Elite will ride their coattails.

http://www.fiercebiotech.com/press-releases/pfizer-market-leader-global-pain-treatment-market-companiesandmarketscom

Further, when the likes of Pfizer and Purdue begin paying to conduct research and public educational studies related to ADT opioids one knows ADTs are the wave of the future.

http://avalere.com/expertise/managed-care/insights/medicare-drug-plans-favor-generic-opioids-that-lack-abuse-deterrent-propert

http://www.teamagainstopioidabuse.com

10) *****My Personal Favorite is Elite will IMO be partnering with a BP for ELI 216 and that whoever this company is stands a SOLID chance of BUYING ELTP out altogether in 2017.



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